An interventional study of Kinesio Tex® Gold Taping and Hilotherm® Facial Cooling System in Postoperative Edema, Postoperative Pain and Trismus, sponsored by Medipol University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Medipol University · Not applicable, Interventional, and Treatment
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 36 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Elastic kinesio tape applied postoperatively to the facial region and left in place for 5 days.
A polyurethane facial mask delivering continuous +17°C water cooling for 48 hours post-surgery.
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.
Time frame: Baseline (Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30
Change in Pain Score (VAS)
Pain will be assessed using a 10-point Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating the worst imaginable pain.
Time frame: Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30 |
Change in Trismus (Maximum Mouth Opening)
Trismus will be assessed by measuring maximum interincisal distance using a millimeter ruler.
Time frame: Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30
Plan to share: No — Individual participant data (IPD) will not be shared because the study is a single-center academic thesis project with a limited sample size and no data-sharing agreement is planned.
Started Sep 2024 (actual). Primary completion is estimated for Jul 2025, 10 months after the start.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 10 months is close to that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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