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Effects of Irrigation Solutions at Different Temperatures Used in Mandibular Third Molar Surgery

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
The present study aims to compare the effects of saline, chlorhexidine, and hydrogen peroxide irrigation solutions at different temperatures on postoperative complications, including pain, swelling, and mouth opening, as well as oral health-related quality of life, in patients undergoing surgical extraction of impacted mandibular third molars. The irrigation solutions will be applied immediately following surgical tooth extraction at temperatures of either 4°C or 25°C. An a prior power analysis based on repeated-measures analysis of variance (Repeated Measures ANOVA, within-between interaction) was performed. An effect size of f = 0.25, a Type I error rate (α = 0.05), and a statistical power of 1 - β = 0.95 were assumed. Based on the power analysis, a minimum of 11 participants per group was determined to be sufficient. Considering potential loss to follow-up and missing data, the sample size was increased by approximately 15%, and it was decided to enroll 13 participants in each group. Accordingly, the planned study will be conducted with a total of 78 participants allocated to six groups, and all participants will be evaluated at four different time points.
Trial Details
NCT Number NCT07835958
Lead Sponsor Saglik Bilimleri Universitesi
Conditions
(from sponsor)		 Third Molars Extraction, Oral Health-Related Quality of Life, Postoperative Complications in Maxillofacial Surgery, Irrigation Solution
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov