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| ID | Type | Description | Link |
|---|---|---|---|
| BAP-2024-39 | Other Grant/Funding Number | Istanbul Medipol University Scientific Research Projects Commission (BAP) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinesio Tex® Gold Taping | Device | Elastic kinesio tape applied postoperatively to the facial region and left in place for 5 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30 | |
| Change in Trismus (Maximum Mouth Opening) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ozge Sen, PhD Student | Contact | +905392179460 | ozge.sen@std.medipol.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University Mega Hospital | Recruiting | Istanbul | Bağcılar | 34214 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21411291 | Background | 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. | |
| 26929553 | Background |
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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.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D014313 | Trismus |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| Hilotherm® Facial Cooling System | Device | A polyurethane facial mask delivering continuous +17°C water cooling for 48 hours post-surgery. |
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Trismus will be assessed by measuring maximum interincisal distance using a millimeter ruler. |
| Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30 |
| 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. |
| 28280702 | 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. |
| 22019891 | 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. |
| 37335425 | 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. |
| D012816 | Signs and Symptoms |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |