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

NCT ID: NCT06020053

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-02

Study Completion Date

2022-06-09

Brief Summary

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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

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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.

Conditions

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Impacted Third Molar Tooth

Keywords

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irrigation, third molar surgery, temperature,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

saline irrigation at various temperatures (4°C, 25°C)

Intervention Type PROCEDURE

cold serum application

Interventions

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saline irrigation at various temperatures (4°C, 25°C)

cold serum application

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Firat University

OTHER

Sponsor Role lead

Responsible Party

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Ceren Dayanan

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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muhammet ozupek

Role: STUDY_DIRECTOR

Firat University

Locations

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Fırat Üniversitesi

Merkez, Elaziğ, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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FiratUniversitydentistry

Identifier Type: -

Identifier Source: org_study_id