Efficacy of conventional flap surgery, Non-Incised Papilla Surgical Approach (NIPSA) and Modified Minimally Invasive Surgical Technique (M-MIST) in the management of intraosseous defects in stage III periodontitis- A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
This study is a randomized, single blind, parallel group clinical trial evaluating the efficacy of three surgical techniques—Conventional Flap Surgery, Non-Incised Papilla Surgical Approach (NIPSA), and Modified Minimally Invasive Surgical Technique (M-MIST)—in the management of intraosseous defects in 33 patients with Stage III periodontitis. The study will be conducted at the Government Dental College, Thiruvananthapuram, over a period of 15 months. Platelet-rich fibrin (PRF) will be used in all groups as an adjunct to enhance healing. The primary outcome measure is probing depth upto four months. Secondary outcomes include clinical attachment level, soft tissue preservation, radiographic bone fill, bleeding on probing, plaque index, and patient satisfaction assessed at various intervals up to four months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of age above 20 years with good oral hygiene.
- •2.Patients who have given written informed consent and are willing to participate in the study.
排除标准
- •1.Patients suffering from systemic illness (Diabetes, Hypertension, cardiovascular disorders, patients under steroids/drugs affecting bone metabolism and bleeding or clotting disorders).
- •3.Presence of an orthodontic appliance.
- •4.Pregnancy or breast feeding.
结局指标
主要结局
Probing depth
时间窗: Baseline, 6 weeks and 4 months
次要结局
- Clinical attachment level (CAL).(Baseline, 6 weeks and 4 months)
- Soft tissue preservation based on Gingival recession (GR) and Location of the Tip of the papillae (TP).(Baseline,6 weeks and 4 months)
- Bleeding on probing (BOP).
- Plaque index (Silness and Loe index).
- Radiographic bone fill.
- Patient satisfaction(6 weeks)