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Recruiting NCT07006610

Hilotherapy vs. Kinesio Taping in Orthognathic Surgery Recovery

No phase Interventional Postoperative Edema Postoperative Pain Trismus Orthognathic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kinesio Tex® Gold Taping, Hilotherm® Facial Cooling System.
Who it may be relevant to
Registry conditions: Postoperative Edema, Postoperative Pain, Trismus, Orthognathic Surgery. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Kinesio Tex® Gold Taping
    Elastic kinesio tape applied postoperatively to the facial region and left in place for 5 days.
  • Device Hilotherm® Facial Cooling System
    A polyurethane facial mask delivering continuous +17°C water cooling for 48 hours post-surgery.

Primary outcome measures

  • Change in Facial Edema [Time frame: Baseline (Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30]
Secondary outcome measures (2)
  • Change in Pain Score (VAS) [Time frame: 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Medipol University Mega Hospital — Istanbul

Publications

  • 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. PMID 21411291
  • 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. PMID 26929553
  • Apostolov R, Asadi K, Lokan J, Kam N, Testro A. Mycophenolate mofetil toxicity mimicking acute cellular rejection in a small intestinal transplant. World J Transplant. 2017 Feb 24;7(1):98-102. doi: 10.5500/wjt.v7.i1.98. PMID 28280702
  • Wei W, Zhao H, Wang A, Sui M, Liang K, Deng H, Ma Y, Zhang Y, Zhang H, Guan Y. A clinical study on the short-term effect of berberine in comparison to metformin on the metabolic characteristics of women with polycystic ovary syndrome. Eur J Endocrinol. 2012 Jan;166(1):99-105. doi: 10.1530/EJE-11-0616. Epub 2011 Oct 21. PMID 22019891
  • 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. PMID 37335425

Identifiers

NCT: NCT07006610 · MEDIPOL-BAP-2024-39 · BAP-2024-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗