to oral implant reconstruction Bradley S. McAllister & Thomas E. Gaffaney Distraction osteogenesis has been employed in the lengthening of long bones for the last 100 years (8). During the last 50 years, predictable results having been developed through scientic studies by the Russian surgeon, Gavriel Ilizarov (1619). The basic principle developed by Ilizarov has the following three distinct phases: a latency phase of approximately 7 days of initial post surgical healing; the distraction phase, consisting of the gradual incremental separation of two bone pieces at a rate of approximately 1 mm per day; consolidation phase, during which new bone forms in the regenerate zone between the separated bone pieces. Over the last 7 years the technique of distraction osteogenesis has been under development for verti- cal augmentation of the mandible and maxilla prior to implant reconstruction (6). With such a short his- tory of employing alveolar distraction for the specic application of implant reconstruction, the technique is clearly still in its infancy. Yet, one must not lose track of the fact that the general principle of distrac- tion osteogenesis has been extensively investigated and successfully applied to a variety of bone pro- blems over the last century. While no controlled long-termstudies exist with any of the commercially available alveolar bone devices available today, excellent case reports and animal stu- dies exist for the distraction devices currently avail- able. These publications demonstrate the potential for successful results with a variety of intraosseous and extraosseous distractors. The rst published case report of alveolar bone distraction was that of a single mandibular case using an intraosseous distractor with a threaded rod, a threaded transport plate and a sta- bilizing unthreaded base plate (6). Additional case reports have been published over the past few years with intraosseous, extraosseous and implant distrac- tors (4, 10, 15, 21, 24, 34). Recently, a case history review of prosthetically restored distraction cases, loaded for a minimum of 3 years, revealed a success rate of 90.4% for the 84 implants placed in distracted bone utilizing devices that are not commercially avail- able (20). This high rate of success compares favorably with other reports evaluating rates of oral implant success in regenerated bone (14). Several animal studies have been published demon- strating successful vertical augmentation. Customized ossseointegrated implant supported distraction dev- ices were utilized in dog mandibles to gain 9 mm of vertical augmentation. The regeneratedbone was eval- uated histologically (2, 3). The distraction gap, or regenerate zone, was lled with new bone and both a lingual and buccal cortex were formed. The crestal bone levels did not change during a year of implant loading (3). Additional dog studies by Oda and collea- gues have evaluated botha two-stage andsingle-phase approach to implant placement (27, 28). In the single stage approach, implants were used as the distraction device and left to integrate (27). While the regenerated bone in the distraction gap was found to consist of a comparable percent of bone area, 20% of the implants failed to integrate, minimizing the clinical validity of this approach. Their more successful two-stage approach utilized a simple intraosseous screw for active distraction. Implants were placed during the consolidation phase and evaluated at 12 weeks. Less than 1 mm of crestal loss was found and minimal differences were noted between the transport segment and the regenerated bone for both percent bone area and percent bone-to-implant contact. 54 Periodontology 2000, Vol. 33, 2003, 5466 Copyright # Blackwell Munksgaard 2003 Printed in Denmark. All rights reserved PERIODONTOLOGY 2000 ISSN 0906-6713 Studies using in vitro techniques to gain a better understanding of the phenomenon of distraction osteogenesis have evaluated how osteoblasts respond to mechanical stimulation. Elevations ingrowthfactor and cytokine gene expression have been demonstra- ted in response to the mechanical stimulation in vitro (7). Together with the extensive animal studies in long bones and the numerous craniofacial applications (25, 32), the principle of distraction osteogenesis is now a part of the periodontist's armamentarium for implant placement. Surgical technique of distraction osteogenesis Proper treatment planning is imperative for distrac- tion osteogenesis. Typically, for distraction to be considered, a minimum of 67 mm of bone height must remain above vital anatomic structures and at least a 4 mm vertical defect of sufcient length (edentulous zone of three or more missing teeth) must exist when measuring from the height of the adjacent bony walls to the vertical depth of the oss- eous defect. In the event teeth adjacent to the eden- tulous region being considered for distraction show considerable marginal bone loss, it is reasonable to consider extraction and extension of the edentulous zone to create a true vertical defect of at least 4 mm depth. With no evidence existing that the attachment level on teeth can be improved through distraction, it may be necessary to sacrice a compromised tooth to optimize the amount of vertical bone improve- ment. In fact, in animal studies, attempts to improve the attachment level on natural teeth with distraction were unsuccessful (1). Small vertical defects of only one or two teeth tend to have a higher rate of com- plication when distracted and should usually be trea- ted with conventional bone grafting techniques (20). While it is desirable to perform distraction under conscious sedation or general anesthesia, it is possi- ble to perform the surgical procedure using only regional anesthesia. Either a vestibular mucosal inci- sion or a mid-crestal incision placed at the buccal line angle staying in gingival (keratinized) tissue may be successfully utilized to access the bone (22, 24). A full thickness ap is elevated on the buccal aspect only, taking care not to reect the tissues on the alveolar crest or towards the lingual. The horizontal and vertical osteotomies are prepared with either a ssure bur, or a saw, taking great care not to damage the lingual periosteum. The specic order of distrac- tor placement, distractor xation and nal osteot- omy preparation is specic to the system being used. Once the distractor is placed and the osteo- tomies are complete, device function is tested to make sure that there are no interferences. If the ver- tical osteotomies slightly converge to the coronal, and to the lingual aspect, there will be little risk for interference problems. Suturing can be easily accom- plished by primary closure using a slowly resorbing suture material such as vicryl. A 1-week latency healing period should be employed prior to initiation of distraction. In young patients with rapid healing, a shorter period may be utilized. In older patients, or those with slow soft tissue healing, a slightly longer latency period may be utilized. With complete soft tissue closure, dis- traction may be initiated at a rate of up to 1 mm per day. A slower rate of distraction may be utilized in older individuals and in cases of dense bone with minimal vascularity. It is important to optimize the incremental traction for proper tension stress and ultimate osseous healing. While continuous distrac- tion, or incremental movement over multiple daily advancements, has been shown to improve the bone regeneration it is not clear what the optimal rate and frequency is for alveolar distraction (16, 19, 30). A reasonable approach for alveolar distraction would be to have the patient turn the device three times daily for incremental advancements of 0.25 to 0.33 mm. Optimal bone formation was found to occur at physiologic levels of 2,000 microstrain with some decreases in hydroxyapatite crystal formation by 20,000 microstrain/one cycle per day. Only brous tissue was formed in specimens distracted with the hyperphysiologic levels of 200,000 and 300,000 microstrain, indicating the importance of not placing excessive tension on the tissues (26). Meyer et al. (26) also demonstrated that peak strain magnitudes rather than frequency inuence the bone cell differentiation and matrix production, indi- cating smaller more physiologic advances, even if frequent, will likely optimize the bone regeneration. While some slight crestal resorption is often found during consolidation, it usually is no further apical than the adjacent bone levels. Therefore, it may be benecial to overdistract by 23 mm. Any further overcorrection may minimize the potential for bone-to-bone contact between the vertical osteo- tomies and the transport segment resulting in a higher incidence of non-union or incomplete dis- traction gap ossication. Distractor removal and implant placement will be performed during the consolidation phase. It is pos- sible to place implants at the time of distractor Distraction osteogenesis 55 removal, or it may be benecial to delay placement until further hard and soft tissue consolidation has occurred. The decision should not only be based on how the area is healing, as determined clinically and radiographically, but also on the position of the pro- posed implant. In partially edentulous cases the implant treatment plan typically consists of placing implants in the locations of the vertical osteotomies, indicating the need to have adequate consolidation to prevent segment mobilization during implant osteotomy preparation, or actual implant placement. In a signicant number of distraction cases supple- mental bone and soft tissue grafting may be required to optimize the nal result (20, 23, 24). As a minimum timeline for consolidation, the long bone literature has suggested 5 days per 1 mm of distraction (29). Standard integration periods consistent with newly regenerated bone should be employed prior to pros- thetic loading of the dental implants placed in dis- tracted bone. ACE surgical distractor The intraosseous ACE distractor (ACE Surgical Sup- ply, Brockton, MA) is made of titanium alloy and has three main components during active distraction (Fig. 1). The distractor body engages the bony trans- port segment with external threads that are of the same pattern as that of a conventional 3.75 mm oral implant. The distractor body comes in both a 5 mm thread length (long body) and a 3 mm thread length (short body). Unless anatomic constraints exist, it is advisable to utilize the long body distractor for max- imal xation. The axial distraction screw is threaded through the distractor body and used for active dis- traction. The base plug has an internally threaded hole in which the axial distraction screw sits and engages for the distraction process. As the axial dis- tractor screw is turned in a clockwise direction (2.5 turns/1 mm), the upper distractor body with the bony transport segment advances in a coronal direction away from the intact bony bed with the stationary base plug. This distraction system has a very simple removal procedure that does not require mucoperiosteal ap reection unless implants are placed at the time of the distractor removal surgery. At distractor removal the base plug is easily removed by threading the base plug removal tool onto the internal threads of the base plug. Reports to date with this system have shown favorable results (21, 24, 34). The following examples illustrate the capabilities of this intraosseous distractor. A 42-year-old male presented for oral implant reconstruction following a motor vehicle accident. A signicant vertical defect was present in the area of missing teeth 32 through 41 (Fig. 2). After horizontal osteotomy preparation, the distractor was placed. Once distractor stability was conrmed, vertical osteotomies were completed utilizing a straight ssure bur (Fig. 3). After a 1-week latency period, distraction was initiated at the rate of 1 mm/day for 8 days utilizing guidance components Fig. 1. ACE distractor components during activation. The axial distraction screw is shown during activation with the 0.88 mm hex driver. A long body distractor with an axial distraction screw and base plug is shown. 56 McAllister & Gaffaney and an appropriate temporary (Fig. 4). Without mucoperiosteal ap reection the distractor was removed after 2 months of consolidation. After a total of 4.5 months of consolidation two implants were placed and a biopsy was taken from the regen- eration zone (Figs 5 and 6). After a standard integra- tion period the implants were restored and loaded. Fig. 2. Radiographic view of the vertical bone loss. Fig. 3. The segment after placement of the distractor and completion of both the horizontal and vertical osteotomies to mobilize the segment. Fig. 4. Radiographic view at the completion of approxi- mately 8 mm of distraction. Fig. 5. Two 18-mm implants have been placed and a biopsy was taken from the regeneration zone. 57 Distraction osteogenesis Radiographic and clinical evaluation after 3 years shows excellent preservation of bone and soft tissues (Fig. 7). A 36-year-old female presented with teeth 32 through 43 lost from untreated aggressive periodon- titis. The 6 mm vertical defect that remained (Fig. 8) was treated with two distractors (Fig. 9). For this system, one distractor is typically placed for every three missing teeth up to a maximum of three dis- tractors. Following 2 months of consolidation, imp- lants were placed at the time of distractor removal and allowed to heal for 7 months prior to nal restoration (Fig. 10a,b). As with most distraction systems, it is imperative that the guidance components and a suitable Fig. 6. Regeneration zone biopsy. (a) The entire histologic specimen (original magnication 3). (b) Magnied view of an area containing immature woven bone (original magnication 40). (c) Magnied view of an area contain- ing more mature lamellar bone (original magnication 40) (Stevenel's blue Van Gieson's picric fuchsin stain). Fig. 7. The radiographic view of the distraction case after 3 years. Fig. 8. Surgical view after the reection of only the buccal mucoperiosteal ap prior to the placement of two ACE distractors. 58 McAllister & Gaffaney temporary be utilized to insure proper transport seg- ment positioning. Base plug instability may arise during placement of the ACE distractor, especially if an insufcient amount of bone remains apical to the base plug. Due to the dense inferior cortex of the mandible, planned vertical distraction can be achieved even with complete disattachment of the base plug. Currently, the preassembled device con- tains both the base plug and the distractor body, so instability is not likely to occur. Radiographic con- rmation at the completion of surgery and during distraction is advised to conrm proper positioning of the distractor components. The Leibinger Endosseous Alveolar Distraction (LEAD) system The intraosseous LEAD system (Stryker Leibinger, Kalamazoo, MI) consists of a 2 mmdiameter threaded rod, a threaded transport plate, and a stabilizing unthreaded base plate (Fig. 11). The threaded distrac- tionrodcomes in17, 22 and32 mmlengths andcanbe advanced0.4 mmper turn. The angle of the osteotomy preparation for the threaded rod should be consistent with the proposed vector of distraction. The transport plate and base plate are then bent and xed into place with xation screws to maintain the proposed vector (Fig. 12). With the signicant forces from the palatal tissues and lingual musculature it is advisable to use a guidance temporary toensure the transport segment is Fig. 9. Radiographic view at the completion of approxi- mately 8 mm of distraction with 2 mm of overcorrection. The guidance axial distraction screwis engaging the ortho- dontic band retained lingual arch wire xed/removable temporary. Fig. 10. The nal restoration after consolidation (a, b). 59 Distraction osteogenesis orientated correctly with this system (Figs 13 and 14). With the narrownature of the threaded rod it is impor- tant not to apply too much horizontal force as bone resorption can occur and the rod may become dis- placed from the transport segment. With the narrow threaded rod a vestibular incision can be made and drilling the threaded rod osteotomy can be made with- out mucoperiosteal ap reection even in cases with narrow ridges. It is, however, still necessary to later augment the ridge in the horizontal direction if it has not been completed prior to distractor placement. Reports to date with this systemhave shown favorable results (6, 12, 13). KLS Martin distractor The extraosseous Track distractors (KLS Martin, Jack- sonville, FL) are made of titanium with microplates that have been welded onto the sliding mechanism of the actual distraction screw (Fig. 15). Multiple sizes are available depending on the regenerative needs. For full arches the Track 1.5 is indicated and for very small segments the Track 1.0 microdistractor may be utilized. For most partially edentulous distraction patients the Track Plus distractor is indicated, because it has the most rigidity due to the apical extension and it is still of manageable size. Fig. 11. The LEAD system showing the threaded rod, sta- bilizing base plate and threaded transport plate. Fig. 12. The LEAD system xated in place after the com- pletion of the horizontal and vertical osteotomies. Fig. 13. The ridge as seen prior to the start of distraction. Fig. 14. After the completion of distraction the coronal advancement of the transport segment can be appreciated. 60 McAllister & Gaffaney The following case study demonstrates how this extraosseous distractor functions. A 41-year-old male presented following untreated trauma that fractured teeth 11 and 21. Secondarily this resulted in 75% bone loss on the mesial and facial aspects of tooth 12 (Fig. 16). The patient was a smoker, but had no other medical issues. All three hopeless teeth were extracted. A graft of anorganic bone (Bio-Oss, Osteo- health, Shirley, NY) was placed and the area was allowed to heal for 5 months. After a vestibular inci- sion was made, a Track Plus device was modied to t the bony topography of the area and screwed to place. The locations for vertical and horizontal osteo- tomies were marked, the device removed, the osteo- tomies completed with saws and the device was replaced with additional xation screws (Fig. 17). After a 1-week latency healing period, distraction was initiated at a rate of approximately 1 mm/day (1 turn for 0.3 mm). Concurrent with completion of distraction, excellent vertical height was obtained (Fig. 18). However, some soft tissue dehiscence of the distraction device was noted at the end of the consolidation period (Fig. 19). With extraosseous devices, soft tissue complications may occur more frequently due to the compromised blood supply, yet this does not appear to affect the osseous outcome as long as soft tissue grafting is completed at the time of distractor removal. After 5 months of consolidation, the distractor was removed, a soft tissue graft was added, and implants placed (Fig. 20). After 4 months of further healing, a provisional implant supported restoration was placed (Fig. 21). Fig. 15. The KLS distractors: (a) Track 1.5, (b) Track Plus and (c) Track 1.0. Fig. 15. continued 61 Distraction osteogenesis With the extraosseous distractors there is no bone width requirement; however, ultimate implant reconstruction requires a 57-mm-wide ridge. Thus, grafting with autogenous bone to achieve the neces- sary width may be necessary prior to distraction. A split ridge approach for increasing the ridge width is the suggested approach prior to distraction (9, 31). While the potential for nerve injury exists for any posterior mandible distraction case, the extraosseous design is the best suited for this region (Fig. 22). An insufcient number of patients have been treated for a predictive incidence of nerve damage from the distraction osteotomies in this area to be deter- mined. The small number of surgeries performed in this area is likely due to the limited number of indications for distraction in this area. A minimum of 56 mm bone is required superior to the nerve to allow for clearance with the nerve during horizontal osteotomy preparation and to maintain a transport segment height of 34 mm. For any amount less than this 56 mm, nerve repositioning should be Fig. 16. Initial radiographic appearance showing exten- sive evidence of bone loss on teeth 12, 11 and 21. Fig. 17. The KLS Martin Track Plus fully xated with completed vertical and horizontal osteotomies prior to suturing. Fig. 18. Radiographic appearance at the completion of 6 mm of distraction. Fig. 19. At the end of the consolidation phase, excellent vertical height can be appreciated. 62 McAllister & Gaffaney considered, or no implant placement and use of an alternative prosthetic replacement. Considering that when 8 mm of bone height is present above the nerve 10 mm implants can usually be placed with minimal particulate vertical guided bone regenera- tion. Therefore only those cases with 57 mm of bone superior to the nerve should be considered for distraction, leaving a fairly small number of actual cases. Reports to date with this extraosseous system have shown favorable results (4, 15). Distractor and oral implant combination devices The concept of a prosthetically restorable distractor (Fig. 23) was introduced by SIS Trade Systems (Kla- genfurt, Austria). A histologic study in sheep has demonstrated that this distractor becomes osseoin- tegrated and can therefore function as a loaded oral implant (11). A study in 35 patients evaluating these distraction implants found a range of 46 mm increase in vertical height and no complications in 29 of the 35 patients (10). Conceptually, this approach is clearly superior because the secondary surgeries for distractor removal and implant place- ment are eliminated. There are, however, several major complications of concern that could arise spe- cic to this approach, including a lack of device osseointegration, improper device orientation for restoration, crestal bone loss during distraction exposing the rough coronal device threads, and the inability to initially place the devices in ideal pros- thetic position due to the interference of the vertical osteotomies. The Veriplant distraction device Fig. 20. Radiographic presentation at the time of implant placement. Fig. 21. After integration, a provisional implant supported restoration has been placed. Fig. 22. Distraction in the posterior mandible with a KLS Martin Track Plus. Fig. 23. The SIS implant distractor in the start position (left) and in full extension (right). 63 Distraction osteogenesis (EverFab, East Aurora, NY) is also a combination oral implant and distractor device (33). Potential complications with distraction osteogenesis While the complication rate for distraction is fairly low, a variety of complications such as infection, extensive bleeding, nerve injury, adjacent tooth damage, and ap dehiscence may occur. If the per- iodontist is not prepared for the potential complica- tions the treatment will more likely result in an unfavorable outcome. With proper treatment plan- ning and careful surgical manipulation, most of these complications can be avoided. In addition to general surgical complications, there are several potential complications related to the alveolar distraction pro- cedure itself. Fracture of the host bone or transport segment may occur during insertion of the distraction device, or distraction xation screws. This is most often a concern in narrow ridges of dense bone quality when the transport segment dimensions are small. As a result of fracture, the distractor, or distractor xation screws, will lose stability and therefore should be removed. In cases with insufcient distractor stabi- lity it may be appropriate to remove the distractor, place a bone graft and delay distraction surgery for 2 3 months. In order to prevent fracture of dense bone, tapping is recommended during the ACE distractor insertion. This avoids stress on the buccal plate of the transport segment. For the distractors using a micro screw xation system, a larger diameter drill before placement may minimize damage to a transport seg- ment with dense bone. Care should also be taken if completion of the osteotomies is performed with an osteotome, particularly near the maxillary sinus oor and the piriform rim. It is recommended that only the lateral walls be used for leverage of the transport segment during mobilization. Distractor instability can develop due to poor bone quality, soft tissue dehiscence, transport or host seg- ment fracture, or extensive site preparation for dis- tractor placement. Placing the ACE distractor apical enough to engage the wider implant shoulder will increase distractor stability. Using longer or wider diameter xation screws for situations of question- able KLS or LEAD distractor stability can also improve xation. If adequate distractor stability can- not be obtained, the distractor must be moved to a different location, or the site must be closed for later distraction. Either with a single distractor or multiple distrac- tors, undesirable movement of the transport bone segment may occur, often due to lingual ap or mus- cle tension. A guidance axial distraction screw may be utilized to maintain the desired direction of move- ment or to correct malalignment with the ACE dis- tractor. Temporary or orthodontic hardware may be used with the KLS or LEAD distractors if segment guidance is an issue. Making the lingual aspect of the vertical cuts slightly convergent will also resist undesirable segment movement, especially when lar- ger transport segments are used that involve more arch curvature. When both vertical osteotomies are properly com- pleted and the distraction rate is kept to 1 mm per day or less, the transport segment should advance without signicant resistance. If premature consolidation occurs prior to completion of distraction, it is likely due to incomplete osteotomy or mineralization at the vertical osteotomy sites. In these cases, the transport segment can be freed under local anesthesia by apply- ing a nger pressure on the bone segment. Alterna- tively, the transport segment premature consolidation can be re-osteotomized using a small-size interdental osteotome through a small incision. Keeping the ver- tical osteotomies slightly divergent to the crestal aspect will prevent segment binding and minimize premature consolidation. Typically, there is no detectable transport segment mobility at the end of the consolidation period. In some cases, however, delayed consolidation may occur, potentially leading to the development of a nonunion. If signicant transport segment mobility exists at the proposed time of distractor removal, the device may be left in place to allow further consoli- dation. Sufcient stabilization of the transport seg- ment is an important aspect in prevention of nonunion during distraction. During active distrac- tion and during the consolidation phase, segment mobility must be controlled. In cases with an imma- ture regeneration, nger pressure can be applied to the transport segment at the time of distractor removal to resist rotational forces, thereby stabilizing the segment. In addition, immediate placement of oral implants at this point will also support further stabilization of the newly regenerated bone. Finally, if a partial or complete nonunion exists at the nal uncovering of the implants, debridement must be performed followed by bone grafting and plate sta- bilization. While any of these complications are possible, the publications to date indicate these complications occur at a very low rate (4, 5, 12, 13, 20, 22). For 64 McAllister & Gaffaney distraction cases involving sites that have had multi- ple prior surgeries the incidence of complications is higher (5), suggesting that distraction should be the rst line of treatment rather than a last resort after other techniques have failed. Considering there is no established ideal bone augmentation approach for the treatment of vertical defects, the minimal inci- dence of complications gives further support to the technique of distraction osteogenesis for treatment of vertical defects. 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