Comparison of Luxator assisted vs conventional elevator-forceps technique for Root Stump Extraction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Wound Healing
研究概览
简要总结
This study is a randomized controlled trial designed to compare the clinical outcomes of two techniques for tooth root stump extraction: the luxator-assisted technique versus the conventional elevator-forceps method. A total of 150 patients requiring extraction of non-complicated root stumps will be randomly assigned to one of the two groups. The intervention group (Group A) will undergo luxator-assisted extraction, while the control group (Group B) will receive the standard extraction method using elevator and forceps.
The primary outcome will be wound healing, measured using the Landry Wound Healing Index on Day 7 post-extraction. Secondary outcomes will include post-operative pain (measured using the Visual Analog Scale (VAS) on Day 0, 3, and 7), wound diameter (measured with a flexible scale on Day 0 and 7), extraction time (measured with a stopwatch on Day 0), and the impact on quality of life (measured using the OHIP-14 questionnaire on Day 14).
Both participants and outcome assessors will be blinded to the group assignments, ensuring objective evaluation of clinical outcomes. The study aims to determine if the luxator-assisted technique results in superior clinical outcomes in terms of healing, patient comfort, and procedural efficiency compared to the conventional extraction method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient requiring non-complicated tooth root extraction.
- •Patients without active local infection at the extraction site.
排除标准
- •Patients with primary, malformed, dilacerated or third molar roots.
- •Cases requiring trans-alveolar extraction.
- •Patients requiring primary closure after extraction.
- •Patients with uncontrolled systemic comorbidities affecting healing.
- •Patients on anticoagulant therapy.
- •Patients with a history of tobacco/alcohol abuse.
- •Patients with active local infection at the extraction site.
结局指标
主要结局
Wound Healing
时间窗: Day 7
次要结局
- Quality of Life(Day 14)
- Time Taken for Extraction(Day 0)
- Wound Diameter(Day 0, Day 7)
- Post-operative Pain(Day 0, Day 3, Day 7)