Comparative evaluation of selective caries removal to firm dentin, selective caries removal to soft dentin with 5% sodium hypochlorite lavage, and selective caries removal to soft dentin with Biodentine liner placement: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Maintenance of pulp vitality (positive response to cold test, absence of spontaneous pain, absence of tenderness on percussion, absence of swelling/abscess/fistula).
研究概览
简要总结
Dental caries remains the most prevalent oral disease, with deep carious lesions posing a significant risk of pulpal exposure and loss of vitality. Contemporary minimally invasive strategies advocate selective caries removal to preserve pulp health while minimizing operative trauma.
This randomized controlled clinical trial will evaluate and compare the success of three treatment protocols in permanent teeth of children aged 6–15 years with deep carious lesions (ICDAS 5–6):
- Selective caries removal to firm dentin (SRFD) followed by Biodentine liner placement (control group).
- Selective caries removal to soft dentin (SRSD) followed by 5% sodium hypochlorite lavage.
- Selective caries removal to soft dentin (SRSD) followed by Biodentine liner placement.
Seventy-five participants will be randomly allocated into three parallel groups (25 per group) using simple randomization with allocation concealment by opaque envelopes. Double blinding (patient and evaluator) will be maintained. Clinical and radiographic assessments, including pulp vitality, pain scoring (VAS), and absence of periapical pathology, will be performed at immediate, 3, 6, 9, and 12 months post-treatment.
The primary outcome is maintenance of pulp vitality with absence of clinical/radiographic signs of pathology. Secondary outcomes include comparative success rates between groups and restoration survival. This study aims to provide evidence on the efficacy of sodium hypochlorite lavage and Biodentine in vital pulp preservation in deep carious lesions.
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
- 6.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 6–15 years of either gender, in good general health.
- •At least one permanent posterior tooth with deep carious lesion extending into ¾ of dentin, confirmed radiographically (ICDAS score 5–6).
- •Asymptomatic teeth on clinical evaluation (no spontaneous pain).
- •Parents/guardians providing written informed consent.
排除标准
- •Negative response to cold test (–50 °C Endo-Frost spray).
- •Presence of spontaneous pain, pain on palpation/percussion, abscess, fistula, or swelling.
- •Non-carious lesions (attrition, abrasion, erosion, or abfraction).
- •Radiographic signs of periapical pathology (loss of lamina dura, periodontal ligament space widening, root canal obliteration, internal or external resorption).
- •Children with systemic illness or in poor general health.
- •Subjects unwilling to participate or whose parents do not provide consent.
结局指标
主要结局
Maintenance of pulp vitality (positive response to cold test, absence of spontaneous pain, absence of tenderness on percussion, absence of swelling/abscess/fistula).
时间窗: Immediate post-operative, 3 months, 6 months, 9 months, and 12 months.
Absence of radiographic signs of pathology (no periapical radiolucency, no widening of periodontal ligament space, no root resorption, no canal obliteration).
时间窗: Immediate post-operative, 3 months, 6 months, 9 months, and 12 months.
Pain assessment using Visual Analog Scale (VAS, 1–10).
时间窗: Immediate post-operative, 3 months, 6 months, 9 months, and 12 months.
次要结局
- Comparative success rate between selective caries removal to soft dentin followed by 5% sodium hypochlorite lavage and selective caries removal to soft dentin followed by Biodentine liner.
研究者
Deepika Singh
Pt B D Sharma Post Graduate Institute of Dental Sciences