Cold TherapyNCT07370870
Is Cryotherapy Beneficial After Surgical Removal of Impacted Lower Third Molars?
A study testing Cold Therapy in people with Cold Therapy, run by Henrique Tedesco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold Therapy
- What is being tested?
- Cold Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Use of medications other than those prescribed by the surgeon
- Failure to provide the required data
About this study
Official title: 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.
- Conditions
- Cold Therapy
- Being tested
- Cold Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold TherapyOther
Postoperative cold therapy applied with ice packs
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Patients in whom postoperative cryotherapy was not applied |
| Group B | Experimental | Patients in whom postoperative cryotherapy was applied Receives: Other: Cold Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start15 Jan 2017
- Primary completion30 Jul 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized split-mouth clinical trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrique Tedesco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrique Tedesco, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370870
- Sponsor's protocol ID
- 75651517.4.0000.5347
- Other IDs
- 75651517.4.0000.5347
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Cryotherapy Beneficial After Surgical Removal of Impacted Lower Third Molars? - A Randomized Split Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07370870
- Acronym / sponsor ID
- 75651517.4.0000.5347
- Conditions
- Cold Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Henrique TedescoUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized split-mouth clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Patients in whom postoperative cryotherapy was not applied |
| Group B | Experimental | Other: Cold TherapyPatients in whom postoperative cryotherapy was applied |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Use of medications other than those prescribed by the surgeon
- Failure to provide the required data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold TherapyPostoperative cold therapy applied with ice packs | Other | Group B |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Therapy in people with Cold Therapy, run by Henrique Tedesco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of cryotherapy on postoperative pain intensity after lower third molar extraction - using a visual analog scale. (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.