The Effect of Different Instrumentation Techniques on the Post-Operative Pain in Pulpectomy Treatment of Primary Molars: A Blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Assessment of post-operative pain after pulpectomy treatment in primary teeth
研究概览
简要总结
The goal of this clinical trial is to compare the post operative pain after using three different instrumentation techniques in pulpectomy treatment of pediatric participant. The main question it aims to answer:
If different instrumentation techniques will affect the post operative pain in pulpectomy treatment of primary molars ? Participants will evaluate the pain using Modified Wong baker pain rating scale.
Researchers will compare [ the adaptive XP endo shaper, Fanta AF baby files, and hand K files] to see if they will affect the post operative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative children free from systemic diseases.
- •Teeth with sufficient coronal tooth structure.
- •Teeth with necrotic pulp.
- •Teeth should have 2/3 of the remaining roots.
排除标准
- •Children taking medications up to six hours before the treatment.
- •Children with multiple teeth that required pulpectomy will not be included to eliminate the possibility of pain referral.
- •Excessive tooth mobility.
- •Teeth with perforated pulpal floor.
- •Teeth with external or internal root resorption.
结局指标
主要结局
Assessment of post-operative pain after pulpectomy treatment in primary teeth
时间窗: one week
Assessment of post-operative pain using Modified Wong-baker pain rating scale. It is 4-point scale measures pain as: * Score zero - no pain. * Score one - slight pain. * Score two - moderate pain. Score three - severe pain. so ( score 0 is the best score \& score 3 is the worst) These data will be recorded at intervals of 6, 12, 24, 72 hours, and one week. A telephonic communication will be done with the parents by the second assessor who will be blinded to the treatment protocol at 6, 12, 72 hours to assess the pain, and the patients will be given two appointments, first after 24 hours and the second after one week from the operating day. During both visits, the second assessor will collect the results of the pain assessment from the child's parent and will cross-check all the results to ensure that the reported values are consistent.
次要结局
未报告次要终点
研究者
Amal Taha
Principal Investigator
Mansoura University