Clinical Success of Indirect Pulp Capping Using Biodentine, Theracal PT and Therabase in Primary Molars: 1-Year Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- successful completion of research
研究概览
简要总结
The goal of this clinical trial is to compare the clinical success of theracal pt, therabase, and biodentine indirect pulp capping on primary molars with deep dentin caries. Indirect pulp capping was used on the primary molars of the participants with deep dentin caries. It is aimed to compare the success of biodentine, which is considered the gold standard used in capping treatments, and the currently marketed Teracal PT and Therabase materials after 1, 6 months and 1 year, with biodentine and with each other, and find out which material is more successful.
详细描述
This study utilized a parallel group, randomized controlled design and enrolled patients who visited the Department of Pediatric Dentistry, Health Sciences University, İstanbul, Turkey, in the period of 2020-2022. The study protocol was approved by the Health Sciences University Hamidiye Clinical Research Ethics Committee (7/34).
All procedures were conducted in accordance with the ethical standards of the relevant national and institutional committees on human experimentation with the Helsinki Declaration of 1975, as revised in 2013. The parents or legal guardians provided written in formed consent.
The sample size was calculated using a G*Power program (G*power 3.1 version) for the distribution of the success rates in the Biodentine, Therabase and TheraCal PT groups regarding the follow-up periods, the following parameters were used: medium effect size f 0.34, error = 0.05, minimum 80% power. Based on these parameters, the total sample size was calculated as 28 participants for each group.
This study was conducted as a prospective clinical and radiographic evaluation. A total of 76 teeth (first and second primary molars) from 5- to 9-year-old healthy and cooperative children with nonclinical and radiographic evidence of infection symptoms and with indications for indirect pulp treatment were included in this study. The teeth were divided into three groups according to the pulp capping materials.
Inclusion and exclusion criteria:
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
patients and the researcher who evaluates the follow-up results of the patients will not know which material was used for indirect pulp coating.
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 5-9 years
- •Previously untreated first and second primary molars with deep caries
- •First and second primary molar teeth with positive pulpal response in vitality tests
- •Primary molar teeth with radiographically detected caries involving approximately ¾ of the dentin thickness
- •Primary molar teeth with the potential for pulp exposure according to the procedure in which the carious tissue is completely removed
排除标准
- •Teeth showing signs of irreversible pulpitis (spontaneous pain, no prolonged pain response)
- •Teeth with symptoms of pain on percussion or palpation
- •Teeth with pathological mobility
- •Teeth with infectious symptoms such as fistula or abscess
- •Teeth showing discoloration on clinical examination
- •Radiolucency observed in the periapical region or furcation on radiographic examination
研究组 & 干预措施
theracal pt
Teeth treated with indirect pulp capping with theracal pt
干预措施: indirect pulp capping with theracal pt (Procedure)
therabase
Teeth treated with indirect pulp capping with therabase
干预措施: indirect pulp capping with therabase (Procedure)
biodentine
Teeth treated with indirect pulp capping with biodentine
干预措施: indirect pulp capping with biodentine (Procedure)
结局指标
主要结局
successful completion of research
时间窗: 1 year
Completion of 1-year follow-up of patients. The patients were called for follow-up at 1 months, 6 months and 1 year during the first year. At each follow-up visit, a clinical examination was performed to assess the presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. Additionally, a radiographic examination was performed to assess the presence of lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The teeth detected with none of these findings at any time considered successful.
unseccessful completion of research
时间窗: 1 year
The patients were called for follow-up at 1 months, 6 months and 1 year during the first year. At each follow-up visit, a clinical examination was performed to assess the presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. Additionally, a radiographic examination was performed to assess the presence of lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The teeth detected with at least one of these findings were considered 'unsuccessful.'
次要结局
未报告次要终点