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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorSaglik Bilimleri Universitesi

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 4°C sterile saline solution

    Procedure/Surgery

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

  • 25°C sterile saline solution

    Procedure/Surgery

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

  • 4°C 0.2% chlorhexidine solution

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

78 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: 4°C sterile saline solutionExperimental treatment 1 intervention
Group B: 25°C sterile saline solutionExperimental treatment 1 intervention
Group C: 4°C 0.2% chlorhexidine solutionExperimental treatment 1 intervention
Group D: 25°C 0.2% chlorhexidine solutionExperimental treatment 1 intervention
Group E: 4°C 1.5% hydrogen peroxide solutionExperimental treatment 1 intervention
Group F: 25°C 1.5% hydrogen peroxide solutionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Edema (Swelling)

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

Time frame
Preoperatively and on postoperative days 2, 4, and 7
2

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.

Time frame
Preoperative and postoperative days 2, 4, and 7 using a 10-cm VAS.
3

Trismus (Restriction of Mouth Opening)

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

Time frame
Preoperative day and postoperative days 2, 4, and 7

Secondary outcomes

1

Oral Health Related Quality of Life (QoL)

The Oral Health Impact Profile-14 (OHIP-14), a validated and reliable instrument, will be used to evaluate changes in patients' daily comfort and oral health-related quality of life.

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

Other outcomes

Sponsors and contacts

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