Advertisement
Journal of Prosthetic Dentistry

Quality of life of patients with implant-retained maxillofacial prostheses: A prospective and retrospective study

      Statement of problem

      Clinical studies on implant-retained maxillofacial prostheses have focused on biological outcomes. An assessment of the effect of prostheses on patients’ quality of life (QOL) by using specific questionnaires developed for this patient population provides important information on treatment outcomes from the patients’ perspectives.

      Purpose

      The purpose of this study was to report patient-based outcomes of implant-retained maxillofacial prostheses and to evaluate the effect of implant-retained maxillofacial prostheses on QOL of participants in a prospective study.

      Material and methods

      Eighty-two participants were treated with implant-retained maxillofacial prostheses. Participants were divided into 2 groups: a retrospective group (participants treated and under care) and a prospective group (participants willing to be treated). The posttreatment patient satisfaction scores for each question were statistically analyzed by 2-way ANOVA with variables of defect type and retention type. The Student-Newman-Keuls test was used to determine any significant differences among the groups. In the prospective group, mean scores before and after prosthetic treatment were compared with the paired t test (α=.05).

      Results

      The details of 54 retrospective and 28 prospective participants were reviewed. The posttreatment results of 82 patients showed that patient satisfaction with implant-retained maxillofacial prostheses was significantly different for cleaning the prostheses and recommending treatment to other people, depending on the defect and retention type. In the prospective group, participants reported significant increases in satisfaction for all questions.

      Conclusions

      Implant-retained prostheses were considered highly satisfactory, indicating good QOL for patients with maxillofacial defects. A comparison of pretreatment and posttreatment assessments revealed that implant-retained maxillofacial prostheses increased patient QOL.
      Clinical Implications
      The results of this study indicated a considerable improvement in the quality of life of patients with maxillofacial defects after receiving implant-retained prostheses. Considering patient-related factors may help clinicians to determine the most suitable reconstructive plan for patients with maxillofacial defects.
      Quality of life (QOL) is defined as “a person's sense of well-being that stems from satisfaction or dissatisfaction with the areas of life that are important.”
      • Padilla GV
      • Grant MM
      • Martin M
      Rehabilitation and quality of life measurement issues.
      The QOL of patients with maxillofacial defects is generally compromised even when a surgical reconstruction or prosthesis is provided.
      • Hecker DM
      • Wiens JP
      • Cowper TR
      • Eckert SE
      • Gitto CA
      • Jacob RF
      • et al.
      American Academy of Maxillofacial Prosthetics. Can we assess quality of life in patients with head and neck cancer? A preliminary report from the American Academy of Maxillofacial Prosthetics.
      • Irish J
      • Sandhu N
      • Simpson C
      • Wood R
      • Gilbert R
      • Gullane P
      • et al.
      Quality of life in patients with maxillectomy prostheses.
      • Katz MR
      • Irish JC
      • Devins GM
      • Rodin GM
      • Gullane PJ
      Psychosocial adjustment in head and neck cancer: the impact of disfigurement, gender and social support.
      These defects can be repaired with surgical techniques or prosthetic devices, depending on the site, size, age, etiology, severity, and patient preference.
      • Lundgren S
      • Moy PK
      • Beumer 3rd, J
      • Lewis S
      Surgical considerations for endosseous implants in the craniofacial region: a 3-year report.
      Surgical reconstruction may be limited by age, general medical condition of the patient, insufficient residual tissue, need to monitor tumor recurrence, vascular compromise subsequent to radiation, inadequacy of the donor sites, or patient preference. In these situations, prosthetic rehabilitation becomes the preferred treatment.
      • Reece GP
      • Lemon JC
      • Jacob RF
      • Taylor TD
      • Weber RS
      • Garden AS
      Total midface reconstruction after radical tumor resection: a case report and overview of the problem.
      • Hickey AJ
      • Salter M
      Prosthodontic and psychological factors in treating patients with congenital and craniofacial defects.
      Retention is the primary determinant in the success of a prosthetic restoration.
      • Abu-Serriah MM
      • McGowan DA
      • Moos KF
      • Bagg J
      Outcome of extra-oral craniofacial endosseous implants.
      The retention of maxillofacial prostheses has traditionally been provided with adhesives, anatomic undercuts, or connection to eyeglasses,
      • McKinstry RE
      but problems commonly encountered with these methods of retention have been reported.
      • Arcuri MR
      • LaVelle WE
      • Fyler A
      • Funk G
      Effects of implant anchorage on midface prostheses.
      • Visser A
      • Raghoebar GM
      • van Oort RP
      • Vissink A
      Fate of implant-retained craniofacial prostheses: life span and aftercare.
      • Udagama A
      • King GE
      Mechanically retained facial prostheses: helpful or harmful?.
      The use of craniofacial implants for the retention of extraoral prostheses enhances both retention and stability, improving the patient's confidence and sense of security.
      • Hooper SM
      • Westcott T
      • Evans PL
      • Bocca AP
      • Jagger DC
      Implant-supported facial prostheses provided by a maxillofacial unit in a U.K. regional hospital: longevity and patient opinions.
      • Kiat-amnuay S
      • Jacob RF
      • Chambers MS
      • Anderson JD
      • Sheppard RA
      • Johnston DA
      • et al.
      Clinical trial of chlorinated polyethylene for facial prosthetics.
      • Chang TL
      • Garrett N
      • Roumanas E
      • Beumer 3rd, J
      Treatment satisfaction with facial prostheses.
      • Markt JC
      • Lemon JC
      Extraoral maxillofacial prosthetic rehabilitation at the M. D. Anderson Cancer Center: a survey of patient attitudes and opinions.
      Despite the disadvantages of placing craniofacial implants for extraoral prosthetic rehabilitation, including the need for additional surgery, the challenge of proper implant positioning in patients with abnormal bone and soft tissue anatomy, and the healing time of the implants varying from 3 to 6 months, the use of implants does improve patient QOL by providing secure retention and stability, natural esthetics, and patient comfort. Thus, patients are able to function in society with more confidence because their defects are less noticeable.
      • Hooper SM
      • Westcott T
      • Evans PL
      • Bocca AP
      • Jagger DC
      Implant-supported facial prostheses provided by a maxillofacial unit in a U.K. regional hospital: longevity and patient opinions.
      • Anderson JD
      • Szalai JP
      The Toronto outcome measure for craniofacial prosthetics: a condition-specific quality-of-life instrument.
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      Earlier clinical studies on implant-retained maxillofacial prostheses focused on biological responses to the implants, with less regard for the impact of the prostheses on the patient's lifestyle or reintegration into society.
      • Lundgren S
      • Moy PK
      • Beumer 3rd, J
      • Lewis S
      Surgical considerations for endosseous implants in the craniofacial region: a 3-year report.
      • Abu-Serriah MM
      • McGowan DA
      • Moos KF
      • Bagg J
      Outcome of extra-oral craniofacial endosseous implants.
      • Arcuri MR
      • LaVelle WE
      • Fyler A
      • Funk G
      Effects of implant anchorage on midface prostheses.
      • Visser A
      • Raghoebar GM
      • van Oort RP
      • Vissink A
      Fate of implant-retained craniofacial prostheses: life span and aftercare.
      • Toljanic JA
      • Eckert SE
      • Roumanas E
      • Beumer J
      • Huryn JM
      • Zlotolow IM
      • et al.
      Osseointegrated craniofacial implants in the rehabilitation of orbital defects: an update of a retrospective experience in the United States.
      • Gary JJ
      • Donovan M
      Retention designs for bone-anchored facial prostheses.
      • Khamis MM
      • Medra A
      • Gauld J
      Clinical evaluation of a newly designed single-stage craniofacial implant: a pilot study.
      However, more recent studies have focused on evaluating the effect of maxillofacial implant treatment on QOL.
      • Hooper SM
      • Westcott T
      • Evans PL
      • Bocca AP
      • Jagger DC
      Implant-supported facial prostheses provided by a maxillofacial unit in a U.K. regional hospital: longevity and patient opinions.
      • Kiat-amnuay S
      • Jacob RF
      • Chambers MS
      • Anderson JD
      • Sheppard RA
      • Johnston DA
      • et al.
      Clinical trial of chlorinated polyethylene for facial prosthetics.
      • Chang TL
      • Garrett N
      • Roumanas E
      • Beumer 3rd, J
      Treatment satisfaction with facial prostheses.
      • Markt JC
      • Lemon JC
      Extraoral maxillofacial prosthetic rehabilitation at the M. D. Anderson Cancer Center: a survey of patient attitudes and opinions.
      • Anderson JD
      • Szalai JP
      The Toronto outcome measure for craniofacial prosthetics: a condition-specific quality-of-life instrument.
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      Currently, treatment strategies in every therapeutic intervention are concerned not only with survival statistics and biologic findings but also with the maintenance of QOL.
      • Bjordal K
      Impact of quality of life measurement in daily clinical practice.
      • Anderson JD
      The need for criteria on reporting treatment outcomes.
      After such an assessment, the clinician is able to inform patients about treatment outcomes and identify patients who may not be pleased with the proposed treatment objectives.
      • Hooper SM
      • Westcott T
      • Evans PL
      • Bocca AP
      • Jagger DC
      Implant-supported facial prostheses provided by a maxillofacial unit in a U.K. regional hospital: longevity and patient opinions.
      QOL instruments are generally standardized self-report questionnaires.
      • Bjordal K
      Impact of quality of life measurement in daily clinical practice.
      The questionnaires can be divided into 2 groups: general and specific. General or global instruments assess the overall impact of a patient's health status on QOL. One disadvantage is their lack of sensitivity in assessing the impact of various disease or treatment processes. Therefore, there is an apparent need to develop and use specific instruments for specific diseases, sites, and treatment situations in the assessment of QOL.
      • Bjordal K
      Impact of quality of life measurement in daily clinical practice.
      • Anderson JD
      The need for criteria on reporting treatment outcomes.
      The assessment of patient opinions on maxillofacial prostheses has been of interest to clinicians for many years.
      • Hickey AJ
      • Salter M
      Prosthodontic and psychological factors in treating patients with congenital and craniofacial defects.
      • Arcuri MR
      • LaVelle WE
      • Fyler A
      • Funk G
      Effects of implant anchorage on midface prostheses.
      • Hooper SM
      • Westcott T
      • Evans PL
      • Bocca AP
      • Jagger DC
      Implant-supported facial prostheses provided by a maxillofacial unit in a U.K. regional hospital: longevity and patient opinions.
      • Kiat-amnuay S
      • Jacob RF
      • Chambers MS
      • Anderson JD
      • Sheppard RA
      • Johnston DA
      • et al.
      Clinical trial of chlorinated polyethylene for facial prosthetics.
      • Chang TL
      • Garrett N
      • Roumanas E
      • Beumer 3rd, J
      Treatment satisfaction with facial prostheses.
      • Markt JC
      • Lemon JC
      Extraoral maxillofacial prosthetic rehabilitation at the M. D. Anderson Cancer Center: a survey of patient attitudes and opinions.
      • Anderson JD
      • Szalai JP
      The Toronto outcome measure for craniofacial prosthetics: a condition-specific quality-of-life instrument.
      • Jani RM
      • Schaaf NG
      An evaluation of facial prostheses.
      Jani and Schaaf
      • Jani RM
      • Schaaf NG
      An evaluation of facial prostheses.
      evaluated the opinions of 76 patients regarding their facial prostheses and reported retention problems and the rapid changes in color of adhesive-retained prostheses. Arcuri et al
      • Arcuri MR
      • LaVelle WE
      • Fyler A
      • Funk G
      Effects of implant anchorage on midface prostheses.
      reported improvement in QOL for patients with implant-retained midfacial prostheses. Chang et al
      • Chang TL
      • Garrett N
      • Roumanas E
      • Beumer 3rd, J
      Treatment satisfaction with facial prostheses.
      evaluated and compared patient satisfaction with adhesive-retained and implant-retained facial prostheses and indicated that implant-retained prostheses provided participants with improved treatment satisfaction. Leung and Cheung
      • Leung AC
      • Cheung LK
      Dental implants in reconstructed jaws: patients' evaluation of functional and quality-of-life outcomes.
      evaluated the functional and QOL outcomes of dental implants in reconstructed jaws by using a specifically developed questionnaire for Asian patients. The authors reported that jaw reconstruction with dental implants can provide a satisfactory level of esthetics, function, and well-being, thus improving QOL. In recent years, condition-specific QOL instruments with pilot-tested questionnaires have been developed
      • Anderson JD
      • Szalai JP
      The Toronto outcome measure for craniofacial prosthetics: a condition-specific quality-of-life instrument.
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      and used in clinical trials.
      • Kiat-amnuay S
      • Jacob RF
      • Chambers MS
      • Anderson JD
      • Sheppard RA
      • Johnston DA
      • et al.
      Clinical trial of chlorinated polyethylene for facial prosthetics.
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      These studies reveal that condition-specific instruments which are modified according to special populations should be used to measure QOL outcomes.
      The purpose of this study was to report the patient-based outcomes of implant-retained maxillofacial prostheses retrospectively and also to evaluate the effect of implant retention on the QOL of participants in a prospective study. The null hypotheses were that patient satisfaction with implant-retained maxillofacial prostheses would be similar to conventionally retained prostheses and that differences due to patient variables would not be observed in the retrospective group. In the prospective group, implant-retained maxillofacial prostheses would not increase patients’ QOL.

      Material and Methods

      The study population consisted of patients who were consecutively treated with implant-retained extraoral maxillofacial prostheses at the Faculty of Dentistry, Gazi University, Ankara, Turkey. The study protocol was approved by the Clinical Research Ethics Board of the Faculty. The data were divided into 2 groups, one for retrospective analysis (Retrospective Group) and the other for prospective analysis (Prospective Group). A flow chart of the study design is presented in Figure 1. The retrospective group consisted of patients who had been treated with implant-retained maxillofacial prostheses and who had participated in a regular supportive maintenance program from 2003 to 2009. The patients who attended recall examinations every 6 months were asked to participate in the study. The patients who did not return for follow-up were invited to participate in the study by telephone. No participants were excluded from the study based on gender, age, ethnic background, defect etiology and type, or number or type of implants placed. Patients who were lost to follow-up, refused to participate in the study, or whose poor health or psychological status did not allow cooperation were excluded from the study.
      The prospective group consisted of 28 participants who were willing to be treated with maxillofacial prostheses for the reconstruction of their defects. The study protocol was explained to the participants. Participants who had been irradiated with doses greater than 65 Gy, had significant systemic disease and were immunocompromised, were receiving chemotherapy, or refused to return for follow-up examinations were excluded from the study. Previously described surgical and prosthetic techniques were applied to the treatment sequence.
      • Lundgren S
      • Moy PK
      • Beumer 3rd, J
      • Lewis S
      Surgical considerations for endosseous implants in the craniofacial region: a 3-year report.
      • Karakoca S
      • Aydin C
      • Yilmaz H
      • Bal BT
      Survival rates and periimplant soft tissue evaluation of extraoral implants over a mean follow-up period of three years.
      Prosthetic retention was obtained with clips (Dolder bar and Dolder bar matrix; Institut Straumann AG, Basel, Switzerland) or magnets (EO Magnet; Institut Straumann AG) incorporated into the prostheses with corresponding abutment components attached to the implants.
      • Karakoca S
      • Aydin C
      • Yilmaz H
      • Bal BT
      Survival rates and periimplant soft tissue evaluation of extraoral implants over a mean follow-up period of three years.
      • Alvi R
      • McPhail J
      • Hancock K
      Closed-field titanium magnets for the retention of complex craniofacial prostheses.
      The prostheses were fabricated from silicone elastomer (Cosmesil; Principality Medical Ltd, Newport, UK) by using conventional techniques.
      • McKinstry RE
      • Taylor TD
      Replacement prostheses were provided when the life span of the prostheses ended; this was established according to previously reported criteria.
      • Karakoca S
      • Aydin C
      • Yilmaz H
      • Bal BT
      Retrospective study of treatment outcomes with implant-retained extraoral prostheses: survival rates and prosthetic complications.
      The prospective group was recruited before and after implant-retained prosthetic treatment between January 2007 and March 2009. Data were collected from the prospective group before implant placement and 6 months after the insertion of implant-retained prostheses to evaluate the changes in the QOL of the patients after implant-retained prosthetic treatment.
      In this study, the questionnaire developed by Sloan et al
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      to measure the QOL of patients with prosthetically reconstructed maxillofacial defects was administered with modifications. The original questionnaire was translated from English by 2 native Turkish speakers working in the clinical area, and the translations were reviewed by 2 bilingual clinicians. To determine whether the questionnaire was relevant to the Turkish patient population, the questionnaire was piloted by 12 patients attending regular follow-up visits. The benefits of developing specific national questionnaires for patients who have different cultural habits and beliefs have been reported previously.
      • Leung AC
      • Cheung LK
      Dental implants in reconstructed jaws: patients' evaluation of functional and quality-of-life outcomes.
      For this reason, the questionnaire was given with accompanying questions to determine whether the questions were clear, relevant to patient problems, or significant, and whether additional questions should be asked.
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      Another modification to the Sloan et al questionnaire
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      was made in the scoring of the responses. The authors used a 5-point visual analog scale (VAS), which had been validated in the psychometric literature.
      • Hyland ME
      • Sodergren SC
      Development of a new type of global quality of life scale, and comparison of performance and preference for 12 global scales.
      Proxy responses were also discussed. Therefore, in the present study, a 100-mm VAS was used to measure the satisfaction of the participants with their prostheses. Participants were asked to answer a question by marking an X on the 100-mm horizontal line at the point that best reflected their perceived experience. The line was anchored by words describing 2 extremes: 0 = completely dissatisfied and 100 = completely satisfied. A participant's score was obtained by measuring the distance, in millimeters, between the zero and the X. The responses were recorded by a prosthodontist who did not participate in the fabrication of the prostheses.
      In the study, the retrospective group participants were asked to complete a questionnaire at the last follow-up visit (between 32 months and 78 months after treatment), and the prospective group participants were asked before implant placement and 6 months after insertion of the implant-retained prostheses. All participants signed a written informed consent releasing their data for scientific purposes. The questions were provided to the participants in written form.
      In the statistical analyses of patient satisfaction with implant-retained prostheses, posttreatment results of retrospective and prospective groups were evaluated together. The Levene and Kolmogorov-Simirnov tests were used to determine the homogeneity and normality of data, respectively. The patient satisfaction scores for each question were statistically analyzed by 2-way analysis of variance (ANOVA) with defect type and retention type as variables. The Student-Newman-Keuls test was used to determine any significant differences between the groups. In the prospective group, the mean scores before and after implant-retained prostheses were compared by using the paired t test. Statistical analyses were performed with software (SPSS v18 for Windows statistical software package; SPSS, Inc, Chicago, Ill). The overall α was set at .05.

      Results

      The details of 97 participants (54 in the retrospective and 28 in the prospective group) were reviewed. In data collection for the retrospective group, 15 participants were excluded from the evaluation; 4 participants could not be reached by telephone; 3 participants died; and 8 participants did not agree to attend the study. This group included 54 participants (29 men, 25 women) with an age range of 15 to 77 (mean 43.8) years. The population consisted of 20 participants with auricular defects, 26 with orbital defects, and 8 with nasal defects. Two of the participants with auricular defects had bilateral defects. The follow-up period was between 32 and 78 (mean 45.9) months.
      The prospective group included 28 participants (18 men, 10 women) with an age range of 14 to 75 (mean 44.9) years. The population consisted of 12 participants with auricular defects, 10 with orbital defects, and 6 with nasal defects. All participants in the prospective group returned for 6-month recall examinations. Participant characteristics are documented in Table I.
      Table IParticipant characteristics
      Prospective Group (n=28)Retrospective Group (n=54)
      Implant site12 auricular20 auricular
      10 orbital26 orbital
      6 nasal8 nasal
      Age range/Mean age(years)14 – 75/Mean age 44.915 – 77/Mean 43.8
      Gender18 male29 male
      10 female25 female
      Defect etiology7 congenital9 congenital
      4 trauma6 trauma
      17 oncology35 oncology
      4 burn
      Follow-up period/mean (months)6 months32 – 78/Mean 45.9 months
      Retention type15 bar-clips26 bar-clips
      13 magnet28 magnet
      Defect site situation before implant-retained prostheses3 conventional retained prostheses5 conventional retained prostheses
      21 covered with bandage44 covered with bandage
      5 exposed defect/hidden by hair
      Number of implant-retained prostheses28 first prosthesis2 first prosthesis
      15 second prosthesis
      26 third prosthesis
      11 fourth prosthesis
      The questionnaire pilot test revealed that there were no confusing or unclear questions. Results of the pilot test also confirmed that the items were relevant to the situation of the participants. Five participants indicated they had undergone this treatment on the recommendation of another person. Therefore, considering the recommendations of existing prostheses users would be meaningful. Also, 7 participants reported they generally needed to cover the defect side with hair or eyeglasses, even though they had esthetically pleasing prostheses. These 2 concerns, which were frequently indicated by the pilot test group, were added to the original questionnaire developed by Sloan et al.
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      There were no missing data on either the retrospective or the prospective group questionnaires. For the posttreatment data, descriptive statistics are given and statistical differences are shown in Table II. The 2-way ANOVA showed that there were interactions with the variables defect type and retention type for cleaning the prostheses (P<.03). Statistical significance was found in the variable defect type for the question about recommending treatment to other people (P<.01). No interaction was found for other questionnaire items (P>.05). For cleaning the prostheses, the degree of satisfaction with auricular and nasal prostheses was significantly greater than with bar-clip-retained orbital prostheses. The participants who used auricular and nasal prostheses retained by both bar-clips and magnets expressed significantly higher satisfaction than patients with orbital prostheses and recommended treatment to other people. Participant perceptions of appearance, retention, conspicuousness, self-consciousness, placement, removal, limiting activities, tissue discomfort, and the need for covering the defect side did not differ significantly by defect or retention type. The use of an adhesive-retained prosthesis before implant retention was not comparable because of the small sample size. In the prospective group, the participants reported statistically significant increases in satisfaction for all questions (Table III).
      Table IIParticipant evaluation results for each question with defect type and retention type as vari­ables. In each cell of table, first line indicates mean ± standard error and number of participants. Second line indicates median (minimum-maximum).
      Retention TypeDefect Type
      NasalOrbitalAuricularTotal
      Comfort with appearanceBar-clips64.9 ± 4.8 n=866 ± 7.2 n=377.7 ± 1.8 n=3074.3 ± 1.9 n=41
      60 (49 – 83)65 (54 – 79)79 (50 – 95)77 (49 – 95)
      Magnet70.7 ± 5.9 n=670.5 ± 1.8 n=3369 ± 2 n=270.4 ± 1.7 n=41
      68 (55 – 88)70 (52 – 90)69 (67 – 71)70 (52 – 90)
      Total67.4 ± 3.7 n=1470.1 ± 1.7 n=3677.1 ± 1.7 n=32
      60 (49 – 88)70 (52 – 90)78 (50 – 95)
      Quality of retentionBar-clips74 ± 4.1 n=879 ± 2.1 n=379.70 ± 1.8 n=3078.5 ± 1.5 n=41
      72.5 (55 – 93)80 (75 – 82)50 (79.5 – 100)78 (50 – 100)
      Magnet76.7 ± 4.9 n=673.7 ± 1.7 n=3371.5 ± 4.5 n=273.7 ± 1.5 n=41
      80 (56 – 88)75 (55-92)71.5 (67 – 76)55 (76 – 92)
      Total75.1 ± 3.04 n=1473.8 ± 1.6 n=3679.2 ± 1.7 n=32
      75.5 (55 – 93)55 (75.5 – 92)78.5 (50 – 100)
      ConspicuousnessBar-clips65.9 ± 5.6 n=860 ± 8.7 n=373.6 ± 3.1 n=3071.1 ± 2.6 n=41
      65 (45 – 91)60 (45 – 75)79.5 (0 – 90)76 (0 – 91)
      Magnet67 ± 7 n=665.2 ± 2.3 n=3360 ± 7 n=265.2 ± 2.1 n=41
      54 (57 – 91)67 (39 – 90)53 (60 – 67)39 (66 – 91)
      Total66.4 ± 4.2 n=1464.7 ± 2.2 n=3672.7 ± 3 n=32
      59 (45 – 91)39 (66.5 – 90)78 (0 – 90)
      Self-consciousnessBar-clips61.9 ± 4.1 n=860 ± 1.76 n=370.90 ± 2.47 n=3068.4 ± 2.1 n=41
      62 (39 – 76)61 (57 – 63)74 (40 – 90)70 (39 – 90)
      Magnet63.5 ± 5.8 n=659.4 ± 1.9 n=3354.5 ± 7.5 n=259.8 ± 1.8 n=41
      50 (57.5 – 86)59 (43 – 85)54.5 (47 – 62)59 (43 – 86)
      Total62.6 ± 3.3 n=1459.5 ± 1.8 n=3669.9 ± 2.44 n=32
      60 (39 – 86)59 (43 – 85)74 (40 – 90)
      Difficulty in placingBar-clips73 ± 2 n=861.7 ± 7.3 n=375.4 ± 1.7 n=3073.9 ± 1.5 n=41
      73.5 (64 – 82)50 (60 – 75)76.5 (60 – 91)75 (50 – 91)
      Magnet71 ± 4.7 n=667.9 ± 2.1 n=3375.5 ± 12.5 n=268.7 ± 1.9 n=41
      72.5 (56 – 85)70 (34 – 85)75.5 (63 – 88)70 (34 – 88)
      Total72.1 ± 2.2 n=1467.4 ± 2 n=3675.4 ± 1.7 n=32
      73.5 (56 – 85)69 (34 – 85)76.5 (60 – 91)
      Difficulty in removingBar-clips70.3 ± 4.58 n=862.7 ± 8.8 n=378.8 ± 1.6 n=3075.9 ± 1.7 n=41
      74.5 (53 – 88)57 (51 – 80)81 (60 – 90)76 (51-90)
      Magnet76.7 ± 5.2 n=670.2 ± 2 n=3364.5 ± 7.5 n=270.8 ± 1.8 n=41
      77.5 (55 – 91)70 (45 – 89)64.5 (57 – 72)72 (45 – 91)
      Total73 ± 3.4 n=1469.5 ± 1.9 n=3677.9 ± 1.7 n=32
      75.5 (53 – 91)68.5 (45 – 89)79.5 (57 – 90)
      Difficulty in cleaningBar-clips69.4 ± 3.3Aa n=856.7 ± 8.4Ab n=376 ± 1.6Aa n=3073.3 ± 1.6 n=41
      67 (58 – 84)52 (45 – 73)75.5 (55 – 97)75 (45 – 97)
      Magnet76.7 ± 2.9Aa n=667.9 ± 2.1Aa n=3362.5 ± 7Ba n=268.9 ± 1.8 n=41
      75.5 (68 – 87)69 (33 – 85)62.5 (55 – 70)70 (33 – 87)
      Total72.5 ± 2.4 n=1467 ± 2 n=3675.2 ± 1.6 n=32
      72.5 (58 – 87)69 (33 – 85)75 (55 – 97)
      Limitation of activitiesBar-clips66.4 ± 3.9 n=864.3 ± 12.8 n=374.8 ± 1.9 n=3072.4 ± 1.8 n=41
      50 (67 – 80)67 (41 – 85)75 (54 – 96)74 (41 – 96)
      Magnet67.7 ± 6.4 n=666.9 ± 2.4 n=3365 ± 4 n=266.9 ± 2.1 n=41
      71 (45 – 86)37 (70 – 89)65 (61 – 69)69 (37 – 89)
      Total66.9 ± 3.4 n=1466.7 ± 2.4 n=3674.2 ± 1.8 n=32
      70.5 (45 – 86)69.5 (37 – 89)74.5 (54 – 96)
      Discomfort of tissuesBar-clips68.9 ± 3.8 n=868.7 ± 7.5 n=377.7 ± 1.7 n=3075.3 ± 1.6 n=41
      73.5 (49 – 78)55 (70 – 81)76.5 (60 – 95)76 (49 – 95)
      Magnet66.4 ± 6 n=669.8 ± 1.7 n=3359.5 ± 0.5 n=268.8 ± 1.7 n=41
      66 (45 – 90)70 (42 – 87)59 (59 – 60)69 (42 – 90)
      Total67.8 ± 3.2 n=1469.7 ± 1.7 n=3676.5 ± 1.8 n=32
      69.5 (45 – 90)70 (42 – 87)76 (59 – 95)
      Need for covering defect side with hair or eyeglassesBar-clips67.1 ± 5 n=867 ± 6.8 n=373.7 ± 2.1 n=3071.9 ± 1.9 n=41
      71 (43 – 84)70 (54 – 77)78.5 (50 – 91)76 (43 – 91)
      Magnet71.5 ± 4.2 n=667 ± 2.1 n=3367.5 ± 10.5 n=267.7 ± 1.8 n=41
      75 (53 – 80)67 (40 – 87)67.5 (57 – 78)68 (40 – 87)
      Total69 ± 3.3 n=1467 ± 2 n=3673.3 ± 2 n=32
      73.5 (43 – 84)67.5 (40 – 87)78 (50 – 91)
      Recommending treatment to other peopleBar-clips83.4 ± 3.7 n=859.7 ± 8 n=381.7 ± 2.4 n=3080.4 ± 2.1 n=41
      83.5 (65 – 96)65 (44 – 70)81 (50 – 100)80 (44 – 100)
      Magnet83.2 ± 5.9 n=674.6 ± 2.11 n=3375 ± 5 n=2 7575.5 ± 1.9 n=41
      87.5 (56 – 96)71 (50 – 100)(70 – 80)73 (50 – 100)
      Total83.3 ± 3.1 * n=1472.9 ± 2.1 # n=3681.3 ± 2.2 * n=32
      86 (56 – 96)70.5 (44 – 100)80 (50 – 100)
      Same uppercase letters within defect type (vertically) indicate that patient perceptions were not statistically significantly different among retentive attachment types (P>.05).
      Same lowercase letters within retentive attachment types (horizontally) indicate that patient perceptions were not statistically significantly different among defect types (P>.05).
      Same symbols (*, #) indicate that patient perceptions were not statistically significantly different among defect types (P>.05).
      Table IIIChanges in mean scores after implant-retained maxillofacial prosthetic rehabilitation
      Prospective Group (n=28)
      Participants' perceptionPretreatment (with covering or conventional prostheses)Posttreatment (with implant-retained prostheses)Mean of Individual DifferencesP
      Comfort with appearance32.4 (10.8)68.9 (11.9)43.1 (15.1)<.001
      Quality of retention42.8 (15.7)75.4 (9.9)32.2 (18.5)<.001
      Noticeability31.8 (9.3)70.5 (13.7)38.7 (15.6)<.001
      Self-consciousness40.2 (17.2)64 (11.7)27.5 (12.2)<.001
      Difficulty in placing31.4 (11.7)70.1 (12)40.3 (13.4)<.001
      Difficulty in removing36.1 (13.6)73.3 (13.2)37.2 (17.5)<.001
      Difficulty in cleaning33.3 (7.4)68.9 (13.4)35.6 (15.4)<.001
      Limitation of activities41.1 (17.1)70.3 (13.1)29.8 (16.6)<.001
      Discomfort of tissues29.1 (6.5)71.9 (10.8)42.6 (12.7)<.001
      Need for covering defect side with hair, eyeglasses30.2 (11)72 (11.9)41.2 (15.1)<.001
      Statistically significantly different between groups (P<.05)

      Discussion

      The data from this study led to rejection of the null hypotheses of the research, that in the posttreatment evaluation of retrospective and prospective groups, patient satisfaction with implant-retained maxillofacial prostheses differed significantly for cleaning the prostheses and recommending treatment to other people, depending on the defect type and retentive attachment type. In the prospective group, implant-retained maxillofacial prostheses increased participants’ QOL significantly for all aspects of the questionnaire.
      For QOL measurements, investigators may use existing questionnaires or may develop their own validated, reliable, and sensitive QOL questionnaire for use with a specific patient group.
      • Padilla GV
      • Grant MM
      • Martin M
      Rehabilitation and quality of life measurement issues.
      The American Academy of Maxillofacial Prosthetics has stated that an ideal questionnaire to measure QOL would include simple, direct questions and that completing multiple questionnaires with several items could be cumbersome and fatiguing for patients.
      • Hecker DM
      • Wiens JP
      • Cowper TR
      • Eckert SE
      • Gitto CA
      • Jacob RF
      • et al.
      American Academy of Maxillofacial Prosthetics. Can we assess quality of life in patients with head and neck cancer? A preliminary report from the American Academy of Maxillofacial Prosthetics.
      However, the probability of missing details should be considered in this approach.
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      In the present study, the QOL questionnaire developed for a similar patient group by Sloan et al
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      was used. Sloan et al developed the current brief, specific, and validated questionnaire for participants with craniofacial implants and prostheses and used single items rather than scales and multiple items. Regarding benefits and shortcomings, the instrument developed by Sloan et al
      • Sloan JA
      • Tolman DE
      • Anderson JD
      • Sugar AW
      • Wolfaardt JF
      • Novotny P
      Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
      was selected to reveal the clinical effects of implant-retained maxillofacial prostheses on the QOL of patients. QOL instruments addressing multiple domains with several questionnaire items have been used to investigate the outcomes of new treatment approaches or materials as reported by Kiat-amnuay et al
      • Kiat-amnuay S
      • Jacob RF
      • Chambers MS
      • Anderson JD
      • Sheppard RA
      • Johnston DA
      • et al.
      Clinical trial of chlorinated polyethylene for facial prosthetics.
      to compare chlorinated polyethylene material with silicone elastomers.
      For the variables defect and retention type, significant differences in participant perception were found for cleaning the prostheses and recommending treatment to other people. The participants who used orbital prostheses retained with bar-clips reported the lowest satisfaction with cleaning the prostheses (Table II). These patients also reported the lowest satisfaction with placing and removing the prosthesis, although the scores were not statistically different from those of patients with nasal and auricular defects. Monocular vision and its associated decrease in depth perception in these participants can cause difficulties with placing, removing, and cleaning the prosthesis and defect site. In the authors’ experience, fabricating an esthetically pleasing orbital prosthesis that symmetrically matches the position of the eye, lid contour, and skin color of the nondefect site is a challenge.
      • McKinstry RE
      • Taylor TD
      However, the ocular component of the orbital prosthesis is immobile and palpebral movement is impossible. The dynamic movement of the remaining eye and the adjacent orbital structure asymmetry increase the level of difficulty in creating a natural-looking orbital prosthesis.
      • Chang TL
      • Garrett N
      • Roumanas E
      • Beumer 3rd, J
      Treatment satisfaction with facial prostheses.
      Thus, it would be expected that participants’ discomfort with their appearance might cause self-consciousness.
      Participants treated with auricular prostheses reported a higher degree of comfort of the tissues beneath the prostheses, although the scores were not statistically different from patients with nasal and orbital defects. Clinical experience shows that providing thin and immobile soft tissues around the implants and beneath the prostheses is possible in the auricular region. Auricular prosthetic design also includes a posterior vent space to allow for aeration. These characteristics of the auricular region may have resulted in patients’ increased comfort with the prostheses. In contrast, the blind duct characteristics of an orbital defect and the margin sealing of the prostheses increase entrapment of moisture behind the prosthesis; therefore, the participants may have reported lower scores for comfort of the tissues. For the nasal defects, tissues around the implants and the underlying prosthesis were generally thick, mobile, and moist because of nasal secretions, which may cause discomfort. Participants with auricular and nasal prostheses recommended the treatment to others more than participants with orbital prostheses.
      Of the 2 different prosthetic retentive designs for maxillofacial prostheses, patient satisfaction scores in the present study were significantly higher for magnet retention in patients with orbital prostheses. In the field of implant-retained maxillofacial prostheses, the convenient bar-clip systems have been well-known and extensively used for many years.
      • Gary JJ
      • Donovan M
      Retention designs for bone-anchored facial prostheses.
      • Taylor TD
      Recently, the hygienic, mechanical, and esthetic advantages of magnets have been emphasized for the retention of facial prostheses.
      • Gary JJ
      • Donovan M
      Retention designs for bone-anchored facial prostheses.
      • Alvi R
      • McPhail J
      • Hancock K
      Closed-field titanium magnets for the retention of complex craniofacial prostheses.
      Despite these advantages, clinical experience has shown that patients may be more satisfied with the superior retentive capacity of the bar-clip system than with magnetic attachments.
      In retrospective studies, the absence of suitable controls is one of the main problems weakening the results of the study.
      • Anderson JD
      The need for criteria on reporting treatment outcomes.
      Therefore, a prospective group was created to evaluate the pretreatment QOL of the participants as well as retrospectively evaluating patients who had been under care for many years. In the prospective group, the average score changes between the baseline and 6 months after prosthesis insertion were found to be significantly different for each questionnaire item. The criteria for participation in the present study did not include having a conventionally retained prosthesis experience. If such a prospective group could be obtained, the effect of implant retention in comparison with adhesive or mechanical retention methods could also be investigated. Chang et al
      • Chang TL
      • Garrett N
      • Roumanas E
      • Beumer 3rd, J
      Treatment satisfaction with facial prostheses.
      reported significant improvements in patient satisfaction with implant-retained maxillofacial prostheses compared with adhesive-retained prostheses. Another report comparing mid-facial prostheses before and after implant retention revealed that implants not only improved retention but also had positive effects on patient satisfaction with appearance, ease of use, and self-consciousness.
      • Arcuri MR
      • LaVelle WE
      • Fyler A
      • Funk G
      Effects of implant anchorage on midface prostheses.
      A limitation of the present study is that participants who failed to return for follow-up examinations or refused to fill out the questionnaire were excluded, and thus bias the data. Besides the questionnaire items, the authors recognized that the context in which the defect and maxillofacial prosthetic reconstruction occurred was also a powerful determinant of QOL. Being employed and having a certain level of education, family support, and social interests increased patient QOL.

      Conclusions

      Implant-retained prostheses were considered highly satisfactory, indicating good QOL for patients with maxillofacial defects. The results of this study combined with previous studies can be used to better inform those who would undergo maxillofacial prosthetic treatment about the expected outcome. A comparison of pretreatment and posttreatment assessments revealed implant-retained maxillofacial prostheses increased patients’ QOL.

      References

        • Padilla GV
        • Grant MM
        • Martin M
        Rehabilitation and quality of life measurement issues.
        Head Neck Surg. 1988; 10: S156-S160
        • Hecker DM
        • Wiens JP
        • Cowper TR
        • Eckert SE
        • Gitto CA
        • Jacob RF
        • et al.
        American Academy of Maxillofacial Prosthetics. Can we assess quality of life in patients with head and neck cancer? A preliminary report from the American Academy of Maxillofacial Prosthetics.
        J Prosthet Dent. 2002; 88: 344-351
        • Irish J
        • Sandhu N
        • Simpson C
        • Wood R
        • Gilbert R
        • Gullane P
        • et al.
        Quality of life in patients with maxillectomy prostheses.
        Head Neck. 2009; 31: 813-821
        • Katz MR
        • Irish JC
        • Devins GM
        • Rodin GM
        • Gullane PJ
        Psychosocial adjustment in head and neck cancer: the impact of disfigurement, gender and social support.
        Head Neck. 2003; 25: 103-112
        • Lundgren S
        • Moy PK
        • Beumer 3rd, J
        • Lewis S
        Surgical considerations for endosseous implants in the craniofacial region: a 3-year report.
        Int J Oral Maxillofac Surg. 1993; 22: 272-277
        • Reece GP
        • Lemon JC
        • Jacob RF
        • Taylor TD
        • Weber RS
        • Garden AS
        Total midface reconstruction after radical tumor resection: a case report and overview of the problem.
        Ann Plast Surg. 1996; 36: 551-557
        • Hickey AJ
        • Salter M
        Prosthodontic and psychological factors in treating patients with congenital and craniofacial defects.
        J Prosthet Dent. 2006; 95: 392-396
        • Abu-Serriah MM
        • McGowan DA
        • Moos KF
        • Bagg J
        Outcome of extra-oral craniofacial endosseous implants.
        Br J Oral Maxillofac Surg. 2001; 39: 269-275
        • McKinstry RE
        Fundamentals of facial prosthetics. ABI Professional Publications, Arlington1995: 137-146
        • Arcuri MR
        • LaVelle WE
        • Fyler A
        • Funk G
        Effects of implant anchorage on midface prostheses.
        J Prosthet Dent. 1997; 78: 496-500
        • Visser A
        • Raghoebar GM
        • van Oort RP
        • Vissink A
        Fate of implant-retained craniofacial prostheses: life span and aftercare.
        Int J Oral Maxillofac Implants. 2008; 23: 89-98
        • Udagama A
        • King GE
        Mechanically retained facial prostheses: helpful or harmful?.
        J Prosthet Dent. 1983; 49: 85-86
        • Hooper SM
        • Westcott T
        • Evans PL
        • Bocca AP
        • Jagger DC
        Implant-supported facial prostheses provided by a maxillofacial unit in a U.K. regional hospital: longevity and patient opinions.
        J Prosthodont. 2005; 14: 32-38
        • Kiat-amnuay S
        • Jacob RF
        • Chambers MS
        • Anderson JD
        • Sheppard RA
        • Johnston DA
        • et al.
        Clinical trial of chlorinated polyethylene for facial prosthetics.
        Int J Prosthodont. 2010; 23: 263-270
        • Chang TL
        • Garrett N
        • Roumanas E
        • Beumer 3rd, J
        Treatment satisfaction with facial prostheses.
        J Prosthet Dent. 2005; 94: 275-280
        • Markt JC
        • Lemon JC
        Extraoral maxillofacial prosthetic rehabilitation at the M. D. Anderson Cancer Center: a survey of patient attitudes and opinions.
        J Prosthet Dent. 2001; 85: 608-613
        • Anderson JD
        • Szalai JP
        The Toronto outcome measure for craniofacial prosthetics: a condition-specific quality-of-life instrument.
        Int J Oral Maxillofac Implants. 2003; 18: 531-538
        • Sloan JA
        • Tolman DE
        • Anderson JD
        • Sugar AW
        • Wolfaardt JF
        • Novotny P
        Patients with reconstruction of craniofacial or intraoral defects: development of instruments to measure quality of life.
        Int J Oral Maxillofac Implants. 2001; 16: 225-245
        • Toljanic JA
        • Eckert SE
        • Roumanas E
        • Beumer J
        • Huryn JM
        • Zlotolow IM
        • et al.
        Osseointegrated craniofacial implants in the rehabilitation of orbital defects: an update of a retrospective experience in the United States.
        J Prosthet Dent. 2005; 94: 177-182
        • Gary JJ
        • Donovan M
        Retention designs for bone-anchored facial prostheses.
        J Prosthet Dent. 1993; 70: 329-332
        • Khamis MM
        • Medra A
        • Gauld J
        Clinical evaluation of a newly designed single-stage craniofacial implant: a pilot study.
        J Prosthet Dent. 2008; 100: 375-383
        • Bjordal K
        Impact of quality of life measurement in daily clinical practice.
        Ann Oncol. 2004; 15: 279-282
        • Anderson JD
        The need for criteria on reporting treatment outcomes.
        J Prosthet Dent. 1998; 79: 49-55
        • Jani RM
        • Schaaf NG
        An evaluation of facial prostheses.
        J Prosthet Dent. 1978; 39: 546-550
        • Leung AC
        • Cheung LK
        Dental implants in reconstructed jaws: patients' evaluation of functional and quality-of-life outcomes.
        Int J Oral Maxillofac Implants. 2003; 18: 127-134
        • Karakoca S
        • Aydin C
        • Yilmaz H
        • Bal BT
        Survival rates and periimplant soft tissue evaluation of extraoral implants over a mean follow-up period of three years.
        J Prosthet Dent. 2008; 100: 458-464
        • Alvi R
        • McPhail J
        • Hancock K
        Closed-field titanium magnets for the retention of complex craniofacial prostheses.
        Br J Plast Surg. 2002; 55: 668-670
        • Taylor TD
        Clinical maxillofacial prosthetics. Quintessence, Chicago2000: 233-244
        • Karakoca S
        • Aydin C
        • Yilmaz H
        • Bal BT
        Retrospective study of treatment outcomes with implant-retained extraoral prostheses: survival rates and prosthetic complications.
        J Prosthet Dent. 2010; 103: 118-126
        • Hyland ME
        • Sodergren SC
        Development of a new type of global quality of life scale, and comparison of performance and preference for 12 global scales.
        Qual Life Res. 1996; 5: 469-480