JOMI on CD-ROM, 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E

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Craniofacial Osseointegration: The Canadian Experience

John F. Wolfaardt, BDS, MDent, PhD/Gordon H. Wilkes, MD, FRCS(C)/Stephen M. Parel, DDS/Anders Tjellstrm, MD, PhD

A survey was undertaken to determine the number of centers in Canada with an active involvement in extraoral osseointegration. It was found that six centers had placed 222 implants in 91 patients in Canada. The individual implant success rates for the Canadian experience were compared with the published Swedish and United States' experience. The Canadian experience is combined with the Swedish and United States' experience to provide retrospective multinational multicenter data. The data given should be viewed as providing trends only and not as definitive expectations of predictable success rates. The success rates are considered likely to change with time as the number of patients treated increases and the duration of follow-up is extended. The mastoid region in nonradiated patients is considered to provide a high degree of predictable individual implant success. The success rates in radiated patients yield far lower success rates, which vary with anatomic location. The criteria for success in using craniofacial implants need to be defined and should reflect the differences between extraoral and intraoral implants. (INT J ORAL M AXILLOFAC IMPLANTS 1993;8:197204.)
Key words: craniofacial implants, criteria for success, extraoral implants, multicenter study, multinational study, radiation therapy

Factors influencing the success or failure of a facial prosthesis are numerous. For a
facial prosthesis to be successful it must meet criteria of esthetic acceptability, functional performance, biocompatibility, and desired retention.1 Providing adequate retention has been a constant challenge with many facial prostheses. Inherent mechanical retention within the defect or the use of adhesive systems have frequently proven to be problematic or unacceptable.2-10 With the introduction of osseointegration to the extraoral craniofacial complex, predictable mechanical retention of facial prostheses was established. In addition to providing predictable retention, several other important advantages have been achieved. Esthetics and durability of prostheses have been enhanced because fine feathered margins are maintainable and not liable to damage by adhesives and solvents. Skin and mucosal surfaces are subject to less mechanical and chemical insult from intrinsic mechanical retention, adhesives, and adhesive solvents. Clinical experience has shown that craniofacial osseointegration changes the patient's perceptions of a facial prosthesis ( Figs 1 to 4). The prosthesis is no longer seen as a foreign object about the head and

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neck. With the implant-supported and -retained prosthesis, the patient appears to recognize the prosthesis as self. A further extension of this biotechnology has been to use the implants to retain hearing aids. An implant is placed into the mastoid region, and once osseointegration has been established a hearing aid can be attached to provide bone conduction hearing (Figs 5 to 7). Craniofacial osseointegration biotechnology provides patients with congenital or acquired deformities an opportunity to be treated conveniently and with a predictable retention base for a variety of prosthetic devices.11 The application of craniofacial osseointegration biotechnology to facial reconstruction was first reported in 1977, when an implant fixture was placed into the cranial skeleton to retain a bone-anchored hearing aid.6 In 1979, the first implants were placed to retain an auricular prosthesis. In May 1984, the biotechnology was released internationally with the introduction of training courses in Gteborg, Sweden. In 1991, Parel and Tjellstrm11 presented the results of the Swedish and United States' experience with extraoral osseointegration. The present report provides a survey of the Canadian experience with craniofacial osseointegration. The results gathered in the present survey are added to those of the Swedish and United States report to provide broader multinational data.

Swedish and United States' Experience

A study of experience with craniofacial implants was conducted by Parel and Tjellstrm11 and involved the work of 1 Swedish and 13 United States centers. These authors investigated the number of implants placed into patients who had and had not received radiotherapy. While no experience with bone-anchored hearing aids was reported from the United States, the Swedish experience was included. The results of the Swedish and United States centers have been combined (Tables 1 to 3). Several facts emerging from Parel and Tjellstrm's study are important. The study indicates that implant placement in the mastoid region carries a high success rate based on individual implant stability with a combined center success rate of 98.3% in nonradiated patients. Orbital implants in this category of patients provides an equally impressive combined success rate of 93.9%. Success rates in the midface and in radiated patients proved more variable. The combined center individual implant success rate for radiated patients was 61.1%. In some anatomic locations, the number of patients treated was too small to draw firm conclusions. Parel and Tjellstrm found in this early evaluation that the nonradiated patient could be effectively treated with osseointegrated implants to retain a facial prosthesis in various areas of the facial skeleton. These workers concluded that the irradiated patient should be approached with care and in an environment that fully appreciated the risks associated with external beam therapy.

Materials and Methods

All centers in Canada likely to be involved with craniofacial osseointegration were

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contacted. Each center was asked to supply information in the form reported by Parel and Tjellstrm11 and to indicate the date of initiation of extraoral implant services to patients. The following information for radiated and nonradiated patients was requested: number of implants placed, number of implants integrated, number of implants lost early (less than 1 year after placement), and number of implants lost late (more than 1 year after placement). This information was requested for the orbital, mastoid, and nasal regions. Implants placed outside these regions were grouped under a separate but collective category. Implants placed in the mastoid region for attachment of bone-anchored hearing aids were included in a separate category. The only criterion for success applied in the present study is that at the time of data gathering the implant was considered integrated.

Results
Of eight centers contacted, six responded as having placed extraoral implants. The respondents and the centers identified are provided in Table 4. It was found that the Canadian experience with craniofacial osseointegration varies between 12 and 48 months (Table 4). In the case of implants used to retain facial prostheses, all were of the Brnemark 3.00-mm and 4.00-mm extraoral fixture type (Nobelpharma AB, Gteborg, Sweden). With the implants used to retain bone-anchored hearing aids, the implants were found to be of the Brnemark type in some cases and of the Xomed Audiant type (Xomed-Surgitek, Mississauga, Ontario, Canada) in others. Nonradiated Patients (Table 5). It was found that 41 patients had been treated with extraoral implants to retain facial prostheses. All of the 138 fixtures placed were of the Brnemark type and of these 2 were lost early and 1 late, yielding a 97.8% overall individual implant success rate. The orbit produced a slightly lower success rate (96.6%) than the mastoid region (98.9%). The nasal region had a success rate of 80.0%, which was markedly lower than the mastoid and orbital regions, but the number of implants placed in this region is too low to draw any conclusions. Bone-Anchored Hearing Aid Patients (Table 7). Implants placed into the mastoid region to retain bone anchored-hearing aids (BAHA) had been used in 46 patients. Of the 48 implants placed, 1 fixture was lost early. Twenty-four of the implants were of the Xomed Audiant type and the remaining 24 were of the Brnemark extraoral type. Placement of fixtures into the mastoid region to retain a BAHA produced an overall individual implant success rate of 97.9%. Radiated Patients (Table 6). All of the 7 patients reported had received a dosage of 4,000 to 7,000 rads and 3 had been treated with hyperbaric oxygen. The 7 patients received a total of 36 implants in 8 operative sites; 2 implants were lost early, producing an overall success rate of 94.4%. Twenty-eight implants were placed into 6 orbital operative sites with 1 early fixture loss. The success rate in the orbit was 96.4% . The nasal and other sites had too few implants placed to draw any conclusions.

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Total Canadian Experience (Table 8). The total Canadian experience involved the placement of 222 extraoral implants in 91 patients. Of the 222 implants placed, 198 were of the Brnemark extraoral type and the remainder were of the Xomed Audiant variety. A total of 216 implants was considered to have integrated, providing an overall success rate of 97.3%. Of the 6 implants that failed to integrate, 5 were lost early (less than 1 year after insertion) and 1 was a late loss (more than 1 year after insertion).

Combined Result of Canadian, Swedish, and United States' Experience

The combined results show that the treatment of 603 nonradiated patients has been reported (Table 9). In this patient group, 1,221 extraoral implants have been placed and 1,190 have been regarded as stable at the time of reporting, thereby providing an individual implant success rate of 97.5%. Of importance is that the experience in all three countries provides similar rates of individual implant success. A much smaller group of radiated patients has been treated, with 34 patients being reported. In this group, 144 implants were placed and 100 of these have successfully integrated, for a success rate of 69.4% . In the radiated group of patients, the success rate is highest in Canada, and this declines respectively in the United States and then Sweden. These difference are thought to be a function of time of follow-up, number of patients treated, and distribution of case type treated. As each of these factors increases, it appears that the success rate can be expected to decline toward an as yet unestablished baseline for radiated patients. The total combined Canadian, Swedish, and United States' experience indicated that 637 patients have had 1,365 extraoral implants placed and that 1,290 implants have integrated, providing an overall success rate of 95.1%. Of the 1,290 implants reported as integrated, 1,266 were of the Brnemark type and 24 were of the Xomed Audiant type.

Discussion
Craniofacial osseointegrated implants offer patients who wear facial prostheses a significantly improved quality of life. As the international experience with this treatment modality progresses, it is important that treatment outcomes be documented and reported. In the case of the intraoral experience with osseointegrated implants, the level of documentation of treatment outcome has continued to evolve, with intracenter, national, and international prospective studies becoming the norm. It is in this direction that future reporting of extraoral implant treatment outcome reporting should progress. In this context, the results presented in the current study should be seen only as showing trends. The data presented have been collected retrospectively and the only criterion for success is that at the time of data gathering the implant was considered integrated. Consequently, there are many variables not addressed in the data presented. The results do, however, provide important information on potential trends of individual implant success rates,

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potential for replication of results, and indications of directions for future research. In nonradiated patients (Tables 1 and 5), the success rates for orbits in the United States (96.3%) and Canada (96.6%) were very similar, whereas the Swedish result was 91.8%. This difference is likely attributable to the longer period of follow-up in the Swedish group. The total experience in the orbit is still relatively small in relation to the mastoid region experience, so that with time there may be a shift in the expected individual implant success rate in the orbit. In the mastoid region, the individual implant success rate is' remarkably uniform, with rates above 98% in all three countries. Even at this early juncture, the mastoid region appears to elicit predictable success rates with the use of osseointegrated implants. In the Canadian experience, very few implants have been placed into the nasal region, hence valid comment is not possible. Parel and Tjellstrm11 discussed the reported disparity in success of implants in the nasal region (Sweden 100%; United States 79.5%). They attributed the difference to the United States' sample being larger and perhaps the Swedish group having more experience with epithelial penetration factors. While the overall nonradiated patient group result indicates an expected success rate of 97.5%, it is evident that even in the nonradiated patient important variability exists in the expected regional success rates. The clinician should be well aware of these when considering treatment with extraoral implants. The success rates achieved in Sweden and Canada with placement of implants in the mastoid region for retention of bone-anchored hearing aids indicates that this procedure carries a very high rate of predictability (Sweden 99.7%; Canada 97.9%). For patients who require a bone-conduction hearing aid, the benefits of convenience alone in being able to wear a bone-anchored hearing aid add substantially to quality of life for these individuals. In the radiated patient group, the Canadian success rate (94.4%) was found to be far higher than either the Swedish or United States' results. As was suggested previously, this difference is thought to be a function of duration of follow-up and number of patients treated. There is little reason to believe that the success rate in Canada for radiated orbits will not sharply decline as the number of patients increases and the duration of follow-up is extended. The international experience for treatment in other regions (mastoid, nasal, other) is scant, and serious comment cannot be made at this time. The placement of fixtures in radiated tissue provides an important avenue for future research. There will undoubtedly be changes in the success rates for the different osseous regions with time. The influence of hyperbaric oxygen (HBO) therapy remains uncertain but promising at this time. For the past 3 years, preoperative and postoperative HBO has been administered to radiated patients in Gteborg. A modified Marx protocol12 has been used by administering 2.4 ATA (atmosphere absolute pressure) for 90 minutes once a day for 20 days preoperatively and 10 days postoperatively. The number of patients is considered too few and the follow-up period too short to report on 13

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formally, but the preliminary results are considered promising13 (Granstrm G, personal communication, 1992). The available data suggest expected baseline individual implant success rates for the mastoid region in nonradiated patients. Conversely, available data for radiated patients do not provide an expectation of baseline success rates. Clinicians contemplating extraoral implant placement in radiated patients might heed the words of caution issued by Parel and Tjellstrm.11 They considered the overall success rate in radiated patients to be disappointingly low. While these rates are lower than those desired, there could be a problem of continuity of concept from the oral experience. Only the mandible and maxilla are involved in the oral experience and these osseous foundations have been the subject of intense scrutiny, so that understanding of their biologic and mechanical behavior is enhanced. Intraoral implants are connected through the oral mucosa, which is bathed in saliva providing a tenacious protective environment for the soft tissue-abutment interface. In the case of extraoral implants, the biologic and mechanical milieu is very different. The osseous encasement of the extraoral implant varies greatly between regions, and the length of the implants is far shorter than that of the intraoral implants. The loads applied to extraoral implants are different and the connection through the skin to the external environment provides a totally different soft tissue environment for the abutment. It may not be wise to apply continuity of concept from the oral to the extraoral experience. If this is so, then it may be important not to expect osseous tissues of varying anatomic locations in the craniofacial skeleton to provide similar success rates. Likewise, osseointegration rates in the presence of adjunctive therapies might become acceptable at lower rates of integration. These lower rates of success should perhaps not currently be viewed as failure, but rather as attainable success rates for the present. Related to the issue of success rate interpretation of individual implants is the matter of what constitutes success. Extraoral implants can only be evaluated by assessing implant immobility and the periabutment skin reaction; they cannot be routinely radiographed at the present time. There are challenges ahead to determine objective means of extraoral implant assessment. Individual implant assessment provides little insight into patients' response to treatment. It may be disturbing to the clinician who routinely achieves 98% individual success rates with intraoral implants to have to accept 50% success rates in the orbit. However, this may not be important to a patient with an orbital defect who has had six implants placed, three of which have survived and adequately support an orbital prosthesis There is a need with craniofacial implants to develop success criteria that provide a wider view of what constitutes successful treatment outcome.

Conclusion
Craniofacial osseointegration provides a significant means of improving the quality of life for patients who wear facial prostheses and bone-anchored hearing aids. The

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international multicenter data presented indicate trends in expected success rates for orbital, nasal, mastoid, and other regions of the craniofacial complex in radiated and nonradiated patients. The mastoid and orbital regions provide a high degree of predictability with regard to extraoral implant usage. The use of extraoral implants in the midface and in all regions of radiated patients provides results of increased variability. Clinicians considering use of extraoral implants in the radiated patient should do so with the greatest care and within a clinical environment familiar with care of this category of patient. There is a need for research into factors influencing many of the biologic and mechanical aspects of extraoral osseointegration, particularly in radiated patients. The results presented should be interpreted as trends only because it is evident that as the number of implants assessed continues to grow and the duration of assessment increases, so the individual implant success rates will change. Attention must be given to prospective studies to evaluate treatment outcome with extraoral implants. Criteria for evaluation should be defined for extraoral osseointegration. These criteria should take into account the uniqueness of extraoral osseointegration and its distinctiveness from the intraoral experience.

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1. Lewis DH, Castleberry DJ. An assessment of recent advances in external maxillofacial materials. J Prosthet Dent 1980;43:426-432. 2. Chalian A, Bogan RL, Sandlewick JW. Retention of prostheses. In: Chalian VA, Drane JB, Standish SM (eds). Maxillofacial Prosthetics: Multidisciplinary Practise. Baltimore: Williams and Wilkins, 1972: ch 8. 3. Russouw C. The Bond Strength of Facial Prosthetic Adhesive Systems [thesis]. Johannesburg: University of Witwatersrand, 1987. 4. Page K. Assessment of the mechanical properties of some facial prosthetic adhesives: A preliminary report. In: Conroy BF, Proceedings of the International Congress on Maxillofacial Prosthetics and Technology. Southampton: Millbrook Press, 1983:410-419. 5. Bonner E. The Need for and Value of a Maxillofacial Prosthodontic Service in the Witwatersrand-Vaal Area [thesis]. Johannesburg, South Africa: University of Witwatersrand, 1984. 6. Parel SM, Brnemark P-I, Tjellstrm A, Gion G. Osseointegration in maxillofacial prosthetics. Part II: extraoral applications. J Prosthet Dent 1986;55:600-606. 7. Rahn AO, Boucher LJ. Maxillofacial ProstheticsPrinciples and Concepts, ed 1. Philadelphia: Saunders, 1970:113-187. 8. Roberts AC. Facial reconstruction by prosthetic means. Br J Oral Surg 1966;4:157-182. 9. Parel SM. Diminishing dependence on adhesives for retention of facial prostheses. J Prosthet Dent 1980;43:552-560. 10. Hulland CV, Hulland SM, Turner TD. Adhesion to skin principles and applications. In: Conroy BF, Proceedings of the International Congress on Maxillofacial Prosthetics and Technology. Southampton: Millbrook Press, 1983:402-409. 11. Parel SM, Tjellstrm A. The United States and Swedish experience with osseointegration and facial prostheses. Int J Oral Maxillofac Implants 1991;6:75-79. 12. Marx RE, Johnson RP, Kline SN. Prevention of osteoradionecrosis: A randomized prospective clinical trial of hyperbaric oxygen versus penicillin. J Am Dent Assoc 1985;111:49-54. 13. Granstrm G, Jacobsson M, Tjellstrm A. Titanium implants in irradiated tissue: Benefits from hyperbaric oxygen. Int J Oral Maxillofac Implants 1992;7:15-25.

JOMI on CD-ROM, 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E

Copyrights 1997 Quinte

JOMI on CD-ROM, 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E

Copyrights 1997 Quinte

JOMI on CD-ROM, 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E

Copyrights 1997 Quinte

JOMI on CD-ROM, 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E

Copyrights 1997 Quinte

JOMI on CD-ROM, 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E

Copyrights 1997 Quinte

Fig. 1 This 32-year-old patient has right-sided hemifacial microsomia and an associated microtia. The patient had undergone numerous surgical revisions over the years and was dissatisfied with the result. Note the apparent downward and forward movement of the reconstructed ear.

Fig. 2 Bar connects three implants, which have been placed into the mastoid region to support an auricular prosthesis .

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Fig. 3 This view of the fitting surface of the silicone prosthesis shows that the resin substructure houses the retentive clips.

Fig. 4 Extraoral implant-retained auricular prosthesis in position on the patient.

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Fig. 5 Abutment for a bone-anchored hearing aid connected through the skin behind the ear. Note the skin graft placed around the abutment to ensure a nonmobile and hairless zone around the abutment.

Fig. 6 Abutment for a bone-anchored hearing aid penetrates the skin behind the ear. Note the plastic insert for connecting the hearing aid.

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Fig. 7 Bone-anchored hearing aid connected to the abutment.