Comparative evaluation of the treatment outcome of entire papilla preservation technique and modified-minimally invasive surgical technique in intrabony defect: a double blinded randomised controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To clinically evaluate and compare the use of the entire papilla preservation technique and the modified-minimally invasive surgical technique in the management of intrabony osseous defects.
研究概览
简要总结
THE AIM OF THIS RANDOMIZED CLINICALTRIAL (RCT) IS TO EVALUATE THE CLINICAL AND RADIOGRAPHIC EFFECTIVENESS OFENTIRE PAPILLA PRESERVATION SURGICAL TECHNIQUE (EPP) TO MODIFIED MINIMALLYINVASIVE SURGICAL TECHNIQUE (M-MIST) IN THE TREATMENT OF PERIODONTAL INTRAOSSEOUSDEFECTS IN STAGE III PERIODONTITIS PATIENTS METHODOLOGY OF THIS STUDY IS TOTALNUMBER OF THIRTY PATIENTS (30–60) YEARS OLD SUFFERING FROM STAGE IIIPERIODONTITIS WERE RECRUITED, ASSIGNED AND ALLOCATED RANDOMLY TO ONE OF TWOGROUPS, GROUP A (INTERVENTION GROUP) TO RECEIVE ENTIRE PAPILLA PRESERVATIONTECHNIQUE (EPP) AND GROUP B (CONTROL GROUP) TO RECEIVE MODIFIED MINIMALLYINVASIVE SURGICAL TECHNIQUE (M-MIST). EACH PATIENT PRESENTED INTRA-BONYDEFECTS: THE SELECTED SITES WERE DIVIDED RANDOMLY INTO TWO TREATMENT GROUPS.CLINICAL ATTACHMENT LEVEL GAIN (CAL GAIN) WAS RECORDED AS PRIMARY OUTCOME ANDRECALL APPOINTMENTS WERE CARRIED OUT AT 3 AND 6-MONTHS POST OPERATIVELY.RADIOGRAPHICAL PARAMETERS WERE EVALUATED PRESURGICALLY AND AFTER 3 AND 6MONTHS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of two or more intra-bony defects, average probing pocket depth (PPD) Between 5-8mm, average clinical attachment level (CAL) between 5-10mm, radiographic depth≥4mm.
排除标准
- •Defects involving lingual sites, patients with a history of systemic conditions that affect the periodontium, smokers.
结局指标
主要结局
To clinically evaluate and compare the use of the entire papilla preservation technique and the modified-minimally invasive surgical technique in the management of intrabony osseous defects.
时间窗: Baseline,3 Months,6 Months
次要结局
- To radiographically evaluate & compare the use of the entire papilla preservation technique & modified minimally invasive surgical technique in the management of intrabony osseous defects.(Baseline,3 Months,6 Months)