Effectiveness of Autologous Platelet Concentrate for Vital Pulp Therapy in Adult Patients with Carious Pulp Exposure- A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Teeth treated are expected to demonstrate three dimensional dentin bridge formation, which is an indicator of pulp preservation and pulp regeneration
研究概览
简要总结
The aim of this study is to assess pulp sensibility and dentine bridge formation using CBCT imaging following direct pulp capping with PRF (platelet-rich fibrin), PRF combined with Biodentine, and Biodentine in permanent mandibular molars with carious pulp exposure.
Objective: The objective is to assess the effectiveness of an autologous platelet concentrate for direct pulp capping by evaluating the clinical symptomology, pulp sensibility and radiographic three- dimensional dentin bridge formation after one year.
Methodology: This is a prospective, randomized controlled trial. The efficacy of Biodentine, PRF, and PRF with Biodentine will be compared as direct pulp capping agents. The study will involve 30 participants, with 10 in each group, based on a sample size calculation using G Power software.
Inclusion and Exclusion Criteria: Participants aged 18-45 with asymptomatic molars or premolars and carious pulp exposure that meet specific clinical and radiographic criteria will be included. Exclusion criteria encompass symptomatic teeth, systemic diseases, and any factors that may affect healing. Data will be collected through clinical assessments (response to pulp sensibility tests, periodontal evaluations), radiographic analysis, and patient-reported outcomes.
Results: CBCT will be used to analyze the volume of dentine bridges formed by Biodentine, PRF, and PRF with Biodentine as direct pulp capping agents. Responses to pulp sensibility testing will be assessed before the treatment and after the treatment at intervals of 3, 6, 9, and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •30 healthy participants of age group 18 to 45 years Asymptomatic molars with caries exposure Non tender to percussion.
- •Normal response to cold and electric pulp testing.
- •Radiographic evidence of deep caries near the pulp, with no signs of periodontal ligament thickening, furcation radiolucencies, or periapical pathology.
排除标准
- •Symptomatic teeth Radiographic evidence of periapical pathology.
- •Negative response to pulp sensibility testing.
- •History of systemic diseases.
- •Periodontally compromised teeth.
- •Patients with bleeding disorders or platelet count less than 150,000 per cubic mm.
- •Poor oral hygiene maintenance.
- •Pregnant or lactating females.
结局指标
主要结局
Teeth treated are expected to demonstrate three dimensional dentin bridge formation, which is an indicator of pulp preservation and pulp regeneration
时间窗: CBCT analysis will be done before treatment and after 1 year of intervention
次要结局
- teeth treated are expected to respond normally to pulp sensibility testing and should demonstrate normal periapical tissues in radiographic assessment(pulp sensibility and radiographic assessment will be done preoperatively and 3,6,9,12 months after intervention)