4°C sterile saline solution: Patients whose extraction sockets will be irrigated with 4°C sterile saline solution following mandibular third molar surgery.
25°C sterile saline solution: Patients whose extraction sockets will be irrigated with 25°C sterile saline solution following mandibular third molar surgery.
4°C 0.2% chlorhexidine solution: Patients whose extraction sockets will be irrigated with 4°C 0.2% chlorhexidine solution following mandibular third molar surgery.
25°C 0.2% chlorhexidine solution: Patients whose extraction sockets will be irrigated with 25°C 0.2% chlorhexidine solution following mandibular third molar surgery.
4°C 1.5% hydrogen peroxide solution: Patients whose extraction sockets will be irrigated with 4°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.
25°C 1.5% hydrogen peroxide solution: Patients whose extraction sockets will be irrigated with 25°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Presence of a unilateral or bilateral impacted mandibular third molar classified as Class II, Position B according to the Pell and Gregory classification), indicating that there is insufficient space in the jaw for eruption of the tooth and that the cervical line of the impacted tooth is at the level of the cervical line of the adjacent second molar.
* Systemically healthy individuals classified as ASA Physical Status I.
* Age between 18 and 35 years.
* Willingness to participate in the study.
Exclusion Criteria:
* Individuals outside the specified age range.
* Pregnant individuals.
* Individuals who are currently breastfeeding.
* Presence of clinical signs of infection in the region of the impacted third molar, including acute pericoronitis.
* Presence of any systemic disease that may affect wound healing, including metabolic, immunological, or endocrine disorders.
* Presence of a cystic or tumoral lesion associated with the impacted third molar.
* History of allergy, hypersensitivity, or intolerance to chlorhexidine gluconate or hydrogen peroxide solutions to be used in the study.
* Unwillingness to participate in the study.
* Poor oral hygiene at a level that may adversely affect wound healing.
* Cold intolerance or the presence or history of cold-related diseases, including Raynaud's disease, cold urticaria, or cryoglobulinemia.
* Use of systemic antibiotics, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs) within the previous two weeks.
* Cases in which no bone removal is required during surgery.
* Patients who meet the inclusion criteria but are unwilling to participate in the study.
Primary outcome measure(s)
Postoperative Edema (Swelling) — Preoperatively and on postoperative days 2, 4, and 7 Edema will be measured along five predetermined anatomical reference lines using a flexible millimeter ruler. Measurements will be recorded in millimeters.
Postoperative Pain — Preoperative and postoperative days 2, 4, and 7 using a 10-cm VAS. Postoperative pain will be assessed by Visual Analog Scale (VAS). The amount of analgesic required by each patient during the postoperative period will be recorded daily on the patient follow-up form.
Trismus (Restriction of Mouth Opening) — Preoperative day and postoperative days 2, 4, and 7 Maximum mouth opening will be measured in millimeters using a digital caliper.
Trial sites (1)
Facility
City
Region
Status
University of Health Sciences, Keciören, Ankara
Ankara
Turkey (Türkiye)
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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