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Cryotherapy and Intracanal Medicaments for Postoperative Pain in Apical Periodontitis

NCT07437612 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-27

No results posted yet for this study

Summary

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).

Conditions

  • Periapical Periodontitis, Chronic Nonsuppurative

Interventions

DRUG

Placement of calcium hydroxide as an intracanal medicament

Calcium hydroxide was applied into the canal after root canal shaping

DRUG

Placement of metformin as an intracanal medicament

Application of metformin as an intracanal medicament following root canal shaping

DRUG

Application of calcium hydroxide as an intracanal medicament together with intracanal cryotherapy

Intracanal cryotherapy with 4 °C sterile saline was applied after root canal shaping and before calcium hydroxide placement.

DRUG

Application of metformin into the canal together with intracanal cryotherapy

Intracanal cryotherapy with 4 °C sterile saline was applied after root canal shaping and before metformin placement.

Sponsors & Collaborators

  • Celalettin Topbaş

    lead OTHER

Principal Investigators

  • Ali O ILHAN, dds · Saglik Bilimleri University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2024-01-01
Completion
2024-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07437612 on ClinicalTrials.gov