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

NCT06020053 | Completed

• 1 other identifier: FiratUniversitydentistry
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Impacted Third Molar Tooth

Keywords

irrigation,; third molar surgery,; temperature,

Outcome Measures

Primary Outcomes (1)

• Pain was noted 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.

  on the 2nd, 4th, and 7th days.

Secondary Outcomes (2)

• 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.

Study Arms (2)

One of the symmetrical Impacted Mandibular Third Molars, control group

NO INTERVENTION

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

One of the symmetrical Impacted Mandibular Third Molars, intervention group

EXPERIMENTAL

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)

Interventions

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

cold serum application

One of the symmetrical Impacted Mandibular Third Molars, intervention group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat Üniversitesi

Merkez, Elaziğ, 23200, Turkey (Türkiye)

Location

Study Officials

• muhammet ozupek

  Firat University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 31, 2023
• Study Start: March 2, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 9, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)