Calcium hydroxide versus Bio‑C Temp for pain after multi-visit root canal retreatment
Comparative Evaluation of the Effects of Calcium Hydroxide and BIO-C Temp Medicaments on Postoperative Pain in Patients Undergoing Endodontic Treatment: a Clinical Study
This will test whether using Bio‑C Temp instead of calcium hydroxide between visits reduces pain for adults having multi-visit root canal retreatment of a single-rooted tooth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara University Academic / other |
| Locations | 2 sites (Ankara, Ankara and 1 other locations) |
| Trial ID | NCT07396688 on ClinicalTrials.gov |
What this trial studies
This comparative clinical study enrolls systemically healthy adults (ASA I) who require multi-visit endodontic retreatment of single-rooted teeth and assigns them to receive either calcium hydroxide or a bioceramic intracanal medicament (Bio‑C Temp) between appointments. Postoperative pain between visits is recorded using patient-reported measures such as a visual analogue scale. Teeth with complex anatomy, fractures, recent antibiotic or analgesic use, pregnancy, or systemic disease are excluded. The study aims to determine whether the choice of intracanal medicament influences interappointment pain and patient comfort.
Who should consider this trial
Good fit: Adults in good general health (ASA I) who need multi-visit endodontic retreatment of a single-rooted tooth with normal root anatomy are ideal candidates.
Not a fit: Patients with multirooted or complex root anatomy, root fractures/perforations, recent antibiotic/analgesic use, pregnancy, systemic disease, or high baseline treatment‑resistant pain were excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce pain and improve comfort between root canal retreatment visits.
How similar studies have performed: Laboratory data and limited clinical reports suggest bioceramic medicaments are biocompatible, but clinical evidence directly comparing interappointment pain with calcium hydroxide is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Patients with single-rooted teeth requiring endodontic retreatment. * Individuals in good general health, classified as ASA Physical Status I. * Teeth presenting normal anatomical structure and root morphology. Exclusion Criteria: * • Patients who have used antibiotics or analgesic medications within the last month. * Pregnant individuals and patients with systemic diseases (such as chronic illnesses, diabetes mellitus, hypertension). * Teeth with root fractures or perforations. * Teeth with complex root canal anatomy, multirooted teeth, or severely curved roots. * Patients presenting with high baseline pain levels, particularly those with a history of treatment-resistant pain.
Where this trial is running
Ankara, Ankara and 1 other locations
- Ankara University Faculty of Dentistry — Ankara, Ankara, Turkey (Türkiye) (Recruiting)
- Ankara University Faculty of Dentistry — Ankara, Ankara, Turkey (Türkiye) (Recruiting)
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.