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Completed

NCT Number: NCT07437612

Cryotherapy and Intracanal Medicaments for Postoperative Pain in Apical Periodontitis

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).

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Key information

Conditions

Periapical Periodontitis, Chronic Nonsuppurative Jaw Diseases Mouth Diseases Periapical Diseases Periapical Granuloma Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saglik Bilimleri University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placement of calcium hydroxide as an intracanal medicament

Drug

Calcium hydroxide was applied into the canal after root canal shaping

Placement of metformin as an intracanal medicament

Drug

Application of metformin as an intracanal medicament following root canal shaping

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

Drug

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 cryotherapy

Drug

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

Primary outcomes

  1. Postoperative spontaneous pain

    Time frame: Preoperatively and days 1 to 7

    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

Secondary outcomes

  1. Percussion pain

    Time frame: Preoperatively and postoperative day 7

    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

Sponsors and collaborators

Lead sponsor

Celalettin Topbaş

Other

Registry information

Official study title

Effect of Intracanal Cryotherapy and Metformin on Postoperative Pain in Teeth With Symptomatic Apical Periodontitis: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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