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

NCT07835958 | Not Yet Recruiting

• 2 other identifiers: 2026-300Academician
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Third Molars Extraction; Oral Health-Related Quality of Life; Postoperative Complications in Maxillofacial Surgery; Irrigation Solution

Keywords

third molar extraction; oral health related quality of life; postoperative complications in maxillofacial surgery; irrigation solution

Outcome Measures

Primary Outcomes (3)

• Postoperative Edema (Swelling)

  Edema will be measured along five predetermined anatomical reference lines using a flexible millimeter ruler. Measurements will be recorded in millimeters.

  Preoperatively and on postoperative days 2, 4, and 7

• Postoperative Pain

  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.

  Preoperative and postoperative days 2, 4, and 7 using a 10-cm VAS.

• Trismus (Restriction of Mouth Opening)

  Maximum mouth opening will be measured in millimeters using a digital caliper.

  Preoperative day and postoperative days 2, 4, and 7

Secondary Outcomes (1)

• Oral Health Related Quality of Life (QoL)

  Preoperatively and on postoperative days 2, 4, and 7.

Study Arms (6)

4°C sterile saline solution

EXPERIMENTAL

Patients whose extraction sockets will be irrigated with 4°C sterile saline solution following mandibular third molar surgery.

Procedure: 4°C sterile saline solution

25°C sterile saline solution

EXPERIMENTAL

Patients whose extraction sockets will be irrigated with 25°C sterile saline solution

Procedure: 25°C sterile saline solution

4°C 0.2% chlorhexidine solution

EXPERIMENTAL

Patients whose extraction sockets will be irrigated with 4°C 0.2% chlorhexidine solution following mandibular third molar surgery.

Procedure: 4°C 0.2% chlorhexidine solution

25°C 0.2% chlorhexidine solution

EXPERIMENTAL

Patients whose extraction sockets will be irrigated with 25°C 0.2% chlorhexidine solution following mandibular third molar surgery.

Procedure: 25°C 0.2% chlorhexidine solution

4°C 1.5% hydrogen peroxide solution

EXPERIMENTAL

Patients whose extraction sockets will be irrigated with 4°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.

Procedure: 4°C 1.5% hydrogen peroxide solution

25°C 1.5% hydrogen peroxide solution

EXPERIMENTAL

Patients whose extraction sockets will be irrigated with 25°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.

Procedure: 25°C 1.5% hydrogen peroxide solution

Interventions

4°C sterile saline solution PROCEDURE

Patients whose extraction sockets will be irrigated with 4°C sterile saline solution following mandibular third molar surgery.

4°C sterile saline solution

4°C 0.2% chlorhexidine solution PROCEDURE

Patients whose extraction sockets will be irrigated with 4°C 0.2% chlorhexidine solution following mandibular third molar surgery.

4°C 0.2% chlorhexidine solution

25°C 0.2% chlorhexidine solution PROCEDURE

Patients whose extraction sockets will be irrigated with 25°C 0.2% chlorhexidine solution following mandibular third molar surgery.

25°C 0.2% chlorhexidine solution

4°C 1.5% hydrogen peroxide solution PROCEDURE

Patients whose extraction sockets will be irrigated with 4°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.

4°C 1.5% hydrogen peroxide solution

25°C 1.5% hydrogen peroxide solution PROCEDURE

Patients whose extraction sockets will be irrigated with 25°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.

25°C 1.5% hydrogen peroxide solution

25°C sterile saline solution PROCEDURE

Patients whose extraction sockets will be irrigated with 25°C sterile saline solution following mandibular third molar surgery.

25°C sterile saline solution

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences, Keciören, Ankara

Ankara, 06610, Turkey (Türkiye)

Location

Related Publications (4)

• Sifuentes-Cervantes JS, Carrillo-Morales F, Castro-Nunez J, Cunningham LL, Van Sickels JE. Third molar surgery: Past, present, and the future. Oral Surg Oral Med Oral Pathol Oral Radiol. 2021 Nov;132(5):523-531. doi: 10.1016/j.oooo.2021.03.004. Epub 2021 Mar 14.

  PMID: 34030996 BACKGROUND

• Canakci FG, Er N, Duygu G, Tanan Karaca G. Does Saline Irrigation at Different Temperatures Affect Pain, Edema, and Trismus After Impacted Third Molar Surgery: A Clinical Trial. J Oral Maxillofac Surg. 2023 Jan;81(1):88-94. doi: 10.1016/j.joms.2022.08.015. Epub 2022 Aug 29.

  PMID: 36116545 BACKGROUND

• Shahraki M, Khazaei AH, Hakimi S, Hasheminasab M, Haradasht SA. Effect of chlorhexidine, povidone-iodine, and hydrogen peroxide irrigation on pain and swelling after mandibular third molar surgery: randomized controlled trial. Int J Oral Maxillofac Surg. 2025 Jul;54(7):677-683. doi: 10.1016/j.ijom.2025.01.021. Epub 2025 Feb 14.

  PMID: 39952838 BACKGROUND

• Brauer HU. Unusual complications associated with third molar surgery: a systematic review. Quintessence Int. 2009 Jul-Aug;40(7):565-72.

  PMID: 19626231 BACKGROUND

Central Study Contacts

Sara Samur Ergüven, DDS, PhD. Associate Professor

CONTACT

5334165005; sara.samur@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Group 1: Patients whose extraction sockets will be irrigated with 4°C sterile saline solution following mandibular third molar surgery. Group 2: Patients whose extraction sockets will be irrigated with 25°C sterile saline solution following mandibular third molar surgery. Group 3: Patients whose extraction sockets will be irrigated with 4°C 0.2% chlorhexidine solution following mandibular third molar surgery. Group 4: Patients whose extraction sockets will be irrigated with 25°C 0.2% chlorhexidine solution following mandibular third molar surgery. Group 5: Patients whose extraction sockets will be irrigated with 4°C 1.5% hydrogen peroxide solution following mandibular third molar surgery. Group 6: Patients whose extraction sockets will be irrigated with 25°C 1.5% hydrogen peroxide solution following mandibular third molar surgery. In the present study all patients will be systemically healthy individuals classified as ASA Physical Status I, between 18 and 35 years.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

TU (1)