Effect of Calcium-Based Bioceramic Sealer and Resin-Based Sealer on Postoperative Pain (NCT07256691) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Calcium-Based Bioceramic Sealer and Resin-Based Sealer on Postoperative Pain
Pakistan60 participantsStarted 2025-12-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:Age 18-55 years.
* 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.
Exclusion Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative pain
Timeframe: 4, 24, and 48 hours after root canal obturation.