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

NCT07205809 | Not Yet Recruiting

• 1 other identifier: SOD/ERB/2025/71
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leakage Testing

Keywords

leakage; gutta percha; bioceramic; sealer

Outcome Measures

Primary Outcomes (1)

• post obturation leakage

  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

Study Arms (2)

Group I: Bioceramic sealer + Bioceramic coated GP)

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

bioceramic coated gutta percha PROCEDURE

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 I: Bioceramic sealer + Bioceramic coated GP)

conventional(non-coated) gutta percha PROCEDURE

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.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

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

Islamabad, 52000, Pakistan

Location

MeSH Terms

Interventions

Gutta-Percha

Intervention Hierarchy (Ancestors)

Plant Exudates; Biological Products; Complex Mixtures; Root Canal Filling Materials; Dental Materials; Biomedical and Dental Materials; Rubber; Elastomers; Polymers; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Amna Amir, BDS

  School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amna Amir, BDS

CONTACT

+92 335 0437279; amiramna351@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be an in vitro experimental study conducted on extracted human teeth. A total of 60 single-rooted teeth will be collected according to inclusion and exclusion criteria. Using a non-probability consecutive sampling technique, the teeth will be instrumented with ProTaper NEXT files up to size F3 and then divided into two groups (n=30 each). Group 1 will be obturated with bioceramic sealer and bioceramic-coated gutta-percha, while Group 2 will be obturated with bioceramic sealer and conventional gutta-percha. Microleakage will be evaluated in millimeters and the data analyzed using SPSS (version 25). This model allows for controlled comparison of sealing ability between the two obturation techniques.

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: November 5, 2025
• Primary Completion: May 5, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)