drugset / Trial / NCT07437612

Cryotherapy and Intracanal Medicaments for Postoperative Pain in Apical Periodontitis

NCT07437612 ↗

Completed 80 enrolled Celalettin Topbaş
RandomizedFactorialDouble-blindTreatment

Summary

This randomized, participant- and outcome assessor-blinded, 2 × 2 factorial clinical trial evaluated the effects of intracanal cryotherapy and two intracanal medicaments-calcium hydroxide and metformin-on postoperative spontaneous and percussion pain in mandibular premolars with pulpal necrosis and symptomatic apical periodontitis. Eighty participants were randomly assigned to four groups: calcium hydroxide, metformin, cryotherapy plus calcium hydroxide, and cryotherapy plus metformin. All teeth underwent standardized two-visit root canal treatment. In the cryotherapy groups, final irrigation at the first treatment visit was performed using sterile saline at 4 °C. Spontaneous pain was assessed preoperatively and daily for 7 postoperative days using a 100-mm visual analog scale (VAS). Percussion pain was assessed preoperatively and on day 7 immediately before the second treatment visit. The effects of cryotherapy, intracanal medicament type, and their interaction were evaluated using mixed-effects modeling for spontaneous pain and analysis of covariance (ANCOVA) for day-7 percussion pain.

Timeline

Start
2023-03-01
Primary completion
2024-01-01
Completion
2024-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Calcium Hydroxide Other / unclassified — Other
Comparator Metformin Small molecule — Other