Bioceramic versus resin-based root canal sealer and short-term pain
Effect of Calcium-Based Bioceramic Sealer and Resin-Based Sealer on Postoperative Pain in Adults With Asymptomatic Apical Periodontitis
This will test whether a calcium-based bioceramic sealer or a resin-based sealer causes less short-term pain after root canal treatment in adults with asymptomatic apical periodontitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Fatima Memorial Hospital Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07256691 on ClinicalTrials.gov |
What this trial studies
In this randomized trial, 60 adults (ages 18–55) with non-vital teeth and radiographic periapical lesions (PAI 2–4) will receive root canal treatment using either a calcium-based bioceramic sealer or a resin-based sealer with single-cone Gutta-percha obturation. Standard cleaning, shaping, irrigation, and obturation procedures are used and patients are randomized to one of the two sealer groups. Postoperative pain is recorded on a 0–10 Numeric Pain Rating Scale at 4, 24, and 48 hours, and the highest reported score determines outcome categories (none, mild, moderate, severe). Patients with severe pain (8–10) are classified as treatment failures, and others as successes.
Who should consider this trial
Good fit: Adults aged 18–55 with non-vital teeth, fully formed apices, asymptomatic apical periodontitis (PAI 2–4), and the ability to report pain scores are eligible.
Not a fit: Patients with systemic medical conditions, periodontally compromised teeth, unreadable working length, open apices, or those who experience treatment complications are excluded and unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could help clinicians choose a sealer that reduces short-term postoperative pain and improves patient comfort after root canal treatment.
How similar studies have performed: Previous small clinical and laboratory studies comparing bioceramic and resin-based sealers have shown mixed results, with some suggesting similar or slightly lower postoperative pain with bioceramic sealers but no clear consensus.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Lahore, Punjab Province
- Fatima Memorial Hospital — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Shehryar Khan, Bachelor Of Dental SURGERY
- Email: shehryar_jadun@yahoo.com
- Phone: +92 336 9892535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.