NCT05589025已完成不适用
Pulpotomy Versus Pulpectomy in Carious Vital Pulp Exposure of Primary Incisors: Randomized Controlled Trial
National Research Centre, Egypt0 个研究点目标入组 39 人开始时间: 2015年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- clinical failure
研究概览
简要总结
The aim of this split mouth randomized controlled study was to compare formocresol pulpotomy and zinc-oxide and eugenol pulpectomy in the treatment of vital pulp exposure in primary incisor. 39 Contralateral pairs of incisors were randomly assigned to receive pulpotomy or pulpectomy in children aged from 18 to 66 months old.
Clinical and radiographical evaluations were performed at 6 and 12 months
详细描述
- This randomized controlled trial with split mouth design
- The study was approved by the research ethics committee of the National research centre.
- Participants in this study were recruited from August 2015 till December 2016. Patients' eligibility criteria were medically free patients, aging from 18 to 66 months old, with two or more carious vital primary maxillary incisors where exposure of the vital pulp following the removal of dental caries was inevitable.
- Sample size was calculated using PS Computer Program .A study of matched cases and controls was planned. Prior data indicated that success rates among controls were 0.78 . If the true success rate for experimental subjects is 1, then we needed to study 31 pairs to be able to reject the null hypothesis that the success rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.McNemar's chi-squared statistic was used to evaluate this null hypothesis. This number has been increased to a total sample size 39 in each group, to allow for losses of around 25%.
- The procedure, possible discomforts or risks, as well as possible benefits were explained completely to the parents or legal guardians, and they were allowed to sign in the patients' ethics form.
- The child participants and legal guardian of each participating child were blinded to the type of treatment they received while it was not possible for the operator or the radiographic assessors to be blinded due to the nature of the treatment received.
- An incisor in each pair was randomly assigned by a coin toss to either the intervention (pulpotomy group) on the head side or the control (pulpectomy group) on the tail side with the contralateral paired incisor being designated to the other treatment group.
- Clinical examination and preoperative periapical radiographs were performed for eligible patients. After induction of anesthesia, teeth were properly isolated with cotton rolls and suction as rubber dam was not tolerated by children less than 6 years of age. Complete removal of caries or undermined enamel was performed before access cavity preparation.•
- For follow up: Clinical evaluation was performed on all primary incisors during the follow-up visits at one, six and twelve months post-operatively while radiographic evaluation was performed at six and twelve months follow up visits
- For radiographic evaluation, the radiographs were taken with a size 0 or 1 periapical films (D-speed Film, Ultra-speed Carestream Dental,USA) using the bisecting angle technique. The radiographs were scanned on a viewer and transmitted to a computer hardware to be properly saved. The evaluation was performed by two independent assessors and differences were solved by consensus. Data analysis was performed on the consensus scores.
- For Statistical analysis, Chi square test was used to compare between the two groups. The significance level was set at P ≤ 0.05. Also estimated effect size was calculated with 95% Confidence Interval. Kaplan-Meier used for survival analysis. Statistical analysis was performed with IBM® SPSS® (SPSS Inc., IBM Corporation, NY, USA) .
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)
盲法说明
blinding of assessor of clinical outcomes
入排标准
- 年龄范围
- 18 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two or more carious vital primary maxillary incisors where exposure of the vital pulp following the removal of dental caries was inevitable.
- •No history of spontaneous pain
- •No lingering provoked pain
- •No pain on percussion, No fistula, or sinus tract
- •No history of trauma
- •No periapical radiolucency
- •No pathologic root resorption
- •No pulp calcification.
排除标准
- •Teeth with physiologic resorption exceeding one-third of the root
- •Teeth non-restorable with crowns.
结局指标
主要结局
clinical failure
时间窗: 1 year
composite outcome including pain, soft tissue pathology, and tooth mobility. All are binary outcomes. The presence of any item is recorded as a clinical failure.
radiographic failure
时间窗: 1 year
a composite outcome including pathologic mobility and pathologic root resorption. Both are binry outcomes, the presence of any of them is recorded as a radiographic failure.
次要结局
- survival rate(1 year)
研究者
Lamia Mohamed Khairy Gadallah
Researcher
National Research Centre, Egypt
相似试验
撤回
不适用
Treatment Outcomes of Pulpotomy vs. Pulpectomy in Vital Primary Molars With Symptomatic Irreversible PulpitisIrreversible PulpitisNCT06183203Nebu Philip50
Enrolling By Invitation
不适用
Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible PulpitisPulpitis - IrreversibleNCT05964933National University Hospital, Singapore70
进行中（未招募）
不适用
Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep CariesIndirect Pulp CappingPulpotomyNCT05554952Minia University100
已完成
4 期
BiodentineTM Versus Formocresol Pulpotomy Technique in Primary MolarsPulpotomyDental CariesNCT03779698King Abdulaziz University37
撤回
不适用
Biodentine Partial Pulpotomy of Pulpally Exposed Primary MolarsPulpotomyTooth, DeciduousNCT02393326Hadassah Medical Organization