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NCT07437612
Cryotherapy and Intracanal Medicaments for Postoperative Pain in Apical Periodontitis
Phase 2 trial testing Placement of calcium hydroxide as an intracanal medicament in Periapical Periodontitis, Chronic Nonsuppurative in 80 participants. Completed in 1 January 2024.
1 January 2024
Quick facts
| Lead sponsor | Celalettin Topbaş |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 13 February 2023 |
| Primary completion | 1 January 2024 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Placement of calcium hydroxide as an intracanal medicament — full drug profile →
- Placement of metformin as an intracanal medicament — full drug profile →
- Application of calcium hydroxide as an intracanal medicament together with intracanal cryotherapy — full drug profile →
- Application of metformin into the canal together with intracanal cryotherapy — full drug profile →
Conditions studied
- Periapical Periodontitis, Chronic Nonsuppurative — all drugs for Periapical Periodontitis, Chronic Nonsuppurative →
Sponsor
Celalettin Topbaş — full company profile →
Who can join
Adults 18 to 70, any sex, with Periapical Periodontitis, Chronic Nonsuppurative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized clinical trial aimed to evaluate the effects of intracanal cryotherapy and two intracanal medicaments-calcium hydroxide and metformin-on postoperative spontaneous and percussion pain following root canal treatment in teeth with symptomatic apical periodontitis. In this double-blind, randomized, 2×2 factorial clinical trial, 80 patients with symptomatic apical periodontitis in mandibular premolars were enrolled and randomly assigned to four groups: calcium hydroxide, metformin, cryotherapy plus calcium hydroxide, and cryotherapy plus metformin. All teeth underwent standardized single-visit root canal treatment, and in the cryotherapy groups, final irrigation was performed using sterile saline at 4 °C. Spontaneous pain was assessed preoperatively and daily for 7 postoperative days, while percussion pain was evaluated preoperatively and postoperatively. Pain intensity was recorded using a 100-mm visual analog scale (VAS). Data were analyzed using mixed-effects models for repeated measures and analysis of covariance (ANCOVA) (α = 0.05).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07437612
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- ASCO Meeting Library
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07437612 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Celalettin Topbaş
- Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07437612.
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