Postoperative EdemaNCT07006610
Hilotherapy vs. Kinesio Taping in Orthognathic Surgery Recovery
A study testing Kinesio Tex® Gold Taping and Hilotherm® Facial Cooling System in people with Postoperative Edema and Postoperative Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Postoperative Edema, Postoperative Pain, Trismus
- What is being tested?
- Kinesio Tex® Gold Taping and Hilotherm® Facial Cooling System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Presence of systemic disease or immunosuppressive medication
- Known allergy to kinesio tape
- Inability to attend follow-up appointments
- Facial anatomical deformities preventing measurement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University Mega Hospital
Istanbul, Bağcılar, 34214
Ozge Sen, PhD Student, +905392179460, ozge.sen@std.medipol.edu.tr
Merve Gaye Akgok, PhD Student, +905064571329, merve.akgok@std.medipol.edu.tr
About this study
Official title: Comparison of the Effects of Hilotherapy and Kinesio Taping on Edema, Pain, and Trismus After Orthognathic Surgery
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.
Read the 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.
- Conditions
- Postoperative Edema, Postoperative Pain, Trismus, Orthognathic Surgery
- Being tested
- Kinesio Tex® Gold Taping, Hilotherm® Facial Cooling System
- Keywords
- Hilotherapy, Kinesio Taping, Orthognathic Surgery, Postoperative Complications, Postoperative Recovery
- Medical subject headings
- Pain, Postoperative, Trismus, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio Tex® Gold TapingDevice
Elastic kinesio tape applied postoperatively to the facial region and left in place for 5 days.
Hilotherm® Facial Cooling SystemDevice
A polyurethane facial mask delivering continuous +17°C water cooling for 48 hours post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Kinesio Tex® Gold Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline(Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start15 Sep 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative EdemaStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Sen, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006610
- Sponsor's protocol ID
- MEDIPOL-BAP-2024-39
- Other IDs
- BAP-2024-39
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 21411291Tozzi 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.
PubMed 26929553Apostolov 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.
PubMed 28280702Wei 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.
PubMed 22019891Golkar 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.
PubMed 37335425
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Hilotherapy and Kinesio Taping on Edema, Pain, and Trismus After Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT07006610
- Acronym / sponsor ID
- MEDIPOL-BAP-2024-39
- Conditions
- Postoperative Edema, Postoperative Pain, Trismus, Orthognathic Surgery
- Keywords
- Hilotherapy, Kinesio Taping, Orthognathic Surgery, Postoperative Complications, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hilotherapy Group | Experimental | Device: Hilotherm® Facial Cooling SystemParticipants 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. |
| Kinesio Taping Group | Experimental | Device: Kinesio Tex® Gold TapingParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of systemic disease or immunosuppressive medication
- Known allergy to kinesio tape
- Inability to attend follow-up appointments
- Facial anatomical deformities preventing measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio Tex® Gold TapingElastic kinesio tape applied postoperatively to the facial region and left in place for 5 days. | Device | Kinesio Taping Group |
| Hilotherm® Facial Cooling SystemA polyurethane facial mask delivering continuous +17°C water cooling for 48 hours post-surgery. | Device | Hilotherapy Group |
Primary outcome
Change in Facial Edema
Time frame: Baseline (Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 21411291Rana 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.
- Background: PubMed 26929553Tozzi 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.
- Background: PubMed 28280702Apostolov 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.
- Background: PubMed 22019891Wei 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.
- Background: PubMed 37335425Golkar 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Tex® Gold Taping and Hilotherm® Facial Cooling System in people with Postoperative Edema and Postoperative Pain, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ozge Sen, PhD Student (+905392179460, ozge.sen@std.medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Facial Edema (time frame: Baseline (Post-op 1.hour) and Post-op Days 1, 2, 5, 10, and 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07006610, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.