Asymptomatic Apical PeriodontitisNCT07256691
Effect of Calcium-Based Bioceramic Sealer and Resin-Based Sealer on Postoperative Pain
A study testing Resin-based sealer obturation technique and Bioceramic sealer obturation in people with Asymptomatic Apical Periodontitis, run by Fatima Memorial Hospital at 1 site in Pakistan.
Trial summary
This study aims to compare the effect of calcium-based bioceramic sealer and resin-based sealer on postoperative pain in adult patients with asymptomatic apical periodontitis undergoing root canal treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asymptomatic Apical Periodontitis
- What is being tested?
- Resin-based sealer obturation technique and Bioceramic sealer obturation
- 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
- 1 Dec 2025to 28 Feb 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders.
- Teeth diagnosed with asymptomatic apical periodontitis.
- Teeth are asymptomatic (no pain on percussion or palpation).
- Non-vital pulp (no response on Electric Pulp Testing).
- Teeth with fully formed apices.
- Teeth with Periapical Index (PAI) scores 2-4 on radiographs.
Who cannot join
- Medically compromised patients (e.g., those with immunosuppressive or systemic diseases, or on medications that may affect healing).
- Patients who refuse to participate or are unable to communicate their symptoms (e.g., due to psychological disorders).
- Teeth where full working length cannot be reached.
- Periodontally compromised teeth (probing depth >4 mm).
- Complications during treatment (e.g., separation of a file, ledging).
- Overfilling (filling beyond the radiographic apex) or short filling (>2 mm from the radiographic 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, 1 recruiting
- Recruiting
Fatima Memorial Hospital
Lahore, Punjab Province, 54000
SHEHRYAR KHAN SHEHRYAR KHAN, BACHELOR OF DENTAL SURGERY, +923369892535, shehryar_jadun@yahoo.com
About this study
Official title: Effect of Calcium-Based Bioceramic Sealer and Resin-Based Sealer on Postoperative Pain in Adults With Asymptomatic Apical Periodontitis
This study aims to compare the effect of calcium-based bioceramic sealer and resin-based sealer on postoperative pain in adult patients with asymptomatic apical periodontitis undergoing root canal treatment. Asymptomatic apical periodontitis is a condition where the tissue around the tip of the tooth root is inflamed or shows a lesion on X-ray, but the patient does not experience pain.
A total of 60 patients will be randomly assigned to receive root canal treatment with either the bioceramic sealer (Group A) or the resin-based sealer (Group B). Pain after treatment will be measured using a 0-10 Numeric Pain Rating Scale at 4, 24, and 48 hours post-treatment. The highest pain score reported will determine whether the treatment is considered a success (no or mild/moderate pain) or failure (severe pain).
The results of this study will provide evidence on which sealer is associated with less postoperative pain, helping clinicians make informed decisions about root canal filling materials.
Read the detailed description
This randomized controlled clinical trial aims to compare calcium-based bioceramic sealer and resin-based sealer in root canal treatment for adult patients with asymptomatic apical periodontitis. Asymptomatic apical periodontitis is a condition where the tissue around the tip of the tooth root is inflamed or shows a lesion on X-ray, but the patient does not feel pain.
A total of 60 patients aged 18-55 years will be recruited at the Department of Operative Dentistry, Fatima Memorial Hospital, Lahore. Eligible patients will have non-vital teeth with fully formed roots and periapical lesions classified as PAI scores 2-4. Patients with systemic diseases, periodontally compromised teeth, or complications during treatment will be excluded.
Patients will be randomly assigned to two groups: Group A will receive root canal obturation using bioceramic sealer, and Group B will receive resin-based sealer. The treatment procedure involves standard root canal cleaning and shaping, irrigation, and obturation using a single-cone technique with Gutta-percha.
Postoperative pain will be assessed using a Numeric Pain Rating Scale (0-10) at 4, 24, and 48 hours after obturation. The highest pain score reported across these time points will determine the outcome. Pain levels will be classified as: None (0), Mild (1-3), Moderate (4-7), or Severe (8-10). Patients with severe pain (8-10) will be considered treatment failures, while all others will be considered treatment successes.
Data will be analyzed using SPSS. Descriptive statistics will summarize demographic and clinical variables, and Chi-square tests will compare postoperative pain between groups. The study aims to provide evidence on which sealer results in less postoperative pain, supporting better clinical decision-making in endodontics.
- Conditions
- Asymptomatic Apical Periodontitis
- Being tested
- Resin-based sealer obturation technique, Bioceramic sealer obturation
- Keywords
- Bioceramic sealer, Resin-based sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin-based sealer obturation techniqueProcedure or surgery
Root canal obturation using resin based sealer with single cone GP technique. Canals prepared and irrigated as above. Pain recorded at 4, 24, and 48 hours post-obturation using NPRS.
Bioceramic sealer obturationProcedure or surgery
Participants in this group will undergo root canal obturation using a calcium silicate based bioceramic sealer with a single-cone gutta percha technique. After standard canal preparation and irrigation with 2.5% sodium hypochlorite, the canals will be dried with paper points. The bioceramic sealer will be applied using a lentulospiral or directly coated on the master gutta-percha cone. A matched-taper gutta-percha cone will then be inserted to full working length. The canal orifice will be sealed with a temporary or permanent restoration. Postoperative pain will be assessed at 4, 24, and 48 hours using the Numeric Pain Rating Scale (NPRS).
| Study group | Role | What they receive |
|---|---|---|
| Bioceramic Sealer Group | Experimental | Patients in this group will receive root canal obturation using bioceramic (calcium silicate-based) sealer with gutta-percha. Postoperative pain will be assessed at 4, 24, and 48 hours using the Numeric Pain Rating Scale (NPRS). Receives: Procedure: Bioceramic sealer obturation |
| Resin-Based Sealer Group | Experimental | Patients in this group will receive root canal obturation using resin-based sealer with gutta-percha. Postoperative pain will be assessed at 4, 24, and 48 hours using the Numeric Pain Rating Scale (NPRS). Receives: Procedure: Resin-based sealer obturation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain intensity will be measured using the Numeric Pain Rating Scale (0-10). The highest score among the three time points will determine outcome. Scores 0-7 are considered successful; 8-10 indicate failure.
Measured: 4, 24, and 48 hours after root canal obturation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Dec 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Apical PeriodontitisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHEHRYAR KHAN, Fatima Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256691
- Sponsor's protocol ID
- FMH-13/06/2025-IRB-1673
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD shared will include demographic information, clinical findings, pain scores, and treatment details for each patient.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium-Based Bioceramic Sealer and Resin-Based Sealer on Postoperative Pain in Adults With Asymptomatic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07256691
- Acronym / sponsor ID
- FMH-13/06/2025-IRB-1673
- Conditions
- Asymptomatic Apical Periodontitis
- Keywords
- Bioceramic sealer, Resin-based sealer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fatima Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 1 Dec 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.
This study aims to compare the effect of calcium-based bioceramic sealer and resin-based sealer on postoperative pain in adult patients with asymptomatic apical periodontitis undergoing root canal treatment. Asymptomatic apical periodontitis is a condition where the tissue around the tip of the tooth root is inflamed or shows a lesion on X-ray, but the patient does not experience pain.
A total of 60 patients will be randomly assigned to receive root canal treatment with either the bioceramic sealer (Group A) or the resin-based sealer (Group B). Pain after treatment will be measured using a 0-10 Numeric Pain Rating Scale at 4, 24, and 48 hours post-treatment. The highest pain score reported will determine whether the treatment is considered a success (no or mild/moderate pain) or failure (severe pain).
The results of this study will provide evidence on which sealer is associated with less postoperative pain, helping clinicians make informed decisions about root canal filling materials.
Detailed description
This randomized controlled clinical trial aims to compare calcium-based bioceramic sealer and resin-based sealer in root canal treatment for adult patients with asymptomatic apical periodontitis. Asymptomatic apical periodontitis is a condition where the tissue around the tip of the tooth root is inflamed or shows a lesion on X-ray, but the patient does not feel pain.
A total of 60 patients aged 18-55 years will be recruited at the Department of Operative Dentistry, Fatima Memorial Hospital, Lahore. Eligible patients will have non-vital teeth with fully formed roots and periapical lesions classified as PAI scores 2-4. Patients with systemic diseases, periodontally compromised teeth, or complications during treatment will be excluded.
Patients will be randomly assigned to two groups: Group A will receive root canal obturation using bioceramic sealer, and Group B will receive resin-based sealer. The treatment procedure involves standard root canal cleaning and shaping, irrigation, and obturation using a single-cone technique with Gutta-percha.
Postoperative pain will be assessed using a Numeric Pain Rating Scale (0-10) at 4, 24, and 48 hours after obturation. The highest pain score reported across these time points will determine the outcome. Pain levels will be classified as: None (0), Mild (1-3), Moderate (4-7), or Severe (8-10). Patients with severe pain (8-10) will be considered treatment failures, while all others will be considered treatment successes.
Data will be analyzed using SPSS. Descriptive statistics will summarize demographic and clinical variables, and Chi-square tests will compare postoperative pain between groups. The study aims to provide evidence on which sealer results in less postoperative pain, supporting better clinical decision-making in endodontics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioceramic Sealer Group | Experimental | Procedure: Bioceramic sealer obturationPatients in this group will receive root canal obturation using bioceramic (calcium silicate-based) sealer with gutta-percha. Postoperative pain will be assessed at 4, 24, and 48 hours using the Numeric Pain Rating Scale (NPRS). |
| Resin-Based Sealer Group | Experimental | Procedure: Resin-based sealer obturation techniquePatients in this group will receive root canal obturation using resin-based sealer with gutta-percha. Postoperative pain will be assessed at 4, 24, and 48 hours using the Numeric Pain Rating Scale (NPRS). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both genders.
- Teeth diagnosed with asymptomatic apical periodontitis.
- Teeth are asymptomatic (no pain on percussion or palpation).
- Non-vital pulp (no response on Electric Pulp Testing).
- Teeth with fully formed apices.
Key exclusion criteria (6 listed)
- Medically compromised patients (e.g., those with immunosuppressive or systemic diseases, or on medications that may affect healing).
- Patients who refuse to participate or are unable to communicate their symptoms (e.g., due to psychological disorders).
- Teeth where full working length cannot be reached.
- Periodontally compromised teeth (probing depth >4 mm).
- Complications during treatment (e.g., separation of a file, ledging).
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 |
|---|---|---|
| Resin-based sealer obturation techniqueRoot canal obturation using resin based sealer with single cone GP technique. Canals prepared and irrigated as above. Pain recorded at 4, 24, and 48 hours post-obturation using NPRS. | Procedure or surgery | Resin-Based Sealer Group |
| Bioceramic sealer obturationParticipants in this group will undergo root canal obturation using a calcium silicate based bioceramic sealer with a single-cone gutta percha technique. After standard canal preparation and irrigation with 2.5% sodium hypochlorite, the canals will be dried with paper points. The bioceramic sealer will be applied using a lentulospiral or directly coated on the master gutta-percha cone. A matched-taper gutta-percha cone will then be inserted to full working length. The canal orifice will be sealed with a temporary or permanent restoration. Postoperative pain will be assessed at 4, 24, and 48 hours using the Numeric Pain Rating Scale (NPRS). | Procedure or surgery | Bioceramic Sealer Group |
Primary outcome
Postoperative pain
Time frame: 4, 24, and 48 hours after root canal obturation.
Pain intensity will be measured using the Numeric Pain Rating Scale (0-10). The highest score among the three time points will determine outcome. Scores 0-7 are considered successful; 8-10 indicate failure.
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 24 Dec 2025.
- Individual participant dataSharing planned: Yes. The IPD shared will include demographic information, clinical findings, pain scores, and treatment details for each patient.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin-based sealer obturation technique and Bioceramic sealer obturation in people with Asymptomatic Apical Periodontitis, run by Fatima Memorial Hospital 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Dec 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 Shehryar Khan, Bachelor Of Dental SURGERY (+92 336 9892535, shehryar_jadun@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 4, 24, and 48 hours after root canal obturation.). 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 24 Dec 2025.