Comparison of Leakage in Endodontically Treated Teeth Obturated With Different Types of Gutta Percha Coatings and Bioceramic Sealer
NCT ID: NCT07205809
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-11-05
2026-06-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
ALL
Yes
Sponsors
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Pakistan Institute of Medical Sciences
OTHER_GOV
Responsible Party
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Amna Amir
Principal Investigator
Principal Investigators
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Amna Amir, BDS
Role: PRINCIPAL_INVESTIGATOR
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
Locations
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School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
Islamabad, , Pakistan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SOD/ERB/2025/71
Identifier Type: -
Identifier Source: org_study_id
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