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Alveolar ridge augmentation with hydroxylapatite using fibrin sealant for fixation
Alveolar ridge augmentation with hydroxylapatite using fibrin sealant for fixation
Gfinter Hotz Department of Maxillofacial Surgery, University of Heidelberg, Germany
Part I1: Clinical application G. Hotz: Alveolar ridge augmentation with hydroxylapatite using fibrin sealant for fixation. Part II: Clinical application. J. Oral Maxillofac. Surg. 1991; 20: 208-213. Abstract. The use of fibrin as a resorbable biological adhesive permits moulding of H A granules into individually shaped implants. The binder prevents dislocation of granules during delivery, and the moulded implants securely retain their shape until fibrous tissue ingrowth is complete. Three years of clinical experience have shown that, mouldable fibrin-bound H A has so far proved suitable as a bone substitute in preprosthetic as well as in plastic and reconstructive surgery.
Granular hydroxylapatite (HA) was first introduced as an alloplastic bone substitute in alveolar ridge augmentation by K e n t et al. 17 in 1982 and is now used worldwide. The initial instability encountered when the ceramic is wetted with saline or the patient's own blood and deposited subperiosteally poses considerable clinical problems in some patients. Primarily, as a result of tears in the periosteum due to extensive stripping and damage during filling, partial dislocation of granules into the vestibular soft tissue and the floor of the m o u t h may occur. In addition, the particles may migrate before they have been stabilized by connective tissue ingrowth, which results in loss of ridge contour. To eliminate these problems, several solutions have been suggested, including the use o f splints ~7, open splints for mandible 26, two-piece splints 2°, and palatal open splints 3, special s u t u r e techniques 27, Vicryl ~ tubes 1°, fixation media, e.g. collagen =, fibrin ~and plaster of Paris 8,29, 2-step procedures: subperiosteal tissue expanders 2,3,12,2~ as well as temporary subperiosteal implants ~9'24. A method is introduced in which in situ fixation of H A particles using fibrin sealant is used. It provides temporary cohesiveness to particles at the time of insertion and maintains the
required shape and height during fibrous tissue ingrowth.
Material and methods
In the period between June 1987 and October 1990, 107 alveolar ridges were reconstructed with mouldable implants in 84 patients. Thirty-nine patients underwent maxillary augmentation and 68 mandibular augmentation. In 23 patients, both maxillary and mandibular augmentation was performed. In 16 cases, postforaminal mandibular augmentation was combined with insertion of cylindrical implants in the area between the mental foramina and vestibuloplasty as described by EDLAN7. Eighty percent of the patients (67 of 84) were women. At the beginning of treatment, 9 patients were younger than 50 years, 50 patients were between 50 and 65 years, and the remaining 25 patients were over 65 years of age (average 62 years). Surgery was generally performed under local anaesthesia, and perioperative prophylactic antimicrobial therapy was given for 48 h at the most. In patients with increased risk, such as insulindependent diabetics or dialysis-dependent kidney patients, administration of antibiotics was extended to 5 8 days. In the mandible, bilateral vertical incisions in the canine region in front of the mental nerve were extended to the floor of the mouth. The vertical incisions were then extended through the submucosal tissues and periosteum, and elevation of the periosteum over the alveolar ridge was performed lingual
Key words: alveolar ridge augmentation; contour augmentation; hydroxylapatite; fibrin sealant; fibrin glue. Accepted for publication 14 February 1991
to the foramen. The HA-fibrin paste was then placed lingual to the nerve, even in severe class VI cases. Care was taken to prepare the tunnel as lingual as possible to the mylohyoidal ridge, avoiding damage to the periosteum. A double-ended z-shaped periosteal elevator was used to prepare the interforaminal tunnel (Fig. 1). In the maxilla, augmentation was combined with a submucosal vestibuloplasty23. For this purpose, the vertical midline incision was extended from the alveolar crest to the palatal papilla. Flabby ridges were thinned by means of a periosteal dissector with a sickle-shaped working end (Fig. 1). An initially mouldable implant mixture of solid dense HA granules (Frialit ®, Friedrichsfeld GmbH, Mannheim, Germany) and fibrin sealant (Tissucol®, Tisseel ®*, Immuno GmbH, Heidelberg, Germany) was used. Delivery of this HA-fibrin paste from a syringe was ~bssible for at least 10 rain, and the implant remained mouldable in situ for at least another 10 min before turning into a rubbery consistence (Fig. 2). External devices, e.g. splints or modified dentures, for fixation of HA granules were not used in the mandible. In the maxilla, augmentation was always combined with a submucosal vestibuloplasty 23, and therefore a palatal open splint was inserted postoperatively, se
* Tissucol® and Tisseel~ are registered trademarks of IMMUNO's 2-component fibrin sealant in different countries.
HA-fibrin implants for ridge augmentation H
209
Fig. 1. Instruments for alveolar ridge augmentation: fine delta-shaped raspatorium (a); double-ended, slightly curved elevator (b); doubleended, z-shaped, slightly curved elevator (c); periosteal dissector with sickle-shaped working end (d); graft packer (e); (Oswald Leibinger GmbH, M/ihlheim-Stetten, Germany). Fig. 2. Delivery of hydroxylapatite-fibrin paste from a syringe. The paste remains injectable for at least 10 rain and mouldable for another 10 min.
cured with a transpalatal screw and left in place for 1 week. The combination of vestibuloplasty and augmentation in the anterior region requires a palatal placement of the implant material. The palatal open splint enables the tongue to mould the implant passively to the desired place over the alveolar
ridge. The shape and position of the implants were routinely monitored by panoramic radiography, lateral cephalography and, in some patients, by high-resolution coronary computed tomography (HR-CT). The chosen reference plane was 1 cm posterior to the mental foramen (Fig. 3).
Results
Total mandibular augmentation, postforaminal mandibular augmentation and maxillary augmentation required 14 g, 7.2 g and 8.2 g, respectively. With
Fig. 3. Coronary HR-CT (reference plane 1 cm posterior to the mental foramen) showing measurement of the absorption values 1 week after maxillary and mandibular augmentation (a). The detailed CT images permit judgement of the ceramic implant's shape and position in both the maxilla and the mandible. Maxillary atrophy with a knife-edge appearance (Kent class II), reconstructed with HA-fibrin sealant (b). Mandibular atrophy to the level of the basilar bone (Kent class III) (c). The fibrin-bound ceramic was placed all the way to the mylohyoidal line on the lingual side of the deficient ridge. The canal of the mandibular nerv~ is also visible (*).
210
Hotz
Fig. 4. Female patient aged 64 years with atrophic mandible (before) and 3 years after augmentation.
prophylactic penicillin, given perioperatively for no longer than 48 h, wound healing proceeded without complications. Minor incision dehiscences healed spontaneously without any significant loss of granules. Seromas of the floor of the mouth were observed occasionally but did not influence wound healing. On 5 occasions, antimicrobial therapy was instituted because of infection some 5 to 8 days postoperatively, after which healing was uneventful. No permanent complete lip anaesthesias were observed. Small areas of hypaesthesia were noticed in approx, one half of the patients. Transient mental nerve hypaesthesias/dysaesthesias occurred, especially in cases of severely atrophic mandible. In nearly all cases (31/36) of mental nerve dysaesthesia normal sensation returned to the lower lip by the 6th postoperative month. Nerve function was evaluated by a brush directional test. Allergic reactions were not observed. After 4 to 6 weeks, the implants were firm enough to permit prosthetic rehabilitation to be commenced. The cases in which computed tomo-
graphy (CT) was employed showed an increase by 400 Hounsfield units (HU) in the CT absorption up to the 5th postoperative week. No further changes in the CT absorption parameter were observed up to 24 months, indicating that fibrous tissue ingrowth and implant condensation were complete after 5 weeks ~4. The implants were found to retain both shape and position (Figs. 4, 5). Skin or mucosal graft vestibuloplasties to deepen the sulcus were performed on 27 patients with severely atrophic mandibles (KENT 17 classes III and IV or CAWOOD & HOWELL5 classes V and VI) after 12 weeks (Fig. 6). In 16 cases where there was a vertical height of at least 12 mm in the frontal region, postforaminal augmentation in the lateral region was performed in combination with an Edlan 7 vestibuloplasty and concomitant insertion of cylindric implants (Fig. 7).
Discussion
Various techniques to stabilize H A granules have been reported. Although
surgical splints have been recommended for confinement of HA granules they do not necessarily prevent migration of HA particles TM. In our experience, the use of splints often caused pressure ulcers and secondary dislocation of granules, particularly around circum-mandibular wires. The use of a Vicryl tube increases the incidence of suture dehiscences and mucosal ulcers 14'25. The binder/filler, plaster of Paris, is insufficiently biocompatible, and its resorption results in significant condensation of H A 4'8. Pre-implantation of a subperiosteal tissue expander or acrylic resin body prevents later migration of the granules. The tissue expansion causes a widening of the connective tissue and a secondary hyperplasia of the mucosa 12. These procedures, however, require a second surgery after a few weeks. It is sometimes necessary to remove redundant granulation tissue, thus enhancing the risk of nerve damage. The fibrin sealant system has been used successfully in a variety of clinical applications including haemostasis, sealing leakages, glueing tissue, or supporting sutures. The safety
Fig. 5. Female patient aged 72 years with severely atrophic maxilla preoperative (a) and 3 years after augmentation (b).
HA-fibrin implants for ridge augmentation H
of the allogenic plasma protein with respect to transmission of viral infections (hepatitis A, non-A/non-B hepatitis, HIV) has been investigated and confirmed in a number of clinical studies 6,9,2s'3°.The fibrin network is infiltrated and resorbed by macrophages and polynuclear neutrophil granulocytes within 2 weeks H. Simultaneously, vascularized, fibroblast-rich granulation tissue grows into the spaces between the granules, replacing the fibrin links between the HA-particles. In an experimental study, collagen-
bound HA-granules induced foreignbody reactions 13 and in a clinical study 10% of the patients showed immunological reaction 22. In the present study, allogenic fibrin adhesive did not induce any inflammatory or allergic reaction. In cases of severe mandibular ridge deficiency, loss of sulcus depth is inevitable after H A augmentation. Even the use of fixed splints for 3 weeks does not prevent the need for vestibuloplasty~s. Equally, in most cases the fibrin sealant method is unable to maintain the exist-
211
ing sulcus depth. Dislocation and migration of H A granules, however, even in cases of severe atrophy, were not observed. The use of HA-fibrin adhesive in a 1:l ratio has been reported by BOCHLOGYROS et al. ~ for making preformed blocks out of H A granules. By reducing the thrombin concentration from 4 IU/ ml to 1 IU/ml and increasing the HA:fibrin ratio to 6:1, a mixture of H A granules and fibrin sealant has been developed, which can be moulded in situ according to the individual needs of pa-
212
Ho tz
tients. The fibrin binds the granules and seals periosteum ruptures. In the animal model, the distance between the fibrin-bound, polygonal HA particles remained almost constant during fibrous tissue ingrowth aS. Two factors seem to be important for the implant to retain its volume and shape and its position in extraosseous tissue: the polygonal shape of the HA granules and the temporary space maintaining of the fibrin links. WITTKAMPF32mixed autologous plasma cryoprecipitate solution containing fibrinogen and factor XIII prepared from 450 cc of the patient's blood, obtained 2 weeks previously, with HA granules in the applicator syringe. The material in the syringe was then mixed with a homologous 500 IU thrombin solution. The method has been used only for Kent classes I and II or Cawood & Howell class IV atrophic ridges, or for local defects. A splint is fixed in place for 2 weeks. With this method there is not complete control of the granules by the fibrin glue alone. This
may be due to the inconsistent quality of autologous plasma protein preparation. During the 3 years experience with fibrin sealant, this technique has proved to be most suitable for construction of shape-retaining HA-implants. No migration and displacement of particles was observed. Even under loading with a denture, which was done after 6 weeks, there was neither loss of ridge c o n t o u r nor migration of granules. Computed tomography showed that integration, i.e. fibrovascular ingrowth, of the HA granules was complete after 5 weeks and that mastication did not lead to dislocation or further condensation14. There are various further applications for mouldable fibrin-bound implants in plastic and reconstructive surgery to correct bone contour defects. Augmentation can in most cases be achieved via incisions that leave no visible scars 16. References 1. BOCHLOGYROSPN, HENSHER R, BECKER
R, ZIMMERMANNE. A modified hydroxylapatite implant material. J Maxillofac Surg 1985: 13: 213-17. 2. BOCK NJJ, Rose R. Der subperiostale Gewebeexpander als Hilfsmittel bei der Alveolarkammplastik. Dtsch Z Mund Kiefer Gesichts Chit 1987: 11: 443-7. 3. BONOMOD. Subperiostal tissue expander
for ridge augmentation. CDS Rev 1986: 4: 34-9. 4. BUSCHHE Kalziumsulfat ein Knochenersatzmittel? Dtsch Zahnfirztl Z 1985: 40: 678-80. 5. CAWOOD JT, I~OWELL RA. A classification of the edentulous jaws. Int J Oral Maxillofac Surg 1988: 17: 232-6. 6. EDER G, NEUMANNM, CERWENKAR, BAUMGARTENK. Preliminary results of a randomized controlled study on the risk of hepatitis transmission of a two-component fibrin sealant (Tissucol/Tisseel).In: SCHLAGG, REDL H eds. Fibrin sealant in operative medicine. Berlin: Springer, 1986: 51-9. 7. EDLANA. Preprosthetic surgery - a new technique in the edentulous lower jaw. Oral Surg Trans 4th Int Congress Oral Surg, Copenhagen 1973: 191. 8. FRAME JW, ROUT PGJ, BROWNE RM. Ridge augmentation using solid and po-
HA-fibrin implants for ridge augmentation H rous hydroxylapatite particles with and without autogenous bone plaster. J Oral Maxillofac Surg 1987: 45: 771-7. 9. GASTPARU. Fibrinklebung bei Patienten mit h/imorrhagischen Diathesen. In: SCI-mELE J, ed. Fibrinktebung. Berlin: Springer, 1984: 283-6. 10. H~IRLEF. M6glichkeiten und Grenzen der prfiprothetischen Chirurgie am Unterkiefer. 2. Jtg. Arbeitskreis Implantotogie, DGZMK Berlin 1985. 11. HEINEWK, ED1NGERD, BRAUNA. Wundheilung nach Fibrinkleber in Orthopfidie und Traumatologie. 4. Heidelberger Orthopfidie-Symposium. Stuttgart: Thieme, 1982: 27-34. 12. HOTZ G, FRITZ R Die Granulatfixation beim Alveolarkammaufbau mit Hydroxylapatit. Erste Erfahrungen mit einem subperiostalen Gewebeexpander. Dtsch Zahn/irztl Z 1988: 43: 85-8. 13. HOTZ G, MALL G, BORN IA, GILDE H. Kollagen und Fibrin als biologische Bindemittel ffir Hydroxylapatit-Granulat. Dtsch Z Mund Kiefer Gesichts Chir 1989: 13: 296-9. 14. HOTZ G, KRISTEN K, FRITZ P. Alveolarkammaufbau mit formbaren Implantaten aus Hydroxylapatit-Granulat und Fibrinkleber. Dtsch Z Mund Kiefer Gesichts Chir 1989: 13: 363-6. 15. HOTZ G. Alveolar ridge augmentation with hydroxylapatite using fibrin sealant for fixation. Part I: an experimental study. Int J Oral Maxillofac Surg 1991: 20:
16. HOTZ G. Konturkorrektur mit formbaren Implantaten aus Hydroxylapatitkera-
mik Fibrinklebung. In: SCHWENZERN, ed. Hefte zur Unfallchirurgie, Plastischen und Wiederherstellungschirurgie. Rotenburg, Sasse, 1991 (in press). 17. KENT JN, QUINN JH, ZIDE MF, FINGER JM, JARCHO M, ROTHSTEIN as. Correction of alveolar ridge deficiencies with nonresorbable hydroxylapatite. J Am Dent Assoc 1982: 105: 993-1001. 18. KENT JN, FINGER IM, QUINN JH, GUERm~ LR. Hydroxylapatite alveolar ridge reconstruction. J Oral Maxillofac Surg 1986: 44: 37M9. 19. KROGERE. Alveolarkammaufbau im Unterkiefer mit Hydroxylapatitkeramik. Dtsch Z Munk Kiefer Gesichts Chir 1985: 9: 194-5. 20. LAMBERTPM. A two-piece surgical splint to facilitate hydroxylapatite augmentation of the mandibular alveolar rigde. J Oral Maxillofac Surg 1986: 44: 329-31. 21. LEW D, CLARK R, SHAHBAZIANT. Use of a soft tissue expander in alveolar ridge augmentation. J Oral Maxillofac Surg 1986: 44: 516-19. 22. MEHLISCrt DR, TAWOR TD, LEIBOLD DG, et al, Evaluation of coltagen/hydroxylapatite for augmenting deficient alveolar ridges. A preliminary report. J Oral Maxillofac Surg 1987: 45:408 13. 23. OBWEGESER H. Die submuk6se Vestibulumplastik. Dtsch Zahngrztl Z 1959: 14: 629-39. 24. OSBORN JF, KAPOVITZ M, KARL P. Die zweizeitige Augmentation des atrophischen Kiefers mit Hydroxylapatitkeramik-Granulat. Coll Med Dent 1986: 30: 149-60.
213
25. PAVEH-D, GERLACHKL. Ergebnisse der Kieferkammaugmentation mit Hydroxylapatit. Dtsch Zahnfirztl Z 1988: 43: 78-80. 26. PHAM H. Use of an open splint in ridge augmentation with hydroxylapatite. J Oral Maxillofac Surg 1986: 44:80 1. 27. PROPPER RH. A technique for controlled placement of hydroxylapatite over atrophic mandibular ridges. J Oral Maxillofac Surg 1985: 43: 469-70. 28. Rousou J, GONZALEZ-LAVIN L, CosGROW D, et al. Randomized clinical trial of fibrin sealant in patients undergoing restenotomy or reoperation after cardiac operations. J Thorac Cardiovasc Surg 1989: 97: 194-203. 29. STOEL1NGA PJW. Die Augmentation im Motarenbereich des Unterkiefers mit Hydroxylapatit und gleichzeitiger Sandwichosteotomie im Symphysenbereich. 2. K61ner Symposium Hydroxylapatitkeramik, K6tn 1985. 30. SUGG U. Risiko der Hepatitisfibertragung durch humanen Fibrinkleber. Dtsch Med Wochenschr 1985: 110:1161 2. 31. TERRY BC. Personal communication 1988. 32. WITTKAMPFARM. Fibrin glue as cement for HA-granules. J Cranio-Maxillofac Surg 1989: 17: 179-81. Address:
Priv.-Doz. Dr. Dr. Giinter Hotz Department of Maxillofacial Surgery University of Heidelberg Im Neuenheimer Feld 400 1)-6900 Heidelberg Germany
Gfinter Hotz Department of Maxillofacial Surgery, University of Heidelberg, Germany
Part I1: Clinical application G. Hotz: Alveolar ridge augmentation with hydroxylapatite using fibrin sealant for fixation. Part II: Clinical application. J. Oral Maxillofac. Surg. 1991; 20: 208-213. Abstract. The use of fibrin as a resorbable biological adhesive permits moulding of H A granules into individually shaped implants. The binder prevents dislocation of granules during delivery, and the moulded implants securely retain their shape until fibrous tissue ingrowth is complete. Three years of clinical experience have shown that, mouldable fibrin-bound H A has so far proved suitable as a bone substitute in preprosthetic as well as in plastic and reconstructive surgery.
Granular hydroxylapatite (HA) was first introduced as an alloplastic bone substitute in alveolar ridge augmentation by K e n t et al. 17 in 1982 and is now used worldwide. The initial instability encountered when the ceramic is wetted with saline or the patient's own blood and deposited subperiosteally poses considerable clinical problems in some patients. Primarily, as a result of tears in the periosteum due to extensive stripping and damage during filling, partial dislocation of granules into the vestibular soft tissue and the floor of the m o u t h may occur. In addition, the particles may migrate before they have been stabilized by connective tissue ingrowth, which results in loss of ridge contour. To eliminate these problems, several solutions have been suggested, including the use o f splints ~7, open splints for mandible 26, two-piece splints 2°, and palatal open splints 3, special s u t u r e techniques 27, Vicryl ~ tubes 1°, fixation media, e.g. collagen =, fibrin ~and plaster of Paris 8,29, 2-step procedures: subperiosteal tissue expanders 2,3,12,2~ as well as temporary subperiosteal implants ~9'24. A method is introduced in which in situ fixation of H A particles using fibrin sealant is used. It provides temporary cohesiveness to particles at the time of insertion and maintains the
required shape and height during fibrous tissue ingrowth.
Material and methods
In the period between June 1987 and October 1990, 107 alveolar ridges were reconstructed with mouldable implants in 84 patients. Thirty-nine patients underwent maxillary augmentation and 68 mandibular augmentation. In 23 patients, both maxillary and mandibular augmentation was performed. In 16 cases, postforaminal mandibular augmentation was combined with insertion of cylindrical implants in the area between the mental foramina and vestibuloplasty as described by EDLAN7. Eighty percent of the patients (67 of 84) were women. At the beginning of treatment, 9 patients were younger than 50 years, 50 patients were between 50 and 65 years, and the remaining 25 patients were over 65 years of age (average 62 years). Surgery was generally performed under local anaesthesia, and perioperative prophylactic antimicrobial therapy was given for 48 h at the most. In patients with increased risk, such as insulindependent diabetics or dialysis-dependent kidney patients, administration of antibiotics was extended to 5 8 days. In the mandible, bilateral vertical incisions in the canine region in front of the mental nerve were extended to the floor of the mouth. The vertical incisions were then extended through the submucosal tissues and periosteum, and elevation of the periosteum over the alveolar ridge was performed lingual
Key words: alveolar ridge augmentation; contour augmentation; hydroxylapatite; fibrin sealant; fibrin glue. Accepted for publication 14 February 1991
to the foramen. The HA-fibrin paste was then placed lingual to the nerve, even in severe class VI cases. Care was taken to prepare the tunnel as lingual as possible to the mylohyoidal ridge, avoiding damage to the periosteum. A double-ended z-shaped periosteal elevator was used to prepare the interforaminal tunnel (Fig. 1). In the maxilla, augmentation was combined with a submucosal vestibuloplasty23. For this purpose, the vertical midline incision was extended from the alveolar crest to the palatal papilla. Flabby ridges were thinned by means of a periosteal dissector with a sickle-shaped working end (Fig. 1). An initially mouldable implant mixture of solid dense HA granules (Frialit ®, Friedrichsfeld GmbH, Mannheim, Germany) and fibrin sealant (Tissucol®, Tisseel ®*, Immuno GmbH, Heidelberg, Germany) was used. Delivery of this HA-fibrin paste from a syringe was ~bssible for at least 10 rain, and the implant remained mouldable in situ for at least another 10 min before turning into a rubbery consistence (Fig. 2). External devices, e.g. splints or modified dentures, for fixation of HA granules were not used in the mandible. In the maxilla, augmentation was always combined with a submucosal vestibuloplasty 23, and therefore a palatal open splint was inserted postoperatively, se
* Tissucol® and Tisseel~ are registered trademarks of IMMUNO's 2-component fibrin sealant in different countries.
HA-fibrin implants for ridge augmentation H
209
Fig. 1. Instruments for alveolar ridge augmentation: fine delta-shaped raspatorium (a); double-ended, slightly curved elevator (b); doubleended, z-shaped, slightly curved elevator (c); periosteal dissector with sickle-shaped working end (d); graft packer (e); (Oswald Leibinger GmbH, M/ihlheim-Stetten, Germany). Fig. 2. Delivery of hydroxylapatite-fibrin paste from a syringe. The paste remains injectable for at least 10 rain and mouldable for another 10 min.
cured with a transpalatal screw and left in place for 1 week. The combination of vestibuloplasty and augmentation in the anterior region requires a palatal placement of the implant material. The palatal open splint enables the tongue to mould the implant passively to the desired place over the alveolar
ridge. The shape and position of the implants were routinely monitored by panoramic radiography, lateral cephalography and, in some patients, by high-resolution coronary computed tomography (HR-CT). The chosen reference plane was 1 cm posterior to the mental foramen (Fig. 3).
Results
Total mandibular augmentation, postforaminal mandibular augmentation and maxillary augmentation required 14 g, 7.2 g and 8.2 g, respectively. With
Fig. 3. Coronary HR-CT (reference plane 1 cm posterior to the mental foramen) showing measurement of the absorption values 1 week after maxillary and mandibular augmentation (a). The detailed CT images permit judgement of the ceramic implant's shape and position in both the maxilla and the mandible. Maxillary atrophy with a knife-edge appearance (Kent class II), reconstructed with HA-fibrin sealant (b). Mandibular atrophy to the level of the basilar bone (Kent class III) (c). The fibrin-bound ceramic was placed all the way to the mylohyoidal line on the lingual side of the deficient ridge. The canal of the mandibular nerv~ is also visible (*).
210
Hotz
Fig. 4. Female patient aged 64 years with atrophic mandible (before) and 3 years after augmentation.
prophylactic penicillin, given perioperatively for no longer than 48 h, wound healing proceeded without complications. Minor incision dehiscences healed spontaneously without any significant loss of granules. Seromas of the floor of the mouth were observed occasionally but did not influence wound healing. On 5 occasions, antimicrobial therapy was instituted because of infection some 5 to 8 days postoperatively, after which healing was uneventful. No permanent complete lip anaesthesias were observed. Small areas of hypaesthesia were noticed in approx, one half of the patients. Transient mental nerve hypaesthesias/dysaesthesias occurred, especially in cases of severely atrophic mandible. In nearly all cases (31/36) of mental nerve dysaesthesia normal sensation returned to the lower lip by the 6th postoperative month. Nerve function was evaluated by a brush directional test. Allergic reactions were not observed. After 4 to 6 weeks, the implants were firm enough to permit prosthetic rehabilitation to be commenced. The cases in which computed tomo-
graphy (CT) was employed showed an increase by 400 Hounsfield units (HU) in the CT absorption up to the 5th postoperative week. No further changes in the CT absorption parameter were observed up to 24 months, indicating that fibrous tissue ingrowth and implant condensation were complete after 5 weeks ~4. The implants were found to retain both shape and position (Figs. 4, 5). Skin or mucosal graft vestibuloplasties to deepen the sulcus were performed on 27 patients with severely atrophic mandibles (KENT 17 classes III and IV or CAWOOD & HOWELL5 classes V and VI) after 12 weeks (Fig. 6). In 16 cases where there was a vertical height of at least 12 mm in the frontal region, postforaminal augmentation in the lateral region was performed in combination with an Edlan 7 vestibuloplasty and concomitant insertion of cylindric implants (Fig. 7).
Discussion
Various techniques to stabilize H A granules have been reported. Although
surgical splints have been recommended for confinement of HA granules they do not necessarily prevent migration of HA particles TM. In our experience, the use of splints often caused pressure ulcers and secondary dislocation of granules, particularly around circum-mandibular wires. The use of a Vicryl tube increases the incidence of suture dehiscences and mucosal ulcers 14'25. The binder/filler, plaster of Paris, is insufficiently biocompatible, and its resorption results in significant condensation of H A 4'8. Pre-implantation of a subperiosteal tissue expander or acrylic resin body prevents later migration of the granules. The tissue expansion causes a widening of the connective tissue and a secondary hyperplasia of the mucosa 12. These procedures, however, require a second surgery after a few weeks. It is sometimes necessary to remove redundant granulation tissue, thus enhancing the risk of nerve damage. The fibrin sealant system has been used successfully in a variety of clinical applications including haemostasis, sealing leakages, glueing tissue, or supporting sutures. The safety
Fig. 5. Female patient aged 72 years with severely atrophic maxilla preoperative (a) and 3 years after augmentation (b).
HA-fibrin implants for ridge augmentation H
of the allogenic plasma protein with respect to transmission of viral infections (hepatitis A, non-A/non-B hepatitis, HIV) has been investigated and confirmed in a number of clinical studies 6,9,2s'3°.The fibrin network is infiltrated and resorbed by macrophages and polynuclear neutrophil granulocytes within 2 weeks H. Simultaneously, vascularized, fibroblast-rich granulation tissue grows into the spaces between the granules, replacing the fibrin links between the HA-particles. In an experimental study, collagen-
bound HA-granules induced foreignbody reactions 13 and in a clinical study 10% of the patients showed immunological reaction 22. In the present study, allogenic fibrin adhesive did not induce any inflammatory or allergic reaction. In cases of severe mandibular ridge deficiency, loss of sulcus depth is inevitable after H A augmentation. Even the use of fixed splints for 3 weeks does not prevent the need for vestibuloplasty~s. Equally, in most cases the fibrin sealant method is unable to maintain the exist-
211
ing sulcus depth. Dislocation and migration of H A granules, however, even in cases of severe atrophy, were not observed. The use of HA-fibrin adhesive in a 1:l ratio has been reported by BOCHLOGYROS et al. ~ for making preformed blocks out of H A granules. By reducing the thrombin concentration from 4 IU/ ml to 1 IU/ml and increasing the HA:fibrin ratio to 6:1, a mixture of H A granules and fibrin sealant has been developed, which can be moulded in situ according to the individual needs of pa-
212
Ho tz
tients. The fibrin binds the granules and seals periosteum ruptures. In the animal model, the distance between the fibrin-bound, polygonal HA particles remained almost constant during fibrous tissue ingrowth aS. Two factors seem to be important for the implant to retain its volume and shape and its position in extraosseous tissue: the polygonal shape of the HA granules and the temporary space maintaining of the fibrin links. WITTKAMPF32mixed autologous plasma cryoprecipitate solution containing fibrinogen and factor XIII prepared from 450 cc of the patient's blood, obtained 2 weeks previously, with HA granules in the applicator syringe. The material in the syringe was then mixed with a homologous 500 IU thrombin solution. The method has been used only for Kent classes I and II or Cawood & Howell class IV atrophic ridges, or for local defects. A splint is fixed in place for 2 weeks. With this method there is not complete control of the granules by the fibrin glue alone. This
may be due to the inconsistent quality of autologous plasma protein preparation. During the 3 years experience with fibrin sealant, this technique has proved to be most suitable for construction of shape-retaining HA-implants. No migration and displacement of particles was observed. Even under loading with a denture, which was done after 6 weeks, there was neither loss of ridge c o n t o u r nor migration of granules. Computed tomography showed that integration, i.e. fibrovascular ingrowth, of the HA granules was complete after 5 weeks and that mastication did not lead to dislocation or further condensation14. There are various further applications for mouldable fibrin-bound implants in plastic and reconstructive surgery to correct bone contour defects. Augmentation can in most cases be achieved via incisions that leave no visible scars 16. References 1. BOCHLOGYROSPN, HENSHER R, BECKER
R, ZIMMERMANNE. A modified hydroxylapatite implant material. J Maxillofac Surg 1985: 13: 213-17. 2. BOCK NJJ, Rose R. Der subperiostale Gewebeexpander als Hilfsmittel bei der Alveolarkammplastik. Dtsch Z Mund Kiefer Gesichts Chit 1987: 11: 443-7. 3. BONOMOD. Subperiostal tissue expander
for ridge augmentation. CDS Rev 1986: 4: 34-9. 4. BUSCHHE Kalziumsulfat ein Knochenersatzmittel? Dtsch Zahnfirztl Z 1985: 40: 678-80. 5. CAWOOD JT, I~OWELL RA. A classification of the edentulous jaws. Int J Oral Maxillofac Surg 1988: 17: 232-6. 6. EDER G, NEUMANNM, CERWENKAR, BAUMGARTENK. Preliminary results of a randomized controlled study on the risk of hepatitis transmission of a two-component fibrin sealant (Tissucol/Tisseel).In: SCHLAGG, REDL H eds. Fibrin sealant in operative medicine. Berlin: Springer, 1986: 51-9. 7. EDLANA. Preprosthetic surgery - a new technique in the edentulous lower jaw. Oral Surg Trans 4th Int Congress Oral Surg, Copenhagen 1973: 191. 8. FRAME JW, ROUT PGJ, BROWNE RM. Ridge augmentation using solid and po-
HA-fibrin implants for ridge augmentation H rous hydroxylapatite particles with and without autogenous bone plaster. J Oral Maxillofac Surg 1987: 45: 771-7. 9. GASTPARU. Fibrinklebung bei Patienten mit h/imorrhagischen Diathesen. In: SCI-mELE J, ed. Fibrinktebung. Berlin: Springer, 1984: 283-6. 10. H~IRLEF. M6glichkeiten und Grenzen der prfiprothetischen Chirurgie am Unterkiefer. 2. Jtg. Arbeitskreis Implantotogie, DGZMK Berlin 1985. 11. HEINEWK, ED1NGERD, BRAUNA. Wundheilung nach Fibrinkleber in Orthopfidie und Traumatologie. 4. Heidelberger Orthopfidie-Symposium. Stuttgart: Thieme, 1982: 27-34. 12. HOTZ G, FRITZ R Die Granulatfixation beim Alveolarkammaufbau mit Hydroxylapatit. Erste Erfahrungen mit einem subperiostalen Gewebeexpander. Dtsch Zahn/irztl Z 1988: 43: 85-8. 13. HOTZ G, MALL G, BORN IA, GILDE H. Kollagen und Fibrin als biologische Bindemittel ffir Hydroxylapatit-Granulat. Dtsch Z Mund Kiefer Gesichts Chir 1989: 13: 296-9. 14. HOTZ G, KRISTEN K, FRITZ P. Alveolarkammaufbau mit formbaren Implantaten aus Hydroxylapatit-Granulat und Fibrinkleber. Dtsch Z Mund Kiefer Gesichts Chir 1989: 13: 363-6. 15. HOTZ G. Alveolar ridge augmentation with hydroxylapatite using fibrin sealant for fixation. Part I: an experimental study. Int J Oral Maxillofac Surg 1991: 20:
16. HOTZ G. Konturkorrektur mit formbaren Implantaten aus Hydroxylapatitkera-
mik Fibrinklebung. In: SCHWENZERN, ed. Hefte zur Unfallchirurgie, Plastischen und Wiederherstellungschirurgie. Rotenburg, Sasse, 1991 (in press). 17. KENT JN, QUINN JH, ZIDE MF, FINGER JM, JARCHO M, ROTHSTEIN as. Correction of alveolar ridge deficiencies with nonresorbable hydroxylapatite. J Am Dent Assoc 1982: 105: 993-1001. 18. KENT JN, FINGER IM, QUINN JH, GUERm~ LR. Hydroxylapatite alveolar ridge reconstruction. J Oral Maxillofac Surg 1986: 44: 37M9. 19. KROGERE. Alveolarkammaufbau im Unterkiefer mit Hydroxylapatitkeramik. Dtsch Z Munk Kiefer Gesichts Chir 1985: 9: 194-5. 20. LAMBERTPM. A two-piece surgical splint to facilitate hydroxylapatite augmentation of the mandibular alveolar rigde. J Oral Maxillofac Surg 1986: 44: 329-31. 21. LEW D, CLARK R, SHAHBAZIANT. Use of a soft tissue expander in alveolar ridge augmentation. J Oral Maxillofac Surg 1986: 44: 516-19. 22. MEHLISCrt DR, TAWOR TD, LEIBOLD DG, et al, Evaluation of coltagen/hydroxylapatite for augmenting deficient alveolar ridges. A preliminary report. J Oral Maxillofac Surg 1987: 45:408 13. 23. OBWEGESER H. Die submuk6se Vestibulumplastik. Dtsch Zahngrztl Z 1959: 14: 629-39. 24. OSBORN JF, KAPOVITZ M, KARL P. Die zweizeitige Augmentation des atrophischen Kiefers mit Hydroxylapatitkeramik-Granulat. Coll Med Dent 1986: 30: 149-60.
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25. PAVEH-D, GERLACHKL. Ergebnisse der Kieferkammaugmentation mit Hydroxylapatit. Dtsch Zahnfirztl Z 1988: 43: 78-80. 26. PHAM H. Use of an open splint in ridge augmentation with hydroxylapatite. J Oral Maxillofac Surg 1986: 44:80 1. 27. PROPPER RH. A technique for controlled placement of hydroxylapatite over atrophic mandibular ridges. J Oral Maxillofac Surg 1985: 43: 469-70. 28. Rousou J, GONZALEZ-LAVIN L, CosGROW D, et al. Randomized clinical trial of fibrin sealant in patients undergoing restenotomy or reoperation after cardiac operations. J Thorac Cardiovasc Surg 1989: 97: 194-203. 29. STOEL1NGA PJW. Die Augmentation im Motarenbereich des Unterkiefers mit Hydroxylapatit und gleichzeitiger Sandwichosteotomie im Symphysenbereich. 2. K61ner Symposium Hydroxylapatitkeramik, K6tn 1985. 30. SUGG U. Risiko der Hepatitisfibertragung durch humanen Fibrinkleber. Dtsch Med Wochenschr 1985: 110:1161 2. 31. TERRY BC. Personal communication 1988. 32. WITTKAMPFARM. Fibrin glue as cement for HA-granules. J Cranio-Maxillofac Surg 1989: 17: 179-81. Address:
Priv.-Doz. Dr. Dr. Giinter Hotz Department of Maxillofacial Surgery University of Heidelberg Im Neuenheimer Feld 400 1)-6900 Heidelberg Germany