Postoperative pain after root canal filling with bioceramic versus calcium hydroxide sealers.
Assessment of Postoperative Pain in Patients Obturated With Bioceramic and Calcium Hydroxide Sealers: A Randomized Clinical Trial
We are testing whether using a bioceramic or a calcium hydroxide root canal sealer leads to less pain after root canal treatment in people with symptomatic irreversible pulpitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | HITEC-Institute of Medical Sciences Academic / other |
| Locations | 1 site (Rawalpindi, Punjab Province) |
| Trial ID | NCT07410780 on ClinicalTrials.gov |
What this trial studies
This randomized, single-blind clinical trial will enroll 50 adults with symptomatic irreversible pulpitis and randomly assign them to receive either a bioceramic (calcium silicate-based) sealer or a calcium hydroxide-based sealer during single-visit root canal treatment. All procedures will be performed by the same operator under local anesthesia and rubber dam isolation, with standardized canal preparation and irrigation. Participants will report postoperative pain levels for several days after the procedure to compare early discomfort between the two sealers. The trial is conducted at the Department of Operative Dentistry, HITEC-IMS Dental College in Rawalpindi.
Who should consider this trial
Good fit: Adults aged 18–40 with a single-rooted, restorable permanent tooth diagnosed with symptomatic irreversible pulpitis and normal periapical radiographs (or only PDL widening) are ideal candidates.
Not a fit: Patients with necrotic pulp, immature roots, root resorption, calcified canals, systemic conditions affecting treatment, multi-rooted teeth, or those outside the 18–40 age range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help dentists choose a sealer that reduces short-term pain and improves comfort after root canal treatment.
How similar studies have performed: Previous clinical and laboratory studies comparing bioceramic and calcium hydroxide-based sealers have produced mixed but generally promising results, with some trials reporting reduced postoperative pain using bioceramic sealers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-40 years * Single-rooted permanent teeth * Teeth diagnosed with symptomatic irreversible pulpitis * Normal periapical condition on radiographic examination or periodontal ligament (PDL) space widening * Restorable teeth Exclusion Criteria: * Patients with systemic conditions that could alter the course of treatment * Teeth with immature root development * Teeth with necrotic pulp * Teeth exhibiting root resorption * Teeth with calcified root canals
Where this trial is running
Rawalpindi, Punjab Province
- Department of Operative Dentistry, HITEC-IMS Dental College — Rawalpindi, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Monal Fatima — HITEC-IMS, Department of Operative Dentistry, Taxila, Pakistan
- Study coordinator: Monal Fatima, BDS
- Email: manalfatima1100@gmail.com
- Phone: 03004410676
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.