Lateral Ridge Augmentation Using Allograft Blocks and Guided Bone Regeneration for Implant Sites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in ridge thickness with use of the allograft block
研究概览
简要总结
Clinicians are increasingly faced with the challenge of reconstructing the alveolar ridge as more patients desire fixed implant-supported restorations. Reconstruction of large horizontal alveolar defects still remains a challenge in implantology. Although autogenous blocks from intraoral sites are proven effective for such defects, donor site morbidity and limited graft availability are major limitations. Allogenic bone blocks have been proposed to overcome these limitations, however, the outcomes reported in the literature are inconclusive. In this case series, the efficacy of allogenic blocks for lateral augmentation of atrophic ridges was evaluated, over a three-year period.
In nineteen edentulous sites from ten patients, cortico-cancellous allogenic blocks (PHOENIX, TBF, France) were shaped to the defect and screw-fixated. A double-layer of autogenous chips and demineralized bovine bone (Bio-Oss, Geistlich Pharma AG, Switzerland) was used to fill the voids. The augmented site was covered by non-cross-linked collagen membrane (Bio-Gide, Geistlich Pharma AG, Switzerland). After a healing period of 9 months, implants were placed and CBCT analysis was performed post-implantation. Following a period of 34 months of function (range 22 to 44 months), patients were clinically and radiographically re-examined.
详细描述
The present study design is a mono-center three-year follow-up case series study to examined the safety and effectiveness of allograft bone blocks combined with guided bone regeneration (GBR). The study was in accordance to the principles of the Declaration of Helsinki and was approved by the standing ethical committee of the state of Bern, Switzerland.
The preoperative analysis included a complete medical history, clinical examination of the dentition and a thorough analysis of the implant recipient using 3D cone beam computed tomography (3D Accuitomo 170, Morita, Kyoto, Japan).
Surgical Procedure:
The surgical procedures were done in two stages. In the first stage surgery, a full-thickness mucoperiosteal flap was raised on both the facial and palatal aspects. Ridge augmentation was done using a mineralized, cortico-cancellous, delipidized, lyophilized allogenic block (ALB ; PHOENIX allograft, TBF Mions, France). Following hydration of the ALB, the cortico-cancellous part of the block was shaped to fit the recipient site and fixated by two fixation screws (Medartis, Modus, Medartis Holding AG, Basel, Switzerland). Voids around the ALB were filled with autogenous bone chips (AGB) harvested locally from the recipient site. The augmented site was covered by a first layer of deproteinized bovine bone mineral mixed (DBBM; Bio- Oss, Geistlich Pharma, Wolhusen, Switzerland and a non-crosslinked collagen membrane (BG; Bio- Gide, Geistlich AG, Wolhusen, Switzerland) as described previously (Chappuis et al DOI 10.1111/cid.12438). A periosteal-releasing incision was used to provide tension-free flap closure. The wound margins were approximated using non-resorbable poly- amide suture (Seralon, Serag-Wiessner GmbH, Naila, Germany) to obtain primary wound closure. All patients were prescribed an antibiotic regimen with 2g of amoxicillin with clavulanic acid 1 hour preoperatively to be continued as 1g twice daily for 3 days post-surgery. Patients were also prescribed analgesics and chlorhexidine digluconate (0.2%) for chemical plaque control. In patients with post-surgical complications the antibiotic regimen was prolonged. Sutures were removed around 14 days postoperatively. Removable provisionals were adapted, but patients were instructed to not to wear them unless unavoidable during the initial healing phase.
The second stage surgery was performed after a minimal healing period of six months (range 6 to 13months for me this would belong to the results). A paracrestal incision was given to elevate a full thickness mucoperiosteal. The fixation screws from the previous surgery were removed and the implant bed was prepared based on the specific requirements of the site. All implants placed had chemically modified, sandblasted, and acid-etched surface and had either, a tissue level implant (TL) or a bone level implant (BL) design (SLActive, Straumann AG, Basel, Switzerland). Simultaneous re-grafting was performed as required using autogenous bone chips, DBBM and a non-cross linked collagen membrane. A tension-free wound closure was obtained by non-resorbable sutures. The antibiotic and analgesic regimen and post-surgical care as the same as in the first-stage surgery. Sutures were removed after 14 days. Patients were instructed to wear the provisional with caution. After the healing period of 4-6 months the healing abutments were placed for the future prosthetics. The implants were restored with either single-unit crowns (SC), crowns with extensions (SC-E), bridges (B), bridges with extensions (B-E) or ball abutments (BA). All restorations were screw-retained. Patient were given oral hygiene instructions and directed to enroll onto a supportive periodontal therapy to monitor oral health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Atrophy of the alveolar ridge in the horizontal plane (<4 mm in posterior sites and <5 mm in anterior sites), or a crest width 5 mm in esthetic sites.
- •Patients who agree to sign an informed consent.
排除标准
- •Patients who had adequate horizontal ridge thickness and did not require ridge augmentation
- •Patients with deficient vertical height of the ridge requiring vertical augmentation
- •Patients who were not ready for implant supported prosthesis
研究组 & 干预措施
Allograft block graft
For lateral alveolar ridge augmentation, all patients will be treated with allograft block with guided bone regeneration. After a minimal healing phase of six months, implants would be placed in the augmented site. After a healing phase of about 4months, the implants would be loaded and then followed until the control appointment approximately 3 years later.
干预措施: Allograft block graft (Device)
结局指标
主要结局
Change in ridge thickness with use of the allograft block
时间窗: The measurements were done at approximately 9 months after ridge augmentation surgery and prior to implant placement.
The change in ridge thickness was measured in mm at a specific reference point 4mm apical to the shoulder of the implant. The measurements were done from a CBCT image in the coronal/sagittal plane.
Change in ridge thickness with use of the allograft block after implant placement
时间窗: The measurements were done at the follow-up appointment approximately 3years after implant placement.
The change in ridge thickness was measured in mm at a specific reference point 4mm apical to the shoulder of the implant. The measurements were done from a CBCT image in the coronal/sagittal plane.
次要结局
- Modified sulcus bleeding index by Mombelli(Recorded at the 3years follow-up time point)
- Probing depth(Recorded at the 3years follow-up time point)
- Peri-implant suppuration(Recorded at the 3years follow-up time point)
- Mobility(Recorded at the 3years follow-up time point)
- Modified plaque index by Mombelli(Recorded at the 3years follow-up time point)
- Width of the keratinized mucosa(Recorded at the 3years follow-up time point)
- Number of participants with post implant surgery complications(One day after to 6 months post implant surgery)
- Visual Analog Scale(3 years afer implant placement)
- Distance from the implant shoulder to the mucosal margin(Recorded at the 3years follow-up time point)
- Number of participants with intraoperative complications at graft surgery(During graft surgery)
- Number of participants with post graft surgery complications(One day after to 6 months post graft surgery)
- Oral Health Impact Profile 14(3 years after implant placement)
- Full mouth plaque scores(Recorded at the 3years follow-up time point)
- Number of participants with intraoperative complications at implant surgery(During the implant placement surgery)
- Number of patients with technical complications(One day after to 3 months post prosthetic rehabilitation)