EFFICACY OF OPEN FLAP DEBRIDEMENT WITH 0.8% HYALURONIC ACID IN TREATMENT OF INTRABONY DEFECTS: A CLINICAL TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. Probing pocket depth
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the efficacy of open flap debridement (OFD) with 0.8% hyaluronic acid (HA) in the treatment of periodontal intrabony defects. Thirty-two sites in patients with chronic periodontitis will be randomly assigned into two groups: Group A (OFD alone) and Group B (OFD with 0.8% HA). Clinical parameters like probing pocket depth (PPD), clinical attachment level (CAL), and early healing index (EHI), along with radiographic evaluation of bone fill and crestal bone level using cone-beam computed tomography (CBCT), will be recorded at baseline, 3 months, and 6 months. The study aims to determine whether adjunctive HA offers additional regenerative benefits over OFD alone.
Hyaluronic acid is a biocompatible, biodegradable glycosaminoglycan with proven wound healing, anti-inflammatory, and osteogenic properties. It has shown promising outcomes in periodontal regeneration by promoting soft tissue healing, enhancing angiogenesis, and facilitating bone regeneration. However, based on previous literature, this study expects superior clinical and radiographic outcomes in the HA group. This trial will help establish the adjunctive role of HA in regenerative periodontal surgery and may offer a minimally invasive, biomimetic approach for the management of periodontal intrabony defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Probing pocket depth greater than or equal to 5 mm.
- •Clinical attachment loss greater than or equal to 3 mm.
- •Sites exhibiting evidence of intrabony defects of minimum 3 mm dimension as observed through Cone beam computed tomography (CBCT).
排除标准
- •Subjects who went through periodontal therapy within the previous year.
- •Subjects taking any medication which can influence the gingival response during healing.
- •Subject with any systemic disease affecting periodontium.
- •Pregnant women and lactating mothers.
- •Subjects with blood dyscrasia or bleeding disorder.
- •Smokers and tobacco chewers.
- •Subjects who cannot perform routine oral hygiene procedures or do not comply with oral hygiene instructions.
结局指标
主要结局
1. Probing pocket depth
时间窗: 1. Probing pocket depth at baseline, 3 months, 6 months | 2. Clinical attachment level at baseline, 3 months, 6 months | 3. Early healing index after 7 days
2. Clinical attachment level
时间窗: 1. Probing pocket depth at baseline, 3 months, 6 months | 2. Clinical attachment level at baseline, 3 months, 6 months | 3. Early healing index after 7 days
3. Early healing index
时间窗: 1. Probing pocket depth at baseline, 3 months, 6 months | 2. Clinical attachment level at baseline, 3 months, 6 months | 3. Early healing index after 7 days
次要结局
- 1. Intrabony defect bone fill and the crestal level of bone, using Cone beam computed tomography (CBCT).(To compare results obtained in test and control groups.)
研究者
Dr Narayani Singh
Department of Periodontology