Cryotherapy and Intracanal Medicaments for Postoperative Pain in Apical Periodontitis

Celalettin Topbaş80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Symptomatic Apical Periodontitis Pulp Necrosis

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 participants. Mandibular premolar teeth diagnosed with pulpal necrosis and symptomatic apical periodontitis and indicated for root canal treatment. Periapical index (PAI) score of 1 or 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 depth 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.

Outcomes

Primary Outcomes

Spontaneous postoperative pain on days 1 to 7

Spontaneous postoperative pain assessed daily from day 1 to day 7 using a Visual Analog Scale (VAS). Preoperative VAS score is used as a covariate in the statistical analysis.

Time frame: Days 1 through 7 post-treatment

Secondary Outcomes

Day-7 percussion pain

Percussion pain assessed on day 7 immediately before the second treatment visit using a Visual Analog Scale (VAS). Preoperative percussion VAS score is used as a covariate in the statistical analysis.

Time frame: Day 7 post-treatment