Comparison of Leakage in Endodontically Treated Teeth Obturated With Different Types of Gutta Percha Coatings and Bioceramic Sealer

Официальное название

In Vitro Comparison of Leakage in Endodontically Treated Teeth Obturated With Different Types of GP Coatings Using Bioceramic Sealer: A Randomized Controlled Trial.

Обзор

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.

Подробное описание

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.

Microleakage will be measured and statistically analyzed to determine the more effective material combination for achieving a fluid-tight seal in root canal therapy.

Вмешательства

• Процедура bioceramic coated gutta percha
  Experimental Arm (Bioceramic-coated GP + Bioceramic Sealer): Specimens will be obturated using bioceramic-coated gutta-percha cones in combination with bioceramic sealer after canal preparation with ProTaper NEXT files up to size F3.
• Процедура conventional(non-coated) gutta percha
  Active Comparator Arm (Conventional GP + Bioceramic Sealer): Specimens will be obturated using conventional (non-coated) gutta-percha cones in combination with the same bioceramic sealer after canal preparation with ProTaper NEXT files up to size F3.

Первичные конечные точки

• post obturation leakage [Срок оценки: six months]

Критерии участия

Критерии включения

1\. Extracted human teeth with single canal and mature root apex

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad — Islamabad

Идентификаторы

NCT: NCT07205809 · SOD/ERB/2025/71

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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