Research Article| Volume 60, ISSUE 6, P615-621, June 2007

Download started.


Preclinical animal study and clinical trail of modified extraoral craniofacial implants

Published:February 02, 2007DOI:


      We report on our experience using a new endosseous implant designed to provide sufficient retention to various types of facial prostheses.
      In a preclinical animal experiment implants (N=12, 4×3.5 mm) were placed in the frontal calvarial region of nine adult pigs. The animals were sacrificed at 2, 4 and 8 weeks to evaluate the implant incorporation microradiographically.
      The clinical outcome and patient satisfaction of implant-retained prostheses were evaluated in a group of 10 patients with facial defects by using clinical assessment and standardized questionnaires for patients and relatives. In the prospective clinical study 33 identical modified implants for extraoral anchorage were placed for the fixation of various prostheses in the midfacial (eye, nose) and ear regions in the course of a clinical trial and observed over a follow-up period of 34 months.
      The bone-implant contact in the animal experiment reached 31% (±2) at 2 weeks, 39% (±1) after 4 weeks and 51% (±5) at 8 weeks. In the clinical trial, no implants were lost and all implants remained osseointegrated as confirmed clinically and radiographically, providing a stable prosthetic restoration. The analysis of the questionnaire indicates an improvement of the quality of life of patients with respect to aesthetic and psychological well-being.
      The results demonstrate that extraoral implants not only achieve sufficient osseointegration but also show good clinical handling and easy fixation possibilities for prosthetic anchorage.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Journal of Plastic, Reconstructive & Aesthetic Surgery
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Abu-Serriah M.M.
        • McGowan D.A.
        • Moos K.F.
        • et al.
        Outcome of extra-oral craniofacial endosseous implants.
        Br J Oral Maxillofac Surg. 2001; 39: 269-275
        • 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
        • Belus J.F.
        • Kaplanski P.
        • Blanc J.L.
        • et al.
        Orbito-maxillo-facial rehabilitation with osteointegrated prostheses.
        Ann Otolaryngol Chir Cervicofac. 1996; 113: 397-407
        • Branemark P.I.
        • Albrektsson T.
        Titanium implants permanently penetrating human skin.
        Scand J Plast Reconstr Surg. 1982; 16: 17-21
        • Del V.V.
        • Faulkner G.
        • Wolfaardt J.
        • et al.
        Mechanical evaluation of craniofacial osseointegration retention systems.
        Int J Oral Maxillofac Implants. 1995; 10: 491-498
        • Donath K.
        Die Trenn-Dünnschlifftechnik zur Herstellung histologischer Präparate von nicht schneidbaren Geweben und Materialien.
        Der Präparator. 1988; 34: 197-206
        • Donath K.
        • Breuner G.
        A method for the study of undecalcified bones and teeth with attached soft tissues. The Sage-Schliff (sawing and grinding) technique.
        J Oral Pathol. 1982; 11: 318-326
        • Drommer R.
        Mini-Pig als Versuchstier in der experimentellen Chirurgie des Mittelgesichtes.
        Dtsch Z Mund Kiefer Gesichts Chir. 1981; 5: 358-360
        • Eitel F.
        • Seiler H.
        • Schweiberer L.
        Vergleichende morphologische Untersuchungen zur Übertragbarkeit tierexperimenteller Ergebnisse auf den Regenerationsprozess des menschlichen Röhrenknochens.II.Untersuchungsergebnisse.
        Unfallheilkunde. 1981; 84: 250-264
        • Franic D.M.
        • Pathak D.S.
        Assessment of respondent acceptability of preference measures: discriminatory power of graphic positioning scale versus traditional scaling measures.
        Value Health. 2003; 6: 483-493
        • Franzen L.
        • Rosenquist J.B.
        • Rosenquist K.I.
        • et al.
        Oral implant rehabilitation of patients with oral malignancies treated with radiotherapy and surgery without adjunctive hyperbaric oxygen.
        Int J Oral Maxillofac Implants. 1995; 10: 183-187
        • Freitag V.
        • Stetter W.
        • Holtje W.J.
        Contact microradiography of bone sections with various radiation properties.
        Dtsch Zahnarztl Z. 1980; 35: 74-77
        • Granstrom G.
        • Bergstrom K.
        • Odersjo M.
        • et al.
        Osseointegrated implants in children: experience from our first 100 patients.
        Otolaryngol Head Neck Surg. 2001; 125: 85-92
        • Granstrom G.
        • Tjellstrom A.
        • Branemark P.I.
        Osseointegrated implants in irradiated bone: a case-controlled study using adjunctive hyperbaric oxygen therapy.
        J Oral Maxillofac Surg. 1999; 57: 493-499
        • Granstrom G.
        • Tjellstrom A.
        • Branemark P.I.
        • et al.
        Bone-anchored reconstruction of the irradiated head and neck cancer patient.
        Otolaryngol Head Neck Surg. 1993; 108: 334-343
        • Holgers K.M.
        • Tjellstrom A.
        • Bjursten L.M.
        • et al.
        Soft tissue reactions around percutaneous implants: a clinical study on skin-penetrating titanium implants used for bone-anchored auricular prostheses.
        Int J Oral Maxillofac Implants. 1987; 2: 35-39
        • Jacobsson M.
        • Tjellstrom A.
        • Fine L.
        • et al.
        An evaluation of auricular prosthesis using osseointegrated implants.
        Clin Otolaryngol. 1992; 17: 482-486
        • Jacobsson M.
        • Tjellstrom A.
        • Thomsen P.
        • et al.
        Integration of titanium implants in irradiated bone. Histologic and clinical study.
        Ann Otol Rhinol Laryngol. 1988; 97: 337-340
        • Klomp G.F.
        • Womack III, M.
        • Dobelle W.H.
        Percutaneous connections in man.
        Trans Am Soc Artif Intern Organs. 1979; 25: 1-7
        • Knobber D.
        • Brusis T.
        • Siranli F.
        Epithetical management of tumor-induced facial defects.
        Laryngol Rhinol Otol (Stuttg). 1986; 65: 32-36
        • Menneking H.
        • Klein M.
        • Locke H.G.
        • et al.
        Postoperative management of bone-anchored facial prostheses.
        HNO. 1998; 46: 579-582
        • Moran W.J.
        • Toljanic J.A.
        • Panje W.R.
        Implant-retained prosthetic rehabilitation of orbital defects.
        Arch Otolaryngol Head Neck Surg. 1996; 122: 46-50
        • Muller F.
        • Schadler M.
        • Wahlmann U.
        • et al.
        The use of implant-supported prostheses in the functional and psychosocial rehabilitation of tumor patients.
        Int J Prosthodont. 2004; 17: 512-517
        • Nentwig G.H.
        NM-system. Concept of an implant solution.
        Niedersachs Zahnarztebl. 1991; 26: 658-662
        • Parel S.M.
        • Tjellstrom A.
        The United States and Swedish experience with osseointegration and facial prostheses.
        Int J Oral Maxillofac Implants. 1991; 6: 75-79
        • Rubenstein J.E.
        Attachments used for implant-supported facial prostheses: a survey of United States, Canadian, and Swedish centers.
        J Prosthet Dent. 1995; 73: 262-266
        • Schlegel K.A.
        • Kloss F.R.
        • Schultze-Mosgau S.
        • et al.
        Osseous defect regeneration using autogenous bone alone or combined with Biogran or Algipore with and without added thrombocytes. A microradiologic evaluation.
        Mund Kiefer Gesichtschir. 2003; 7: 112-118
        • Schlegel K.A.
        • Schultze-Mosgau S.
        • Wiltfang J.
        Implantology in oromaxillofacial surgery.
        HNO. 2002; 50: 699-718
        • Schliephake H.
        • Neukam F.W.
        • Schmelzeisen R.
        • et al.
        Long-term results of endosteal implants used for restoration of oral function after oncologic surgery.
        Int J Oral Maxillofac Surg. 1999; 28: 260-265
        • Schortinghuis J.
        • Ruben J.L.
        • Meijer H.J.
        • et al.
        Microradiography to evaluate bone growth into a rat mandibular defect.
        Arch Oral Biol. 2003; 48: 155-160
        • Thomas K.F.
        Prosthetic rehabilitation.
        Dent Tech. 1987; 40: 12-16
        • Tjellstrom A.
        • Portmann D.
        Osseointegrated implants in facial prosthesis and hearing aids.
        Rev Laryngol Otol Rhinol (Bord). 1992; 113: 439-445
        • van Oort R.P.
        • Reintsema H.
        • van Dijk G.
        • et al.
        Indications for extra-oral implantology.
        J Invest Surg. 1994; 7: 275-281
        • van Oort R.P.
        • Roodenburg J.L.
        • van Dijk G.
        • et al.
        Prosthetic reconstruction after oncological surgery in the head and neck region.
        Ned Tijdschr Tandheelkd. 1996; 103: 365-368
        • Wang R.R.
        • Andres C.J.
        Hemifacial microsomia and treatment options for auricular replacement: a review of the literature.
        J Prosthet Dent. 1999; 82: 197-204
        • Wright R.F.
        • Wazen J.J.
        • Asher E.S.
        • et al.
        Multidisciplinary treatment for an implant retained auricular prosthesis rehabilitation.
        N Y State Dent J. 1999; 65: 26-31