Leakage TestingNCT07205809
Comparison of Leakage in Endodontically Treated Teeth Obturated With Different Types of Gutta Percha Coatings and Bioceramic Sealer
A study testing bioceramic coated gutta percha and conventional(non-coated) gutta percha in people with Leakage Testing, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Leakage Testing
- What is being tested?
- bioceramic coated gutta percha and conventional(non-coated) gutta percha
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Nov 2025to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1. Extracted human teeth with single canal and mature root apex
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
Islamabad, 52000
Amna Amir, BDS, amiramna351@gmail.com
Amna Amir, BDS
About this study
Official title: 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.
Read the 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.
- Conditions
- Leakage Testing
- Being tested
- bioceramic coated gutta percha, conventional(non-coated) gutta percha
- Keywords
- leakage, gutta percha, bioceramic, sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioceramic coated gutta perchaProcedure or surgery
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 perchaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: conventional(non-coated) gutta percha |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start5 Nov 2025 (estimated)
- Primary completion5 May 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leakage TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amna Amir, Pakistan Institute of Medical Sciences
- Investigators
- Amna Amir, BDS, Principal investigator, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205809
- Sponsor's protocol ID
- SOD/ERB/2025/71
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Comparison of Leakage in Endodontically Treated Teeth Obturated With Different Types of GP Coatings Using Bioceramic Sealer: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07205809
- Acronym / sponsor ID
- SOD/ERB/2025/71
- Conditions
- Leakage Testing
- Keywords
- leakage, gutta percha, bioceramic, sealer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 5 Nov 2025 (estimated)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group I: Bioceramic sealer + Bioceramic coated GP) | Experimental | Procedure: bioceramic coated gutta perchaExtracted 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. |
| Group II (Bioceramic sealer + conventional (non-coated) GP) | Active comparator | Procedure: conventional(non-coated) gutta perchaExtracted 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Extracted human teeth with single canal and mature root apex
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioceramic coated gutta perchaExperimental 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. | Procedure or surgery | Group I: Bioceramic sealer + Bioceramic coated GP) |
| conventional(non-coated) gutta perchaActive 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. | Procedure or surgery | Group II (Bioceramic sealer + conventional (non-coated) GP) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amna Amir, BDS principal investigator
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioceramic coated gutta percha and conventional(non-coated) gutta percha in people with Leakage Testing, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amna Amir, BDS (+92 335 0437279, amiramna351@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post obturation leakage (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.