Postoperative pain after root canal filling using two different bio-ceramic sealers
| ISRCTN | ISRCTN70977847 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70977847 |
| Sponsor | Al Baha University |
| Funder | Investigator initiated and funded |
- Submission date
- 28/06/2026
- Registration date
- 30/06/2026
- Last edited
- 30/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Postoperative pain is a common complication after root canal therapy. Bioceramic root canal sealers are widely used due to their excellent biological properties, but clinical data comparing specific brands remains limited. This study aims to evaluate and compare the incidence and intensity of postoperative pain following root canal treatment using two different bioceramic sealers: Bio-C Sealer and TotalFill BC Sealer.
Who can participate?
Medically healthy patients aged 18 years and older requiring non-surgical root canal treatment on a restorable tooth with a normal periapical appearance or a small periapical lesion (<2 mm)
What does the study involve?
Participants are randomly assigned to one of two groups to receive root canal filling using either Bio-C Sealer or TotalFill BC Sealer. Patients and clinicians are blinded to the sealer type used. Following the procedure, patients record their pain levels at 24 hours, 48 hours, 72 hours, and 7 days after treatment.
What are the possible benefits and risks of participating?
Participants benefit from receiving high-standard endodontic treatment with advanced bioactive materials. The primary risk is mild-to-severe postoperative pain, which is a standard complication of root canal therapy and can be managed with standard over-the-counter pain relievers.
Where is the study run from?
Al-Baha University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
March 2025 to December 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mohammed S. Alzahrani, m.sarhan@bu.edu.sa
Contact information
Principal investigator, Scientific, Public
65732
Albaha
4728
Saudi Arabia
 ORCID ID |
0000-0001-8078-8309 |
|---|---|
| Phone | 0543291242 |
| m.sarhan@bu.edu.sa |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Single |
| Purpose | Treatment |
| Scientific title | Postoperative pain after root canal filling with different bio-ceramic endodontic sealers: a double-blind randomised clinical trial |
| Study objectives | To evaluate the effect of two different bioceramic sealers on post-obturation pain. Specifically, the incidence of postoperative pain will be compared following the use of randomly assigned TotalFill® BC Sealer or Bio-C Sealer over a 7-day period after endodontic treatment. |
| Ethics approval(s) |
Approved 06/03/2025, Research Ethics Committee of Al-Baha University (BASA7438, 7438 Al-Baha University 3, 4577, Al Jamiah Dist., AL AQIQ, Bahah, Albaha, 65779, Saudi Arabia; +966 (0)17 7257700; contact@bu.edu.sa), ref: 2025/46113615 |
| Health condition(s) or problem(s) studied | Post root canal treatment pain |
| Intervention | Non-surgical root canal treatment with two different types of tricalcium silicate sealers (TotalFill® BC Sealer or Bio-C) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 15/12/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Willing to participate and provide informed con-sent 2. Required root canal treatment 3. Medically healthy (American Society of Anesthesiologists [ASA] Class I or II) 4. Aged 18 years or older 5. Normal periapical radiographic appearance or a periapical lesion <2 mm 6. Restorable tooth 7. Periodontally healthy tooth |
| Key exclusion criteria | 1. Under 18 years of age 2. Pregnant 3. Declined participation 4. Previously endodontically treated tooth 5. Tooth with an open apex 6. Presence of a deep isolated periodontal pocket 7. Tooth fracture 8. Root resorption 9. Endo-perio lesion 10. Non-restorable tooth 11. Tooth with mishaps |
| Date of first enrolment | 15/03/2025 |
| Date of final enrolment | 15/06/2025 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
30/06/2026: Study's existence confirmed by the Research Ethics Committee of Al-Baha University.
