Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- visual examination
研究概览
简要总结
The objective of the study is to evaluate the success rate of pulpotomies in temporary molars using different types of hemostats and pulp coating materials based on tricalcium silicates, in patients who have attended the Dental Clinic of the International University of Catalonia (UIC).
详细描述
This prospective randomized clinical trial study has been approved by the
Scientific Committee in January of 2017 and by Ethics Committee (END-ECL- 2017-01) . It will be conducted in patients needing a vital pulp
therapy treatment at the Pediatric Dentistry Department of Universitat Internacional de Catalunya (Sant Cugat del Vallés, Barcelona, Spain). The necessary statistical sample size assuming an alpha risk of 0.05, a beta risk of 0.05 and a power of 95% sample, the required sample obtained by group resulted in 52. Given an estimate upwards of 20% of drop-outs in controls, the final size results in 62.4 (63 cases per group).
The data collection will be recollected using Excel program. Statgraphics Centurion XV software (StatPoint Technologies, Inc., Warrenton, VA, USA) will be used for statistical analysis. The chi-square test will be used and logistic regression analysis of the results will be performed to assess differences between groups with a significance level of 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
- 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
- •Responsible patients or parents or guardians who demonstrate that they understand the study and are willing to participate, as evidenced by signing the voluntary informed consent and receiving a signed and dated copy of the informed consent form.
- •Children under 18 years of age with informed parental consent, correctly understood.
- •Patient understands and is willing to comply with all study procedures and restrictions.
- •Absence of clinical and radiographic evidence of pulp degeneration such as excessive bleeding, internal and / or external root resorption, destruction of the furcation.
- •Asymptomatic and vital primary molars whose pulp exposure occurred during caries removal.
排除标准
- •Patients with systemic pathologies (diabetes, inmunosuppresed or any clinically significant or relevant oral abnormality).
- •Previous history of allergic reaction to local anesthesics or to the different constituents of the pulp agents to be studied.
- •Pulp diagnosis of irreversible pulpits or pulp necrosis, root resorption, root fractures, pathological mobility, spontaneous pain, impossibility of restoration, and if pulpotomy is not the treatment of choice.
结局指标
主要结局
visual examination
时间窗: 12 months
Clinical examination.Data will be recorded in terms of clinical signs of success.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination.
Radiographic Success
时间窗: 12 months
RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis or pathology root resorption.
次要结局
- External Resorption(12 months)
- Fistulation(12 months)
- Internal Resorption(12 months)
- Furcation Radiolucency(12 months)
- Swelling(12 months)
- Radicular Radiolucency(12 months)
- Symptoms of pain(12 months)
- Pathological Mobility(12 months)
研究者
Francisco Guinot-Jimeno
Head of the pediatric dentistry department.
Universitat Internacional de Catalunya