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

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
saline irrigation at various temperatures (4°C, 25°C)
Sponsored by
Firat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Impacted Third Molar Tooth focused on measuring irrigation,, third molar surgery,, temperature,

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fırat Üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

One of the symmetrical Impacted Mandibular Third Molars, control group

One of the symmetrical Impacted Mandibular Third Molars, intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

trismus was noted 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.
facial edema was noted 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.

Full Information

First Posted
July 20, 2023
Last Updated
August 27, 2023
Sponsor
Firat University
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1. Study Identification

Unique Protocol Identification Number
NCT06020053
Brief Title
Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars
Official Title
Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Firat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
irrigation,, third molar surgery,, temperature,

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One of the symmetrical Impacted Mandibular Third Molars, control group
Arm Type
No Intervention
Arm Description
Serum at room temperature (25°C) was applied to one of the mandibular impacted third molars
Arm Title
One of the symmetrical Impacted Mandibular Third Molars, intervention group
Arm Type
Experimental
Arm Description
Serum at temperature (4°C) was applied to one of the mandibular impacted third molars
Intervention Type
Procedure
Intervention Name(s)
saline irrigation at various temperatures (4°C, 25°C)
Intervention Description
cold serum application
Primary Outcome Measure Information:
Title
Pain was noted on the 2nd, 4th, and 7th days.
Description
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.
Time Frame
on the 2nd, 4th, and 7th days.
Secondary Outcome Measure Information:
Title
trismus was noted on the 2nd, 4th, and 7th days.
Description
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.
Time Frame
on the 2nd, 4th, and 7th days.
Title
facial edema was noted on the 2nd, 4th, and 7th days
Description
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.
Time Frame
on the 2nd, 4th, and 7th days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
muhammet ozupek
Organizational Affiliation
Firat University
Official's Role
Study Director
Facility Information:
Facility Name
Fırat Üniversitesi
City
Merkez
State/Province
Elaziğ
ZIP/Postal Code
23200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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