Clinical and Radiographic Evaluation Of Three Different Indirect Pulp capping Materials in Primary Molars: A Randomized Clinical study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Preservation of pulp vitality assessed through clinical and radiographic evaluations (absence of symptoms such as pain, swelling, or signs of infection, and no radiographic evidence of periapical pathology or internal resorption
研究概览
简要总结
Various materials have been used for indirect pulp capping, with calcium hydroxide as the gold standard. However, its limitations have led to the exploration of alternatives like EndoSequence root repair material (ERRM) and ACTIVA BioACTIVE, which aim to promote pulp healing while addressing the drawbacks of calcium hydroxide. ERRM is a calcium silicate-based cement, while ACTIVA BioACTIVE combines the properties of resin-modified glass ionomer cement (RMGIC) with a modified resin matrix. These materials release beneficial ions for pulp health.
AIM and OBJECTIVES:
Aim:
To evaluate and compare the clinical and radiographic success of indirect pulp capping with three different materials (Calcium hydroxide, EndoSequence Root repair material and ACTIVA bioACTIVE at 3, 6, 9 and 12 month interval.
Objectives:
1. To evaluate the clinical and radiographic success of indirect pulp capping agents (Calcium hydroxide, EndoSequence root repair material and ACTIVA BioACTIVE.
2. To assess the effectiveness of EndoSequence root repair material and ACTIVA BioACTIVE when compared with Calcium hydroxide (Dycal).
MATERIAL AND METHODS:
Study Setting:
The study will be conducted at the Post-Graduate Clinic, Department of Paediatric and Preventive Dentistry, King George’s Medical University, Lucknow, Uttar Pradesh.
Study Design:
This is a randomized controlled clinical trial conducted at the same department.
Participants:
Children aged 4-9 years will be screened. Inclusion criteria focus on cooperative patients with dental issues, while exclusion criteria involve medical complications and uncooperative behavior.
Randomization and Blinding:
Participants will be divided into three groups using random numbers. Allocation will be concealed. A single operator will perform the procedures, and an independent observer will handle follow-up, ensuring blinding.
Procedure:
Informed consent will be obtained from parents, carious lesions will be treated with one of three materials, and follow-up evaluations will occur at 3, 6, 9, and 12 months.
Sample Size:
A total of 81 participants (27 per group) was calculated to be sufficient for statistical analysis.
Statistical Analysis:
Data will be analyzed using SPSS version 21. Categorical outcome measures will be compared using chi-square tests, with significance set at p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Cooperative patients with FRANKL rating 3 and
- •2.Restorable first or second primary molar (maxillary or mandibular molar) with deep occlusal carious lesions involving approximately 3/4th of the dentin.
- •3.Teeth with signs of reversible pulpitis 4.No history of spontaneous pain, tenderness to percussion, abscess or fistula.
- •5.Absence of clinical and radiographical pulp involvement 6.Extension of caries such that it has potential to expose the pulp if removed completely 7.Teeth with the absence of pathological root resorption or periapical or furcal radiolucency 8.Teeth with less than one-third physiological root resorption.
排除标准
- •1.Medically compromised patients 2.Uncooperative patients with FRANKL scale less than 3 3.Teeth with history of night pain, abscess, swelling and tenderness.
- •4.Teeth with clinical or radiographic involvement of pulp 5.Teeth with periapical or furcal radiolucency 6.Patients who decline to participate.
结局指标
主要结局
Preservation of pulp vitality assessed through clinical and radiographic evaluations (absence of symptoms such as pain, swelling, or signs of infection, and no radiographic evidence of periapical pathology or internal resorption
时间窗: 3, 6, 9, 12 months
post operative pain (VAS)
时间窗: 3, 6, 9, 12 months
次要结局
- Restorative material integrity (USPHS criteria)
研究者
Bhawana Kumari
KING GEORGES MEDICAL UNIVERSITY