跳至主要内容
临床试验/NCT04587089
NCT04587089尚未招募1 期

Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth - Study Protocol for a Randomized Controlled Clinical Trial

University of Nove de Julho0 个研究点目标入组 120 人开始时间: 2023年8月20日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
入组人数
120
主要终点
Clinical Investigation of Changes in Tooth Mobility in Each Treated Tooth

研究概览

简要总结

The maintenance of the deciduous tooth until its physiological exfoliation occurs is one of the main objectives of pediatric dentistry. Endodontic treatment in deciduous teeth resulting from carious or traumatic lesions with pulpal involvement is often necessary and we often find it difficult to perform it, due to the difficult control of the child, the internal anatomy of the root canals, and root resorptions. The non-instrumental endodontic treatment technique (TENI) associated with antimicrobial drugs has advantages such as shorter chair time and less complexity than the conventional technique in which root canal instrumentation is performed. The objective of this study is to carry out a controlled and randomized clinical trial to compare the effectiveness of non-instrumental endodontic treatment (NIET) in primary teeth associated with the use of two filling pastes. 120 necrotic deciduous teeth of children aged between 3 and 6 years will be selected; and the teeth will be divided into two groups. In Group 1 and Group 2, the root canals will not be instrumented, just irrigated and filled with the respective pastes, CTZ and Guedes-Pinto. The radiographic aspects will be evaluated, considering the repair process, clinically will be evaluated: presence of fistula and mobility, the evaluations will be carried out in both groups on the day of treatment and in periods of 1, 3 and 6 months after treatment. The data obtained will be submitted to the Shapiro-Wilk normality test, where the statistical analysis that will be used for this study will be defined, adopting a significance level of 95% (p<0.05).

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
Single (Outcomes Assessor)

盲法说明

The clinical, radiographic and microbiological evaluations will be made by an assessor who will not know to which group the participants belong.

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged 3 to 6 years old with at least one anterior deciduous tooth with pulp necrosis in a position to be restored and at least 2/3 of the remaining root.
  • Healthy patients and who did not antibiotic treatment in the previous three months.

排除标准

  • Compromised health, primary teeth with more than one third root loss, lack of internal pathological resorption, impossibility of restoration, cases of re-treatment and crypt involvement.

结局指标

主要结局

Clinical Investigation of Changes in Tooth Mobility in Each Treated Tooth

时间窗: Baseline, one month, 3 months and 6 months after treatment.

In the follow-up consultations, teeth will be clinically evaluated to check the presence of mobility.

Clinical Investigation of the Change in the Presence of Fistulas in Each Treated Tooth

时间窗: Baseline, one month, 3 months and 6 months after treatment.

In the follow-up consultations, teeth and gums will be clinically evaluated to check the presence of fistulas.

次要结局

  • Radiographic Evaluation of the Changes in the Presence of Periapical Lesions in Each Treated Tooth(One month, 3 months and 6 months after treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Kalil Bussadori

Principal Investigator

University of Nove de Julho

相似试验