Assessment of the Efficacy of Apical Barrier Technique in Preventing the Extrusion of Obturating Material Using Resorbable Collagen Plug and Modified Suture Apical Matrix in Primary Mandibular Molar Undergoing Resorption-A Randomised Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- 1.APICAL EXTRUSION:Efficacy of different apical barriers in preventing apical extrusion of obturating materials in deciduous tooth pulpectomies
研究概览
简要总结
Assessment of the efficacy of apical barrier technique in preventing the extrusion of obturating material using resorbable collagen plug and modified suture apical matrix in primary mandibular molar undergoing resorption- A randomized controlled trial.
Pulp therapy in primary teeth, particularly in resorbing mandibular molars, is often complicated by apical extrusion of obturating material due to open apices and physiological root resorption. Extrusion may result in postoperative complications such as inflammation, pain, or damage to the underlying permanent tooth bud.
Effective apical barriers are needed to prevent this while maintaining biocompatibility and resorbability suitable for primary dentition.This study assess the efficacy of different resorbable apical barriers in preventing apical extrusion of obturation materials in deciduous tooth pulpectomies.
The groups are Group A: Resorbable collagen plug as apical barrier. Group B: Modified suture apical matrix as apical barrier. Group C (Control): Conventional obturation without apical barrier.
Sample size of the study is 225 root canals and the study period is 1.5 years.
Primary objective is to compare the radiographic assessment of apical extrusion of obturating material using three different techniques.
Secondary objective is to compare the radiographic success of obturation using these three techniques immediately and 6 month interval. To assess the clinical success of obturation using these three techniques 3month and 6 month interval. To compare the time taken for obturation using these three technique.
The null hypothesis state that there is no significant difference in the apical extrusion of obturating material in resorbing primary mandibular molars with apical barrier technique using resorbable collagen plug or modified suture apical matrix and the conventional method of obturation without the use of an apical barrier.
The following clinical outcomes are assessed-
Presence of apical extrusion of obturation material , Quality of obturation (radiographic), radiographic success immediately and 6 months after obturation, Clinical success of obturation in 3 and 6 months and finally Time taken for obturation using stopwatch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.7-10 year old children whose mandibular primary molar with irreversible pulpitis indicated for pulpectomy.
- •2.Primary mandibular molars with at least two-thirds of the root length reamaining.
- •3.Patients exhibiting Frankels positive or definitely positive behavior.
排除标准
- •1.Non-restorable teeth.
- •2.Radiographic evidence of severe external or internal pathological resorption.
- •3.Peri-radicular radiolucencies involving the permanent tooth follicle.
- •4.Primary mandibular molars with preoperative radiographs showing extreme positioning (mesial/distal) of the permanent tooth bud.
- •5.Teeth with no radiographic resorption.
- •6.Dentition with congenitally missing permanent tooth buds.
- •7.Uncooperative during treatment after initially being cooperative.
- •8.Tooth with perforation of the pulpal floor.
- •9.Extreme tooth mobility.
- •10.Presence of dentigerous or follicular cyst.
- •11.Differently abled children and childrens with systemic disease.
结局指标
主要结局
1.APICAL EXTRUSION:Efficacy of different apical barriers in preventing apical extrusion of obturating materials in deciduous tooth pulpectomies
时间窗: 1.Apical extrusion assessed using radiograph immediately after obturation.
次要结局
- 1.Radiographic Success(2.Clinical Success)
研究者
Risana Jasmin V P
Government Dental College ,Kozhikode