Hilotherapy vs. Kinesio Taping in Orthognathic Surgery Recovery

May 27, 2025 updated by: Ozge Sen, Medipol University

Comparison of the Effects of Hilotherapy and Kinesio Taping on Edema, Pain, and Trismus After Orthognathic Surgery

This prospective randomized controlled trial aims to compare the effects of kinesio taping and hilotherapy on postoperative edema, pain, and trismus in patients undergoing bimaxillary orthognathic surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Orthognathic surgery frequently causes postoperative edema, pain, and trismus. The study compares two adjunctive therapies: kinesio taping and hilotherapy. Forty-four patients without systemic disease, undergoing Le Fort I + BSSRO, will be randomly assigned to two groups. Group 1 will receive kinesio taping for 5 days. Group 2 will undergo hilotherapy for 48 hours. Pain (VAS), trismus (mouth opening), and edema (measured by both tape and 3D scanner) will be assessed at multiple postoperative time points. The goal is to determine the more effective intervention for postoperative recovery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Bağcılar
      • Istanbul, Bağcılar, Turkey, 34214
        • Recruiting
        • İstanbul Medipol University Mega Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gamze Senol Kılıc, Assistant Professor

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients scheduled to undergo bimaxillary orthognathic surgery (Le Fort I + BSSRO)
  • Age between 18 and 50 years
  • No systemic disease
  • Voluntary participation with signed informed consent

Exclusion Criteria:

  • Presence of systemic disease or immunosuppressive medication
  • Known allergy to kinesio tape
  • Inability to attend follow-up appointments
  • Facial anatomical deformities preventing measurement

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hilotherapy Group
Participants in this group will receive hilotherapy applied one hour after orthognathic surgery. A polyurethane facial mask (Hilotherm® device) delivering continuously cooled water at +17°C will be worn for at least 16 hours per day, for a total of 48 hours. The therapy aims to reduce postoperative pain, edema, and trismus through controlled cooling.
Device: Hilotherm® Facial Cooling System
A polyurethane facial mask delivering continuous +17°C water cooling for 48 hours post-surgery.
Experimental: Kinesio Taping Group
Participants in this group will receive kinesio taping applied one hour after orthognathic surgery. The tapes (Kinesio Tex® Gold) will remain in place for 5 days (120 hours) without removal. The taping is intended to promote lymphatic drainage, reduce facial swelling, and improve functional recovery.
Device: Kinesio Tex® Gold Taping
Elastic kinesio tape applied postoperatively to the facial region and left in place for 5 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Facial Edema
Time Frame: Baseline (Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30
Facial edema will be measured using both linear tape-based anthropometric measurements and 3D facial scanning at specified time points. Measurements will include tragus-to-ala, tragus-to-pogonion, and other standard facial distances.
Baseline (Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pain Score (VAS)
Time Frame: Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30 |
Pain will be assessed using a 10-point Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating the worst imaginable pain.
Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30 |
Change in Trismus (Maximum Mouth Opening)
Time Frame: Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30
Trismus will be assessed by measuring maximum interincisal distance using a millimeter ruler.
Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEDIPOL-BAP-2024-39
  • BAP-2024-39 (Other Grant/Funding Number: Istanbul Medipol University Scientific Research Projects Commission (BAP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the study is a single-center academic thesis project with a limited sample size and no data-sharing agreement is planned.

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.

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