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临床试验/CTRI/2023/11/059520
CTRI/2023/11/059520进行中(未招募)3 期

Comparative Evaluation of Post Operative pain, Radiographic and Clinical successes of 1% Sodium hypochlorite and 3% Sodium hypochlorite used as irrigants during Pulpectomy: A Split Mouth Double Blinded Randomized Control Trial

Divya Mukundan1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年11月21日最近更新:

试验速览

阶段
3 期
状态
进行中(未招募)
发起方
入组人数
28
试验地点
1
主要终点
Post operative pain

研究概览

简要总结

In this split-mouth, double-blinded randomized control trial, we aimed to compare the efficacy of two different concentrations of sodium hypochlorite, 1% and 3%, as irrigants during pulpectomy procedures. The study will assess post-operative pain, radiographic success, and clinical outcomes in patients with similar pulp pathologies. Both patients and the observer were blinded to the sodium hypochlorite concentration used on each side of the mouth to minimize bias. Post-operative pain was evaluated using standardized pain scales; radiographic success was determined through pre-operative and post-operative radiographs taken at an interval of 3 months, 6 months, 9 months, and 12 months; and clinical success was assessed through clinical examinations and patient-reported outcomes at an interval of 3 months, 6 months, 9 months, and 12 months. The results of this trial will provide valuable insights into the impact of sodium hypochlorite concentration on the overall success of pulpectomy, aiding pedodontists in making informed decisions regarding the choice of irrigation solution for improved patient outcomes and quality of care.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Healthy patients, Teeth with apical periodontitis after clinical and radiographic confirmation, Presence of 2/3rd of root length and mandibular primary molars.

排除标准

  • Any known history of allergy to any medications; Medically compromised children; tooth with complications such as perforations, fractures and root calcifications, children not under any analgesics or anti-inflammatory drugs for the past 1 week.

结局指标

主要结局

Post operative pain

时间窗: 6 hours, 12 hours, 24 hours

次要结局

  • Radiographic success(clinical success)

研究者

发起方
Divya Mukundan
申办方类型
Other [self]

研究点 (1)

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