Clinical and radiographic comparative evaluation of indirect pulp treatment with dual cured resin modified calcium silicate ,MTA, and calcium hydroxide in primary molars:A 12 Months follow up randomised clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Dual cured resin modified calcium silicate(TheraCal PT) and MTA show less operating time compared to Calcium Hydroxide
研究概览
简要总结
Children with deep carious lesions and no history of spontaneous pain will undergo standardized periapical and bitewing radiographs. Eligible teeth will be randomly assigned to three groups based on the material used.
During IPT, after topical anesthesia, the tooth will be isolated with a rubber dam. Caries will be removed using a slow-speed handpiece with a round carbide bur. Lateral walls and cavosurface margins will be fully cleaned, while affected dentin at the pulpal floor will be preserved. The cavity will be flushed with saline for 10 seconds and dried with cotton pellets.
For Group I, TheraCal PT will be applied with a syringe, light-cured for 10 seconds, followed by an RMGIC base and composite restoration. In Group II, premixed MTA will be applied with a syringe for 30 seconds, condensed lightly, followed by an RMGIC restoration. In Group III, calcium hydroxide will be mixed in equal parts, applied with ball-ended condensers, followed by an RMGIC restoration.
All cavities will receive RMGIC restoration. A baseline radiograph with a grid will be taken using an XCP holder. Clinical and radiographic evaluations will be performed at 3, 6, and 12 months, assessing pain, percussion tenderness, discoloration, and sinus formation. Radiographs will be scanned and analyzed digitally.
Dentin thickness will be measured using CorelDRAW software. Radiographs will be assessed for root resorption, PDL space widening, periapical radiolucency, dentin formation, and intrapulpal calcifications. Treatment success will require pulp vitality with no spontaneous pain. Radiographic success will require reactionary dentin formation without furcation radiolucency, PDL widening, or root resorption.
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 and Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged 5-10 years History of tolerable dull intermittent pain Mild discomfort associated with eating Negative history of spontaneous extreme pain On clinical examination large carious lesions involving either the occlusal or proximal surfaces with normal appearances of gingiva Radiographic examination revealed carious lesion involving more than 2/3rd thickness of dentin The pulp normal lamina dura normal periodontal ligament space more than 2/3rd of root present no periapical changes no pathologic external or internal resorption should not cause any harm to the succedaneous tooth.
排除标准
- ••History of sharp, penetrating pulpalgia indicating acute pulpal inflammation and necrosis.
- ••Prolonged spontaneous pain at night.
- ••Clinical examination revealed presence of mobility of tooth, discoloration of tooth •Negative reaction to electric pulp testing, sinus opening, or abscessed tooth.
- ••Radiographic examination revealed carious lesion producing 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
Dual cured resin modified calcium silicate(TheraCal PT) and MTA show less operating time compared to Calcium Hydroxide
时间窗: Evaluation will be done at baseline,3 Months,6 Months and 12 Months
次要结局
- Dual cured resin modified calcium silicate(TheraCal PT) & MTA show clinical success as compared to Calcium Hydroxide(Evaluation will be done at baseline,3 Months,6 Months And 12 Months)
研究者
Paresh Pawar
Pacific Dental College and Hospital, Debari Udaipur-313024