“Comparative evaluation of the effectiveness of bioresorbable collagen membrane in combination with deproteinized bovine bone matrix xenograft and advanced platelet rich fibrin membrane in combination with deproteinized bovine bone matrix xenograft for periodontal regeneration in human infrabony defects: A clinical and radiographic studyâ€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Radiographic bone fill
研究概览
简要总结
Introduction: Periodontitis is a chronic, multifactorial, inflammatory disease that leads to gradual loss of bone and periodontal attachment. Thus, periodontal surgery is required according to severity of diseases. The goal of periodontal reconstructive surgery is to regenerate soft and hard tissues destroyed during periodontal disease.
Aim: To compare the effectiveness of Bioresorbable Collagen Membrane in combination with Deproteinized Bovine Bone Matrix xenograft and Advanced Plasma rich fibrin(A-PRF) membrane in combination with Deproteinized Bovine Bone Matrix xenograft in the treatment of human infrabony defects.
Methods and Materials: This randomised controlled trial will be carried out at the periodontics outpatient department. We will choose 24 patients with moderate to advanced chronic periodontitis who are also systemically healthy. Infrabony defects will be treated by open flap debridement using bovine-derived xenograft and bioresorbable collagen membrane (group A) and open flap debridement using bovine-derived xenograft and A-PRF after the completion of first therapy (group B). At baseline and six months after undergoing periodontal surgery, probing pocket depth, clinical attachment level, radiographic bone fill, gingival recession, oral hygiene status, and gingival health were measured.
Expected Results: Bioresorbable Collagen Membrane and Advanced-Platelet Rich Fibrin Membrane in Combination with Deproteinized Bovine Bone Matrix Xenograft will lead to decrease in PPD, increase in CAL and better radiographic bone fill in infrabony defects.
Conclusion: It is suggested that Bioresorbable Collagen Membrane in combination with Deproteinized Bovine Bone Matrix xenograft will show better results as compared to Advanced Platelet Rich Fibrin Membrane with Deproteinized Bovine Bone Matrix Xenograft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •â€œPresence of at least 1 or 2 radiographically detectable interproximal infrabony osseous defect with probing pocket depth ≥ 5 mm and clinical attachment loss ≥ 5 mm following initial therapy.
- •Depth of intraosseous component of the defect ≥ 3 mm by clinical and radiographic means, which will be confirmed on intra-surgical measurement.
- •A radiographic base of the defect at least 3 mm coronal to the apex of the tooth.
- •Presence of at least 3 mm width of keratinized gingiva around test teeth to allow complete soft tissue coverage of the defect.â€.
排除标准
- •â€œEvidence of localized aggressive periodontitis.
- •Patients with unacceptable oral hygiene (Plaque Index >1) 3)Smokers (recent history of smoking more than 10 cigarettes /day) or who used any of tobacco products.
- •Study tooth with inadequate endodontic / restorative treatments.
- •Study tooth with mobility exceeding grade II and exhibiting a class III or class IV furcation defect.
- •History of periodontal surgical therapy of the selected quadrant.
- •Pregnant females or lactating mothers.â€.
结局指标
主要结局
Radiographic bone fill
时间窗: At six months
次要结局
- Plaque index,Papillary bleeding index,Periodontal pocket depth reduction,Clinical attachment level gain(At six months)