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

September 26, 2025 updated by: Amna Amir, Pakistan Institute of Medical Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 52000
        • School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
        • Contact:
        • Principal Investigator:
          • Amna Amir, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Active Comparator: 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
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post obturation leakage
Time Frame: 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
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Medical Sciences

Investigators

  • Principal Investigator: Amna Amir, BDS, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 5, 2025

Primary Completion (Estimated)

May 5, 2026

Study Completion (Estimated)

June 12, 2026

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

September 26, 2025

First Posted (Actual)

October 3, 2025

Study Record Updates

Last Update Posted (Actual)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOD/ERB/2025/71

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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