3D evaluation of postoperative swelling using two different cooling methods following orthognathic surgery: a randomised observer blind prospective pilot study.
M Rana, N C Gellrich, U Joos...
https://pubmed.ncbi.nlm.nih.gov/21411291Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
All Genders
ID07006610
Comparison of Hilotherapy and Kinesio Taping Effects on Edema, Pain, and Trismus After Orthognathic Surgery
Led by Medipol University · Updated on 2025-06-05
36
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research aims to compare the effects of kinesio taping and hilotherapy on reducing swelling, pain, and limited mouth opening after bimaxillary orthognathic surgery. The study involves patients aged 18 to 50 years without systemic diseases undergoing Le Fort I and BSSRO surgeries. Researchers seek to find which method better supports recovery after these operations. Participants will be randomly assigned to one of two groups. One group will wear a Hilotherm® facial cooling mask delivering water at +17°C continuously for 48 hours, starting one hour after surgery and worn at least 16 hours daily. The other group will have Kinesio Tex® Gold tape applied to the face one hour after surgery, kept in place for 5 days without removal. Both treatments aim to reduce postoperative complications. Throughout the study, facial swelling will be measured using tape and 3D scanning at several points up to 30 days after surgery. Pain levels and mouth opening ability will also be assessed at these times. Participants will attend follow-up visits to monitor recovery and safety. The total observation period lasts 30 days post-surgery to evaluate the outcomes of each therapy.
CONDITIONS
Brief Title
Hilotherapy vs. Kinesio Taping in Orthognathic Surgery Recovery
Who Can Participate
Age: 18Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Presence of systemic disease or immunosuppressive medication
- Known allergy to kinesio tape
- Inability to attend follow-up appointments
- Facial anatomical deformities preventing measurement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - 48 hours to 5 days
Participants undergo orthognathic surgery followed by immediate post-operative care including application of hilotherapy or kinesio taping.
1 surgery visit; hilotherapy worn for 48 hours; kinesio taping worn for 5 days
Post-operative Follow-up
Duration - Up to 30 days post-surgery
Participants are assessed for pain, facial edema, and trismus at multiple time points after surgery to monitor recovery.
Visits at post-op 1 hour, and on days 1, 2, 5, 10, and 30
Trial Site Locations
Total: 1 location
1
Istanbul Medipol University Mega Hospital
Istanbul, Bağcılar, Turkey (Türkiye), 34214
Actively Recruiting
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Research Team
O
Ozge Sen, PhD Student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Influence of Kinesiologic Tape on Post-operative Swelling After Orthognathic Surgery.
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https://pubmed.ncbi.nlm.nih.gov/22019891The effects of Kinesio tapes on facial swelling following bimaxillary orthognathic surgery in the supraclavicular region.
Mohsen Golkar, Anita Taheri, Mostafa Alam...
https://pubmed.ncbi.nlm.nih.gov/37335425