Comparative evaluation of clinical and radiological parameters following the use of biphasic alloplastic material with Amniotic membrane / Collagen membrane for the management of periodontal intra-bony defects - A prospective double blind randomized controlled clinical trial.

nivedhav1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2020年3月22日最近更新: 2020年3月17日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 40
试验地点: 1
主要终点: Change in Probing Pocket Depth or Clinical Attachment Level and Radiographic bone gain

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a prospective double blind, randomised, parallel group clinical trial comparing the clinical and radiological parameters following the use of biphasic alloplastic material with amniotic membrane/ collagen membrane for the management of periodontal intrabony defects. The primary outcomes will be to assess the change in probing pocket depth/ clinical attachment level and radiographic bone gain at 1, 3 and 6 months, secondary outcomes will be assess the wound healing index, visual analogue scale at 3 and 10 days post operatively.

研究设计

研究类型: Interventional
分配方式: Stratified block randomization
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 21.00 Year(s) 至 50.00 Year(s)（—）
性别: All

入选标准

•1 Age 21-50 years 2 Patients with moderate to severe localized periodontitis with a Probing Depth (PD) â‰¥6 mm and an intrabony component of more than 3 mm as detected on Intra oral periapical radiographs (IOPAR) and bone sounding (Sali 2016).
•3 Intrabony defect angle of less than 40 degree (Sali 2016).
•4 Circumferential defect with interdental intrabony defect depth of more than 3mm will be included.
•5 Nonsmoker (Never smoker) or former smoker (Does not smoke now and has not smoked at all for a minimum of the last 12 consecutive months).

排除标准

•1 Current Smokers (smokers who have smoked more than 100 cigarettes in their lifetime and currently smoke) 2 Systemic chronic conditions known to be associated with periodontitis or with changes in systemic inflammation: Diabetes, Cardiovascular diseases, Rheumatoid Arthritis, Rheumatic Fever, SLE, Malignancy, Respiratory diseases, Renal diseases, Other (e.g., autoimmune diseases, fungal infections, immunological deficiencies, etc.) 3 Pregnant / Lactating mothers 4 Previous History of periodontal treatment at the selected site 5 Teeth with intrabony defect component and furcation involvement were also excluded from the study.

结局指标

主要结局

Change in Probing Pocket Depth or Clinical Attachment Level and Radiographic bone gain

时间窗: baseline, 1 month, 3 month and 6 month

次要结局

Wound Healing index, Visual Analogue Scale(at 3, 10 days)

研究者

发起方

nivedhav

申办方类型

Other [self sponsor ]

研究点 (1)

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