Hilotherapy vs. Kinesio Taping in Orthognathic Surgery Recovery

Medipol University

Status: Enrolling

Conditions: Postoperative Pain; Trismus; Postoperative Edema; Orthognathic Surgery

Treatments: Device: Hilotherm® Facial Cooling System; Device: Kinesio Tex® Gold Taping

Study type: Interventional

Funder types: Other

Identifiers

NCT07006610

BAP-2024-39 (Other Grant/Funding Number)

MEDIPOL-BAP-2024-39

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Hilotherapy Group

Experimental group

Description:

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.

Treatment:

Device: Hilotherm® Facial Cooling System

Kinesio Taping Group

Experimental group

Description:

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.

Treatment:

Device: Kinesio Tex® Gold Taping