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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

36

Phase

  • 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 Locations

  • Turkey
    • Bağcılar
      • Istanbul, Bağcılar, Turkey, 34214
        • Recruiting
        • Istanbul 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

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
Intervention / Treatment
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

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

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

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)

September 15, 2024

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

May 27, 2025

First Submitted That Met QC Criteria

May 27, 2025

First Posted (Estimated)

June 5, 2025

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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