Evaluation of the increase in dentinal barrier thickness formed by indirect pulp treatment with two different indirect pulp capping agents in primary molars- a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To compare the increase in dentinal barrier thickness formed by two types of Indirect pulp capping agents used in the treatment of carious lesions in primary molars over a period of 12 months.
研究概览
简要总结
Primary molars to be selected from patients aged 5 to 8 years attending the OP of the Department of Pediatric and Preventive dentistry in Amrita school of dentistry. Primary teeth with carious lesion approaching the pulp and indicated for indirect pulp capping will be chosen. Local anesthesia will be administered following which rubber dam application will be done. Caries excavated and Indirect pulp treatment will be done with: Group 1: SafeEndo BioStructure MTA and Group 2: Light curing Calcium hydroxide (VOCO Calcimol LC). Resin modified GIC base (RMGIC) given subsequently and Composite restoration will be placed on top of base material after etching and bonding. Baseline radiograph will be taken on the same day. Patient will be recalled for review at 3 months, 6 months and 12 months. Tooth will be clinically examined and radiographically evaluated. Radiographs will be taken at 3 months, 6 months and 12 months and subsequently scanned and transferred to the computer for digital analysis. The increase in dentin thickness measured using Corel Draw software, Version 13
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary molars meeting the following criteria will be included in the study: On clinical examination, large carious lesions involving either occlusal or proximal surfaces, with normal appearances of the gingiva will be identified.
- •Participants with a history of tolerable dull intermittent pain and mild discomfort associated with eating will be included.
- •On radiographic evaluation, primary molars with carious lesions involving more than 2/3rd thickness of dentin approximating the pulp, normal lamina dura and periodontal ligament space, and more than 2/3rd of the root present without periapical changes will be included.
排除标准
- •Primary molars with the following criteria will be excluded from the trial: Having history of sharp, penetrating pulpalgia indicating acute pulp inflammation and necrosis, prolonged pain at night.
- •On Clinical examination, presence of mobility of tooth, discoloration of tooth, negative reaction to electric pulp testing, sinus opening or abscessed tooth.
- •On radiographic evaluation, carious lesion with definite pulp exposure, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency, internal or external resorption.
结局指标
主要结局
To compare the increase in dentinal barrier thickness formed by two types of Indirect pulp capping agents used in the treatment of carious lesions in primary molars over a period of 12 months.
时间窗: 3,6,12 months
次要结局
- follow up(3,6,12 months)
研究者
Janaki Shaji
Amrita School of Dentistry