NCT07370870

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 2, 2026

Last Update Submit

January 20, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Effects of cryotherapy on postoperative pain intensity after lower third molar extraction - using a visual analog scale.

    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

    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

    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)

    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

Study Arms (2)

Group A

NO INTERVENTION

Patients in whom postoperative cryotherapy was not applied

Group B

EXPERIMENTAL

Patients in whom postoperative cryotherapy was applied

Other: Cold Therapy

Interventions

Postoperative cold therapy applied with ice packs

Group B

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Use of medications other than those prescribed by the surgeon
  • Failure to provide the required data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized split-mouth clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 27, 2026

Study Start

January 15, 2017

Primary Completion

July 30, 2017

Study Completion

December 20, 2017

Last Updated

January 27, 2026

Record last verified: 2026-01