Radiographic And Histomorphometric Assessment Of Guided Bone Regeneration Using Xenograft Mixed With Allogenic Bone Graft Versus Xenograft Mixed With Autogenous Bone Graft For Augmentation Of Deficient Maxillary Alveolar Ridges A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Bucco-Palatal horizontal bone gain
研究概览
简要总结
This study aims to evaluate the effect of Allogenic bone graft mixed with Xenograft in ratio 1:1, on the radiographic and histomorphometric assessment versus Autologous bone graft mixed with Xenograft in ratio 1:1 in maxillary deficient ridges، In guided bone regeneration of deficient edentulous maxillary ridges, will the application of Xenograft mixed with Allograft (1:1) be as effective as Xenograft mixed with Autogenous graft (1:1) in terms of dimensional ridge changes and Quality of newly formed bone?
Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene and pathological conditions.
A full thickness flap will be elevated with two releasing incisions, decortication of the buccal aspect of the ridge, placing of grafting material which will be covered by collagen pericardium membranes, tacks placement at the labial side to fix the membrane in place, horizontal mattress sutures as well as single interrupted and continuous with resorbable sutures for closure.
Intervention group: will be filled with mixture of Xenogenic graft and the Allogenic bone graft chips.
Control group: will be filled with mixture of Xenogenic graft and Autogenous bone particulate harvested either the ramus.
For both groups, All the subjects will be taking CBCT at pre surgical and 6 months post surgical. outcomes : Bucco-Palatal horizontal bone gain, Alveolar ridge height, Percentage of new vital bone formation and Percentage of residual bone graft 6 months post-surgical.
详细描述
This study aims to evaluate the effect of Allogenic bone graft mixed with Xenograft in ratio 1:1, on the radiographic and histomorphometric assessment versus Autologous bone graft mixed with Xenograft in ratio 1:1 in maxillary deficient ridges. Null hypothesis: no significant difference in ridge dimensional changes is expected to occur on comparing Xenograft mixed with Allograft versus Xenografts mixed with autogenous bone grafts in guided bone regeneration.
The study will be conducted at the post-graduate clinic of the periodontology and Oral Implantology Departments, Faculty of Dentistry, Cairo University, Egypt. Patients will be selected from the outpatient clinic of the Department of Oral Implantology, Cairo University.
- Clinical examination & informed consent: Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene and pathological conditions.
- Radiographic examination: Preoperative cone beam computed tomography (CBCT) will be done to exclude any pathosis and measure the bone width of the deficient area. Bone width will be measured from the reformatted cross-sectional image of the CBCT 2.0 mm below the tip of the crest at every single deficient site taking a specific anatomical landmark in the opposing teeth as a reference point for the measurements taking into consideration that the patients are biting in maximum intercuspation. The average of these measurements will be calculated to be a representative value of the preoperative width for each case from the preoperative CBCT. Immediate and 6 months postoperative CBCT will be done with the patients biting in maximum intercuspation and the same measurements will be taken from the same reference areas that were previously selected from the preoperative scan. Alveolar height will be measured from crest of the ridge to the nasal floor or sinus floor.
- Surgical procedures: Local anesthesia will be administered by infiltration or nerve block to achieve the necessary anesthesia and guided bone regeneration will be done according to the allocation concealment.All procedures will be performed by the same surgeon.As a prophylactic measure all patients will receive 2 g of V-penicillin amoxicillin/clavulanate 2 g for 10 days starting 1 hour pre-operatively or Clindamycin 300 mg for 10 days in event of penicillin allergy.
A full thickness flap will be elevated with two releasing incisions extending at least just distal to each tooth adjacent to the defect site. vertical incisions at the canine eminence will be avoided and instead extended distal to the canine to avoid future dehiscence at this site. The flap will be reflected adequately to expose the defect. The cortical bone will be perforated with a small round bur to perform decortication of the buccal aspect of the ridge.
Control group (Xenograft + Autogenous bone) Autogenous bone particulate will be harvested either from the mandibular ramus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of the participants and the operator is not applicable, however outcome assessors and bio-statistician will be blinded.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 20-50 years.
- •Totally or partially edentulous maxillary ridges.
- •Patients with insufficient bone for an implant placement.
- •Residual alveolar width ranging from 2 to 4 mm.
- •Minimum of 10 mm vertical dimension to nasal floor or sinus floor.
- •Patients with healthy systemic condition (Medically free).
- •Adequate inter-arch space for placement of the implant prosthetic part.
排除标准
- •Pathological lesions in the defect site.
- •Systemic diseases that would interfere with bone metabolism. Uncontrolled diabetic patients.
- •Ongoing treatment or a history of recent chemotherapy or radiotherapy.
- •Patient with medical condition that contraindicates surgical procedures.
- •Patients on medication that may interfere with healing (Corticosteroids, Bisphosphonate, Chemo/radio therapy).
- •Patients with vertical bone deficiency.
- •Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or para-functional habits.
研究组 & 干预措施
Allogenic bone graft mixed with Xenograft in ratio 1:1
A full thickness flap will be elevated with two releasing incisions extending at least just distal to each tooth adjacent to the defect site.The flap will be reflected adequately to expose the defect. The cortical bone will be perforated with a small round bur to perform decortication of the buccal aspect of the ridge. recipient site will be debrided from any soft tissue or periosteum remnants.The grafts will be placed on the buccal aspect of the alveolar ridge, layer by layer, gently pressed to the recipient site then it will be covered by a collagen pericardium membranes. The membrane will be stretched tightly over the graft and titanium tacks will be placed at the labial side to fix the membrane in place. The incisions will be carefully closed with horizontal mattress sutures as well as single interrupted and continuous with resorbable sutures.
干预措施: Allogenic bone graft mixed with Xenograft in ratio 1:1 (Biological)
Autologous bone graft mixed with Xenograft in ratio 1:1
A full thickness flap will be elevated with two releasing incisions extending at least just distal to each tooth adjacent to the defect site.The flap will be reflected adequately to expose the defect. The cortical bone will be perforated with a small round bur to perform decortication of the buccal aspect of the ridge. recipient site will be debrided from any soft tissue or periosteum remnants.The grafts will be placed on the buccal aspect of the alveolar ridge, layer by layer, gently pressed to the recipient site then it will be covered by a collagen pericardium membranes. The membrane will be stretched tightly over the graft and titanium tacks will be placed at the labial side to fix the membrane in place. The incisions will be carefully closed with horizontal mattress sutures as well as single interrupted and continuous with resorbable sutures.
干预措施: Autologous bone graft mixed with Xenograft in ratio 1:1 (Biological)
结局指标
主要结局
Bucco-Palatal horizontal bone gain
时间窗: 6 months postoperatively
Bone width will be measured from the reformatted cross-sectional image of the CBCT 2 mm below the tip of the crest at every single deficient site taking a specific anatomical landmark in the opposing teeth as a reference point for the measurements taking into consideration that the patients are biting in maximum intercuspation. The average of these measurements will be calculated to be a representative value of the preoperative width for each case from the preoperative CBCT. Immediate and 6 months postoperative CBCT will be done while the patients are also biting in maximum intercuspation and the same measurements will be taken from the same reference areas previously selected from the preoperative scan.
Bucco-Palatal/Lingual horizontal bone gain
时间窗: 6 months postoperatively
Bone width will be measured from the reformatted cross-sectional image of the CBCT 2 mm below the tip of the crest at every single deficient site taking a specific anatomical landmark in the opposing teeth as a reference point for the measurements taking into consideration that the patients are biting in maximum intercuspation. The average of these measurements will be calculated to be a representative value of the preoperative width for each case from the preoperative CBCT. Immediate and 6 months postoperative CBCT will be done while the patients are also biting in maximum intercuspation and the same measurements will be taken from the same reference areas previously selected from the preoperative scan.
次要结局
- Alveolar ridge height:(6 months postoperatively)
- Percentage of new vital bone formation(6 months postoperatively)
- Percentage of residual bone graft(6 months postoperatively)
研究者
Mohamed Abdulnaser Abousetta
Master Degree student, Implantology department, Faculty of Dentistry, Cairo University
Cairo University