A RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFICACY OF AN ALLOPLAST WITH OR WITHOUT “ADVANCED-PRF+” USING MINIMALLY INVASIVE SURGICAL TECHNIQUE IN THE MANAGEMENT OF PERIODONTAL INFRABONY DEFECTS
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ii. Amount of defect fill
研究概览
简要总结
RESEARCH QUESTION
Whether alloplast alone or in combination along with “A-PRF+” using Minimally Invasive Surgical Technique (MIST) is more effective in treatment of periodontal infrabony defects.
AIM AND OBJECTIVES
AIM :- To evaluate the efficacy of alloplast alone or in combination with “A-PRF+” in the treatment of periodontal infrabony defects using minimally invasive surgical technique (MIST).
OBJECTIVES :-
1) To evaluate clinically and radiologically the efficacy of alloplast alone in treatment of periodontal infrabony defects using minimally invasive surgical technique.
2) To evaluate clinically and radiologically the efficacy of alloplast along with “A-PRF+” in treatment of periodontal infrabony defects using minimally invasive surgical technique.
3) To compare clinically and radiologically the efficacy of use of alloplast vs alloplast along with “A-PRF+” in the treatment of periodontal infrabony defects using minimally invasive surgical technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with age more than or equal to 18 with periodontitis.
- •Patients with at least one or more sites with periodontal probing depth (PD) more than or equal to 5 mm when measured using a manual periodontal probe (UNC 15) and CAL more than or equal to 5 mm.
- •Radiographic presence of at least one infrabony osseous defect having depth more than or equal to 3 mm as measured.
- •Patients who will have full-mouth plaque score(FMPS) and full-mouth bleeding score(FMBS) less than or equal to 20 percent
- •Patients who will give consent for participation in the study and shall also be available for all follow periods.
排除标准
- •Patients with any known systemic disease and drug or medication or therapeutic regimen that might interfere with wound healing of soft tissue or bone.
- •Patients who have habit of smoking and or consuming alcohol.
- •Patients allergic to any drug and or material, used in the study.
- •Patients unable or unwilling to undergo surgical procedure.
- •Patients who are pregnant or lactating females.
- •Patients who had undergone periodontal treatment in the previous 6 months.
- •Patients with parafunctional habits such as bruxism.
- •Defect sites with teeth having more than or equal to Grade II furcation involvement.
- •Defect Sites with teeth having mobility more than or equal to Grade III.
- •Defect sites around third molar.
结局指标
主要结局
ii. Amount of defect fill
时间窗: baseline | 12 weeks | 24 weeks
iii. Percentage of defect fill
时间窗: baseline | 12 weeks | 24 weeks
iv. Amount of defect resolution
时间窗: baseline | 12 weeks | 24 weeks
v. Percentage of defect resolution
时间窗: baseline | 12 weeks | 24 weeks
A. Clinical Parameters
时间窗: baseline | 12 weeks | 24 weeks
i. Clinical attachment level (CAL)
时间窗: baseline | 12 weeks | 24 weeks
ii. Pocket depth (PD)
时间窗: baseline | 12 weeks | 24 weeks
B. Radiographic parameters
时间窗: baseline | 12 weeks | 24 weeks
i. Defect depth
时间窗: baseline | 12 weeks | 24 weeks
次要结局
- Clinical Parameters-(i. Plaque index (PI))
研究者
Dr Priyanshi
J.N Kapoor D.A.V Centenary Dental College