In Vitro Comparison of Leakage in Endodontically Treated Teeth Obturated With Different Types of GP Coatings Using Bioceramic Sealer: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- post obturation leakage
研究概览
简要总结
In vitro study to compare the sealing ability of bioceramic-coated gutta-percha with bioceramic sealer against conventional gutta-percha with bioceramic sealer in root canal obturation. A total of 60 extracted human single-canal teeth will be prepared and obturated according to standardized protocols, then evaluated for microleakage. Data will be analyzed using SPSS (version 25) with appropriate non-parametric tests at a significance level of p<0.05. The outcomes are expected to identify the more effective obturation material combination in achieving a fluid-tight seal, thereby contributing to improved success rates in endodontic therapy.
详细描述
This study will evaluate the sealing ability of bioceramic-coated gutta-percha compared with conventional gutta-percha, both used in combination with a bioceramic sealer, in single-rooted teeth. A total of 60 extracted human teeth will be prepared and divided into two groups for obturation.
A total of 60 single-canal, extracted human teeth will be selected according to inclusion and exclusion criteria through non-probability consecutive sampling. The teeth will be cleaned and shaped using ProTaper NEXT endodontic files (DENTSPLY Tulsa Dental Specialties, DENTSPLY International, Inc., USA) to size F3, then specimens will be randomly divided into two groups (n=30 each) using the lottery method.
Group I: Bioceramic sealer + Bioceramic coated GP Group II: Bioceramic sealer + conventional (non-coated) GP
Obturation will be done using the cold lateral condensation technique. All specimens will be soaked in 1% Methylene Blue dye at 37°C for seven days. Afterward, roots will be grounded (longitudinally) mesiodistally with abrasive paper or diamond slit until gutta percha and dye visible both coronally and apically. Images of each root will be taken using a digital camera (DSLR), including a mm ruler and the number label. Image J software will measure the maximum linear dye penetration (in millimeters) along the coronal and apical boundaries of teeth.
The data will be entered and analyzed using the Statistical Package for Social Sciences (SPSS, version 25). Descriptive statistics (mean ± SD) will be calculated. Differences in leakage (in mm) between the two groups will be assessed using the Kruskal-Wallis test. If significant, pairwise comparisons will be performed using the Mann-Whitney U test with Bonferroni correction. A p-value < 0.05 will be considered statistically significant. Results will be presented in tabular form.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Extracted human teeth with single canal and mature root apex
排除标准
- •Teeth with calcified (non-negotiable) canals.
- •Teeth with internal/external root resorption (as seen on radiograph)
- •Teeth with caries extending to the floor of pulp chamber.
- •Teeth with a single canal but open apex.
研究组 & 干预措施
Group I: Bioceramic sealer + Bioceramic coated GP)
Extracted single-rooted teeth obturated with bioceramic-coated gutta-percha in combination with a bioceramic sealer. This arm evaluates the sealing ability of the newer coated obturation material.
干预措施: bioceramic coated gutta percha (Procedure)
Group II (Bioceramic sealer + conventional (non-coated) GP)
Extracted single-rooted teeth obturated with conventional (non-coated) gutta-percha in combination with a bioceramic sealer. This arm serves as the reference/control to compare sealing ability against the experimental mate
干预措施: conventional(non-coated) gutta percha (Procedure)
结局指标
主要结局
post obturation leakage
时间窗: six months
assessment of leakage in obturated teeth in experimental group and control group via dye penetration method. specimens soaked in 1% methylene blue dye for seven days
次要结局
未报告次要终点
研究者
Amna Amir
Principal Investigator
Pakistan Institute of Medical Sciences
