Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07006610

Hilotherapy vs. Kinesio Taping in Orthognathic Surgery Recovery

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Mega Hospital

Istanbul, Bağcılar, 34214, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gamze Senol Kılıc, Assistant Professor

PRINCIPAL_INVESTIGATOR

Merve Gaye Akgok, PhD Student

CONTACT

[email protected]

+905064571329

Ozge Sen, PhD Student

CONTACT

[email protected]

+905392179460

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesio Tex® Gold Taping

Device

Elastic kinesio tape applied postoperatively to the facial region and left in place for 5 days.

Hilotherm® Facial Cooling System

Device

A polyurethane facial mask delivering continuous +17°C water cooling for 48 hours post-surgery.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ozge Sen, PhD Student

CONTACT

[email protected]

+905392179460

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.