跳至主要内容
临床试验/CTRI/2025/12/098793
CTRI/2025/12/098793尚未招募Phase 3 4

comparison of detection rate and ease of locating root canal orifices in primary molars using methylene blue dye versus ophthalmic dye an in vivo study

Nikita Kishor Jakhotiya1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月20日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Detection rate of root canal orifices

研究概览

简要总结

Accurate identification of root canal orifices is a crucial step in performing successful pulpectomy in primary molars, yet it is often challenging due to complex canal morphology, limited visibility, and behavioral constraints in pediatric patients. Diagnostic dyes have been proposed as useful adjuncts to enhance contrast and improve visualization during endodontic access. This randomized in vivo study aims to compare the effectiveness of two commonly used dyes—ophthalmic dye and methylene blue dye—in enhancing the detection of root canal orifices in primary molars of children aged 5–9 years. Eligible teeth requiring pulpectomy will be randomly assigned to either ophthalmic dye (Group I) or methylene blue dye (Group II) following standard access cavity preparation. The primary outcomes include the number of canal orifices successfully located and the operator-reported ease of detection using a standardized scoring scale. Data will be analyzed using appropriate statistical tests such as chi-square and independent t-tests. The study seeks to determine whether ophthalmic dye provides comparable or improved visualization relative to methylene blue. Findings may support the use of these dyes as reliable, safe, and cost-effective adjuncts to improve accuracy and efficiency in pediatric endodontic procedures.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • primary molars requiring pulpectomy Restorable tooth with adequate coronal structure after minimal caries removal to allow isolation and safe access presence of at least twothirds of root length and no advanced physiological root resorption Cooperative behaviour sufficient for treatment in the dental office No known allergy or hypersensitivity to study dyes or any components.

排除标准

  • Teeth with advanced physiological or pathological root resorption Teeth with severe crown destruction Internal or external pathological resorption vertical root fractures or grossly abnormal anatomy on clinical or radiographic exam Presence of a draining sinus tract or extensive acute orofacial swelling Systemic conditions that contraindicate routine dental care Uncooperative behaviour requiring general anaesthesia Known hypersensitivity or allergy to any components of the dyes.

结局指标

主要结局

Detection rate of root canal orifices

时间窗: at baseline

次要结局

  • Ease of locating canal orifices Time taken to locate all canal orifices(at the baseline)

研究者

发起方
Nikita Kishor Jakhotiya
申办方类型
Other [[self]]
责任方
Principal Investigator
主要研究者

Nikita Kishor Jakhotiya

pdch udaipur

研究点 (1)

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