A Comparative Evaluation of Conservative and Conventional Access Cavity Preparation in Primary Molars – A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Determining the success/failure of endodontic
研究概览
简要总结
This study is a randomized, parallel-group clinical trial comparing the clinical and radiographic outcomes of endodontic treatment with conventional and conservative access cavities in primary molars among children undergoing pulp therapy. Pediatric patients reporting to the Department of Pediatric and Preventive Dentistry, SRIHER, who meet the inclusion criteria will be recruited. Children who meet the inclusion criteria will be randomly allocated to either of the 2 groups based on the randomization list.
Study group (Group A): Conservative endodontic access cavity restored with resin composite.
Control group (Group B): Conventional endodontic access cavity restored with Type IX glass ionomer cement followed by Stainless steel crown.
The primary outcome of this study will be determining the success/failure of endodontic treatment after 12 months. To be categorized as having overall success, the evaluated tooth must demonstrate both clinical and radiographic success. Clinical and radiographical evaluation will be conducted at intervals of 1, 3, 6, and 12 months. Additionally, the success of the restoration and stainless steel crowns will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 6-10 who require endodontic treatment.
- •Primary molars with occlusal caries and intact marginal ridges (only for conservative access cavity design) -No tooth mobility -Radiographically, caries involving pulp.
排除标准
- •Patients unwilling to participate.
- •Grossly mutilated crown.
- •Root resorption of more than one-third of the root -Children with underlying systemic conditions, special healthcare needs and known haematological/craniofacial disorders -Children allergic to local anaesthetic agents.
结局指标
主要结局
Determining the success/failure of endodontic
时间窗: Clinical and radiographical | evaluation will be conducted at intervals of 1, 3, 6, and 12 months.
treatment after a 12-month period. The success of
时间窗: Clinical and radiographical | evaluation will be conducted at intervals of 1, 3, 6, and 12 months.
the restoration will be assessed for marginal integrity, the presence of secondary caries, and any instances of fractured restoration.
时间窗: Clinical and radiographical | evaluation will be conducted at intervals of 1, 3, 6, and 12 months.
Simultaneously, stainless steel crowns (SSCs) will be evaluated to identify any instances of perforation and crown loss.
时间窗: Clinical and radiographical | evaluation will be conducted at intervals of 1, 3, 6, and 12 months.
次要结局
- Determining the success of restoration and stainless steel crowns(Clinical and radiographical)
研究者
SHALINI B
Department of Pediatric and Preventive Dentistry