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Clinical Trials/NCT06020053
NCT06020053CompletedNot Applicable

Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars

Firat University2 sites in 1 country18 target enrollmentStarted: March 2, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
18
Locations
2
Primary Endpoint
Pain was noted on the 2nd, 4th, and 7th days.

Study Overview

Brief Summary

An Evaluation of the Effect of Using Irrigations at Different Temperatures on Pain, Edema, and Trismus During the Extraction of Bilateral Impacted Mandibular Third Molars: A Randomized Split-Mouth Clinical Trial

Detailed Description

Abstract Introduction: The surgical extraction of impacted wisdom teeth is a standard practice in dentistry. Unfortunately, inflammatory reactions such as discomfort, edema, and trismus frequently jeopardize patients' well-being after the extraction of third molars. Saline solutions at room temperature (25°C) are routinely used in impacted tooth extraction. Refrigerated serums were used to work with cold serum, and since the refrigerator temperature was 4°C, this study was designed to have a cold serum temperature of 4°C. This study aims to assess the influence of saline irrigation at various temperatures (4°C, 25°C) on postoperative edema, pain, and trismus after the extraction of impacted third molars.

Materials and Methods

Eighteen patients with bilateral symmetrical mandibular impacted third molars were enrolled in this split-mouth, randomized, prospective, double-blind clinical trial. For each patient, one side was irrigated with a solution at 4°C (test), and the other side was irrigated with a solution at room temperature (25°C) (control). Pain, trismus, and facial edema were noted on the 2nd, 4th, and 7th days. A Mann-Whitney U-test was used to compare pairs, and a Wilcoxon signed-rank test was used to compare groups.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients aged 18 to 30 who were classified as ASA (American Society of Anesthesiologists)1 and who required the removal of impacted third molars on either the right or left side of the mandible;
  • Presence of impacted mandibular third molars on panoramic radiographs, bilaterally symmetrical, with bone retention and bone removal for extraction, position B class 2 of impacted teeth according to the Pell and Gregory Classification System, and mesioangular position according to the Winter Classification;
  • Absence of systemic disease and habitual smoking behavior and absence of an allergy to the drugs to be used postoperatively.

Exclusion Criteria

  • Patients with a history of taking antibiotics and analgesics for at least one month;
  • Having an infection in the operation area and acute pericoronitis or severe periodontal disease before the operation;
  • The existence of cysts and tumors within proximity of the impacted third molar.

Outcomes

Primary Outcomes

Pain was noted on the 2nd, 4th, and 7th days.

Time Frame: on the 2nd, 4th, and 7th days.

Pain was evaluated with a 10-unit visual analog scale (VAS), which was included in the patient follow-up form on the postoperative second, fourth, and seventh days.

Secondary Outcomes

  • trismus was noted on the 2nd, 4th, and 7th days.(on the 2nd, 4th, and 7th days.)
  • facial edema was noted on the 2nd, 4th, and 7th days(on the 2nd, 4th, and 7th days.)

Investigators

Sponsor
Firat University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ceren Dayanan

research assistant

Firat University

Study Sites (2)

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