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

Sponsor
Firat University (Other)
Overall Status
Completed
CT.gov ID
NCT06020053
Collaborator
(none)
18
1
2
15.2
1.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: saline irrigation at various temperatures (4°C, 25°C)
N/A

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
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars
Actual Study Start Date :
Mar 2, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 9, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: One of the symmetrical Impacted Mandibular Third Molars, control group

Serum at room temperature (25°C) was applied to one of the mandibular impacted third molars

Experimental: One of the symmetrical Impacted Mandibular Third Molars, intervention group

Serum at temperature (4°C) was applied to one of the mandibular impacted third molars

Procedure: saline irrigation at various temperatures (4°C, 25°C)
cold serum application

Outcome Measures

Primary Outcome Measures

  1. Pain was noted on the 2nd, 4th, and 7th days. [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 Outcome Measures

  1. trismus was noted on the 2nd, 4th, and 7th days. [on the 2nd, 4th, and 7th days.]

    For trismus, preoperative and postoperative mouth openings were evaluated on the second, fourth, and seventh days by measuring the maximum distance between the incisal surface of the right maxillary incisor and the incisal surface of the right mandibular incisor with a caliper.

  2. facial edema was noted on the 2nd, 4th, and 7th days [on the 2nd, 4th, and 7th days.]

    The level of facial edema was evaluated using Amin Laskin's protocol. Two measurements between four reference points were taken using a tape measure to assess facial edema. The distance between the tragus and the lip commissure and between the gonion and the lateral (outer) canthus of the eye were measured with a tape measure preoperatively and on the second, fourth, and seventh days after the operation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fırat Üniversitesi Merkez Elaziğ Turkey 23200

Sponsors and Collaborators

  • Firat University

Investigators

  • Study Director: muhammet ozupek, Firat University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ceren Dayanan, research assistant, Firat University
ClinicalTrials.gov Identifier:
NCT06020053
Other Study ID Numbers:
  • FiratUniversitydentistry
First Posted:
Aug 31, 2023
Last Update Posted:
Aug 31, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ceren Dayanan, research assistant, Firat University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 31, 2023