Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic: Randomized Non-inferiority Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Success or failure of treatment
研究概览
简要总结
The pulp therapy in primary teeth is still necessary even with all odontopediatrics evolution in prevention and minimal intervention, aiming to keep the tooth free of inflammation or infection and in a functional state until its exfoliation. Several materials are used as filling paste of primary teeth. In Brazil, the Guedes-Pinto Paste (PGP), an association of iodofórmio, camphorated paramonochlorophenol, prednisolone and rifamycin, has been widely used for some decades. However, current Brazilian legislation has made it difficult to commercialize antibiotics, which has made it difficult to obtain the ointment that is the association between prednisolone and rifamycin. Therefore, the objective of this clinical trial will be to test PGP without rifamycin in the pulpectomy of primary teeth, and to compare it with the treatment performed with conventional PGP.
详细描述
A randomized triple-blind non-inferiority clinical study with two parallel arms, with a 12-month follow-up, will be performed. The experimental group will be PGP formulated without the antibiotic, while the control group is the conventional PGP, containing rifamycin. The conventional pulpectomy will be performed using manual files, performing the instrumentation aided by Endo-PTC and 1% sodium hypochlorite. At the end of the instrumentation, just before the obturation, the groups will be drawn, with the strategy of randomization in permuted blocks and stratified by the initial condition of the tooth (with or without periapical lesion). The main outcome will be the clinical and radiographic success of endodontic treatment after 12 months.Patients who seek the dental service of the municipality and require endodontic treatment will be invited to participate in the study. The data will be statistically analyzed using the statistical package Stata 12.0 (Stata Corporation, College Station, TX, USA). The longevity of the treatments will be evaluated by estimating survival rates using the Kaplan-Meier method. The differences between survival rates according to the type of endodontic treatment proposed will be analyzed through the Log-rank test.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Both materials will be packed in identical and opaque syringes, identified only with letters (A and B). The codes will be revealed only at the end of the study. Neither the professional who will be performing the treatment, nor the patient or the evaluator, who will perform the exams at follow-up times, will know which of the two materials of choice were selected for each tooth, characterizing the study as triple-blind.
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary molar teeth with necessity of endodontic treatment.
- •Patients whose parents or guardians consent to their participation in the study
排除标准
- •Systemic health problems, congenital facial deformities, facial tumors or syndromes
- •Teeth presenting one of the following:
- •Resorption of more than 2/3 of the root
- •Destruction of the crypt of the permanent successor
- •Pulp chamber floor drilling.
- •Presence of internal resorption
研究组 & 干预措施
Pasta Guedes-Pinto
Endodontic treatment using Guedes-Pinto Paste
干预措施: Endodontic treatment using Guedes-Pinto Paste (Drug)
Pasta Guedes-Pinto without antibiotic
Endodontic using Guedes-Pinto paste without antibiotic
干预措施: Endodontic using Guedes-Pinto Paste without antibiotic (Drug)
结局指标
主要结局
Success or failure of treatment
时间窗: 1 year
The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: no occurrence of a periapical rarefaction in the furcation area; reduction or maintenance of an already present bone rarefaction in the furcation area of posterior teeth, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions, we will compare the initial and final radiographs. Despite the anticipated time frame of 1 year, some participants were evaluated after this period due to the pandemic. The follow-up periods were until 24 months, and the final analysis were adjusted for this protocol deviation.
次要结局
- Post-operative fistula(7 days)
- Post-operative pain(7 days)
- Post-operatve oedema(7 days)
- Quality of root canal filling(Imediatelly after the treatment)
研究者
Fausto Medeiros Mendes
Principal investigator
University of Sao Paulo