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

Pakistan Institute of Medical Sciences

Status: Not yet enrolling

Conditions: Leakage Testing

Treatments: Procedure: bioceramic coated gutta percha; Procedure: conventional(non-coated) gutta percha

Study type: Interventional

Funder types: Other

Identifiers

NCT07205809

SOD/ERB/2025/71

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Teeth with calcified (non-negotiable) canals.
2. Teeth with internal/external root resorption (as seen on radiograph)
3. Teeth with caries extending to the floor of pulp chamber.
4. Teeth with a single canal but open apex.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group I: Bioceramic sealer + Bioceramic coated GP)

Experimental group

Description:

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.

Treatment:

Procedure: bioceramic coated gutta percha

Group II (Bioceramic sealer + conventional (non-coated) GP)

Active Comparator group

Description:

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

Treatment:

Procedure: conventional(non-coated) gutta percha