Clinical trial NCT07006610: Hilotherapy vs. Kinesio Taping in Orthognathic Surgery Recovery
Official title: Comparison of the Effects of Hilotherapy and Kinesio Taping on Edema, Pain, and Trismus After Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Edema
Postoperative Pain
Trismus
Orthognathic Surgery
Keywords: Hilotherapy
Kinesio Taping
Orthognathic Surgery
Postoperative Complications
Postoperative Recovery
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Facial Edema
timeFrame: Baseline (Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30
Secondary outcomes:
measure: Change in Pain Score (VAS)
timeFrame: Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30 |
measure: Change in Trismus (Maximum Mouth Opening)
timeFrame: Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Mega Hospital
state: Bağcılar
Study officials:
References:
citation: Rana M, Gellrich NC, Joos U, Piffko J, Kater W. 3D evaluation of postoperative swelling using two different cooling methods following orthognathic surgery: a randomised observer blind prospective pilot study. Int J Oral Maxillofac Surg. 2011 Jul;40(7):690-6. doi: 10.1016/j.ijom.2011.02.015. Epub 2011 Mar 15.
citation: Tozzi U, Santagata M, Sellitto A, Tartaro GP. Influence of Kinesiologic Tape on Post-operative Swelling After Orthognathic Surgery. J Maxillofac Oral Surg. 2016 Mar;15(1):52-8. doi: 10.1007/s12663-015-0787-0. Epub 2015 Mar 29.
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citation: Golkar M, Taheri A, Alam M, Asadi Y, Keyhan SO. The effects of Kinesio tapes on facial swelling following bimaxillary orthognathic surgery in the supraclavicular region. Maxillofac Plast Reconstr Surg. 2023 Jun 19;45(1):22. doi: 10.1186/s40902-023-00385-7.