Cryotherapy and Intracanal Medicaments for Postoperative Pain in Apical Periodontitis

Celalettin Topbaş80 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periapical Periodontitis, Chronic Nonsuppurative

Interventions

Placement of calcium hydroxide as an intracanal medicamentDRUG

Calcium hydroxide was applied into the canal after root canal shaping

Placement of metformin as an intracanal medicamentDRUG

Application of metformin as an intracanal medicament following root canal shaping

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

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

Application of metformin into the canal together with intracanal cryotherapyDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * systemically healthy * Mandibular premolar teeth diagnosed with pulpal necrosis and indicated for root canal treatment. * Periapical index score between 0 and 2. * Aged between 18 and 70 years. * Able to understand and complete visual analog scale (VAS) assessments. * Provided written informed consent. Exclusion Criteria: * Any systemic disease or pregnancy. * Use of analgesics within 24 hours prior to treatment. * Severe bruxism. * Presence of acute apical abscess or swelling. * Periodontal pocket depths greater than 5 mm or tooth mobility exceeding grade 1. * Teeth deemed unrestorable. * Presence of vital pulpal tissue or immature apices * Radiographic evidence of root resorption, root fracture, perforation, or canal calcification.

Locations (1)

Saglik Bilimleri University

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Postoperative spontaneous pain

Assessed using a 100-mm Visual Analog Scale (VAS) A score of 0 represents no pain, while a score of 100 represents the maximum pain. Patients were instructed to document pain levels prior to taking any analgesic medication

Time frame: Preoperatively and days 1 to 7

Secondary Outcomes

Percussion pain

Assessed using a 100-mm Visual Analog Scale (VAS) A score of 0 represents no pain, while a score of 100 represents the maximum pain Recorded preoperatively and postoperatively

Time frame: Preoperatively and postoperative day 7

Data from ClinicalTrials.gov

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