Hilotherapy vs. Kinesio Taping in Orthognathic Surgery Recovery

NCT07006610 | Recruiting

• 2 other identifiers: MEDIPOL-BAP-2024-39BAP-2024-39
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Edema; Postoperative Pain; Trismus; Orthognathic Surgery

Keywords

Hilotherapy; Kinesio Taping; Orthognathic Surgery; Postoperative Complications; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• Change in Facial Edema

  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 Outcomes (2)

• Change in Pain Score (VAS)

  Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30 |

• Change in Trismus (Maximum Mouth Opening)

  Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30

Study Arms (2)

Hilotherapy Group

EXPERIMENTAL

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

Kinesio Taping Group

EXPERIMENTAL

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

Interventions

Kinesio Tex® Gold Taping DEVICE

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

Kinesio Taping Group

Hilotherm® Facial Cooling System DEVICE

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

Hilotherapy Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Presence of systemic disease or immunosuppressive medication
• Known allergy to kinesio tape
• Inability to attend follow-up appointments
• Facial anatomical deformities preventing measurement

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Mega Hospital

Istanbul, Bağcılar, 34214, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Trismus; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Central Study Contacts

Ozge Sen, PhD Student

CONTACT

+905392179460; ozge.sen@std.medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: September 15, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)