- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07370870
Is Cryotherapy Beneficial After Surgical Removal of Impacted Lower Third Molars?
January 20, 2026 updated by: Henrique Tedesco
Is Cryotherapy Beneficial After Surgical Removal of Impacted Lower Third Molars? - A Randomized Split Mouth Clinical Trial
The present study aimed to investigate the effects of cryotherapy on postoperative parameters (pain intensity, edema, trismus, and the quality of life) after lower third molar extraction.
Patients underwent bilateral extraction of mandibular third molars in a single surgical procedure.
Cryotherapy was applied to one side using facial ice packs, while no cryotherapy was performed on the contralateral side.
Surgical procedures, postoperative instructions, and prescribed medications were identical for both sides.
Consequently, the side treated with ice packs exhibited lower pain intensity, shorter pain duration, and reduced use of rescue medication.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- Indication for bilateral surgical removal of mandibular third molars in similar positions
- Absence of systemic comorbidities
- Absence of local inflammatory processes
- Absence of local infectious processes
- No history of allergy to the prescribed medications
- No chronic use of antibiotics, anti-inflammatory drugs, corticosteroids, and/or analgesics
Exclusion Criteria
- Use of medications other than those prescribed by the surgeon
- Failure to provide the required data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group A
Patients in whom postoperative cryotherapy was not applied
|
|
|
Experimental: Group B
Patients in whom postoperative cryotherapy was applied
|
Postoperative cold therapy applied with ice packs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of cryotherapy on postoperative pain intensity after lower third molar extraction - using a visual analog scale.
Time Frame: 7 days
|
Evaluate the effects of cryotherapy on postoperative pain intensity following lower third molar extraction using a visual analog scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable.
Pain intensity was recorded daily by the participants over a 7-day postoperative period.
|
7 days
|
|
Evaluate the effects of cryotherapy on postoperative edema after lower third molar extraction - using the mean of three linear facial measurements
Time Frame: 7 days
|
Evaluate the effects of cryotherapy on postoperative edema following lower third molar extraction using three linear facial measurements: tragus to pogonion, tragus to oral commissure, and lateral canthus to the mandibular angle.
Measurements were recorded in millimeters, and the mean of the three values was calculated to quantify edema.
Assessments were performed preoperatively and postoperatively on the second and seventh days.
|
7 days
|
|
Evaluate the effects of cryotherapy on postoperative trismus after lower third molar extraction - measuring maximum mouth opening
Time Frame: 7 days
|
Evaluate the effects of cryotherapy on postoperative trismus following lower third molar extraction by measuring maximum mouth opening.
Patients were seated with the tragus-ala plane parallel to the ground.
Measurements were obtained using a measuring tape and recorded in millimeters.
Assessments were performed on postoperative days 0, 2, and 7.
|
7 days
|
|
Evaluate the effects of cryotherapy on postoperative quality of life after lower third molar extraction - using a questionnaire adapted from the Oral Health Impact Profile-14 (OHIP-14)
Time Frame: 7 days
|
Evaluate the effects of cryotherapy on postoperative quality of life following lower third molar extraction using a questionnaire adapted from the Oral Health Impact Profile-14 (OHIP-14), consisting of 14 dichotomous (yes/no) questions addressing daily functional limitations.
The questionnaire was administered on the day of surgery and completed by participants on postoperative days 0, 2, and 7.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2017
Primary Completion (Actual)
July 30, 2017
Study Completion (Actual)
December 20, 2017
Study Registration Dates
First Submitted
January 2, 2026
First Submitted That Met QC Criteria
January 20, 2026
First Posted (Actual)
January 27, 2026
Study Record Updates
Last Update Posted (Actual)
January 27, 2026
Last Update Submitted That Met QC Criteria
January 20, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 75651517.4.0000.5347 (Other Identifier: Universidade Federal do Rio Grande do Sul)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.