Orthognathic SurgeryNCT07833540
Kinesio Taping vs Rigid Compression Taping Following Bimaxillary Orthognathic Surgery
A study testing Kinesio Taping and Rigid Compression Taping in people with Orthognathic Surgery and Postoperative Pain, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative facial swelling and pain are common complications following corrective jaw surgery (bimaxillary orthognathic surgery). This randomized controlled trial aimed to determine whether elastic therapeutic taping (Kinesio taping) applied using a mechanical correction technique is more effective than standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthognathic Surgery, Postoperative Pain, Edema
- What is being tested?
- Kinesio Taping and Rigid Compression Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years Scheduled to undergo elective bimaxillary orthognathic surgery consisting of Le Fort I maxillary osteotomy and bilateral sagittal split osteotomy of the mandible Provided written informed consent
Who cannot join
- Receiving regular medication Diagnosed mental disorder Coagulopathy Diabetes mellitus Chronic infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Faculty of Dentistry
Ankara, Ankara, 06560
About this study
Official title: Management of Pain and Facial Edema Following Bimaxillary Orthognathic Surgery: Kinesio Taping Versus Rigid Compression Taping: Randomized Controlled Trial
Postoperative facial swelling and pain are common complications following corrective jaw surgery (bimaxillary orthognathic surgery). This randomized controlled trial aimed to determine whether elastic therapeutic taping (Kinesio taping) applied using a mechanical correction technique is more effective than standard rigid compression taping in reducing acute postoperative pain and facial swelling. The study also evaluated changes in oral health-related quality of life.
A total of 36 adult patients undergoing elective bimaxillary orthognathic surgery were randomly assigned into two equal groups (18 participants per group):
Read more
Kinesio Taping Group: Participants received bilateral elastic Kinesio taping applied with a mechanical correction technique.
Rigid Compression Taping Group: Participants received bilateral rigid compression taping over the surgical facial area.
Both taping applications were initiated immediately following surgery and maintained for 7 days, with tape replacement on the third postoperative day. All participants received identical standardized postoperative medication and cryotherapy protocols. Pain intensity was measured using a Visual Analog Scale (VAS) across 7 days, facial swelling was assessed through bilateral landmark tape measurements across 7 days, and quality of life was evaluated using the Orthognathic Quality of Life Questionnaire (OQLQ) through 3 weeks post-surgery.
Read the detailed description
This prospective, two-arm, parallel-group randomized controlled trial was conducted at Ankara University Faculty of Dentistry following ethical approval from Gazi University.
Participants scheduled for elective bimaxillary orthognathic surgery-consisting of Le Fort I maxillary osteotomy and bilateral sagittal split osteotomy (BSSO) of the mandible-were allocated in a 1:1 ratio using a computer-generated simple randomization sequence.
Standardized Perioperative Care:
All participants underwent standardized bimaxillary surgery under general anesthesia. Postoperatively, all patients received a uniform medication regimen including amoxicillin/clavulanic acid (or alternative if allergic), chlorhexidine mouthwash, routine paracetamol, weight-based methylprednisolone tapering, rescue analgesia (dexketoprofen trometamol as needed), a decongestant preparation, and gastric protection. In addition, standardized intermittent bilateral cryotherapy (5 minutes on, 5 minutes off) was administered during the first 24 hours.
Intervention Protocols:
Kinesio Taping Group: 5-cm wide Kinesio tape was applied bilaterally over the postoperative facial region using the mechanical correction technique with 75%-100% tension in the correction zone and no tension at the anchors.
Rigid Compression Taping Group: Bilateral non-elastic rigid tape was applied firmly over the postoperative facial area to provide mechanical compression without neurovascular or airway restriction.
Both interventions were applied immediately post-surgery by a trained physiotherapist, renewed on postoperative day 3, and removed on day 7.
Assessments and Follow-up:
Pain: Assessed via a 100-mm Visual Analog Scale (VAS) at postoperative hours 6, 12, 24 (day 1), and days 2, 3, and 7. Cumulative early pain (hours 6-24) and total pain scores were also analyzed.
Facial Edema: Quantified using bilateral flexible plastic tape measurements across seven standardized anatomical facial distances (tragus-labial commissure, tragus-pogonion, tragus-lateral canthus, gonion-lateral canthus, gonion-nasion, gonion-pogonion, and tragus-nasal alar crest) measured preoperatively, immediately post-surgery, and on postoperative days 2, 5, and 7.
Quality of Life: Measured using the 22-item Orthognathic Quality of Life Questionnaire (OQLQ) administered preoperatively and at postoperative weeks 1 and 3.
- Conditions
- Orthognathic Surgery, Postoperative Pain, Edema
- Being tested
- Kinesio Taping, Rigid Compression Taping
- Keywords
- Kinesio Taping, Compression Taping, Bimaxillary Orthognathic Surgery
- Medical subject headings
- Pain, Postoperative, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingOther
Bilateral facial application of 5-cm wide elastic Kinesio tape using the mechanical correction technique with 75%-100% tension in the correction area and no tension at the anchors. Applied immediately after bimaxillary orthognathic surgery, renewed on postoperative day 3, and maintained for 7 days alongside standardized postoperative medication and cryotherapy protocols.
Rigid Compression TapingOther
Bilateral non-elastic rigid compression taping applied firmly over the postoperative facial region to provide mechanical compression and support without impairing circulation or respiration. Applied immediately after bimaxillary orthognathic surgery, renewed on postoperative day 3, and maintained for 7 days alongside standardized postoperative medication and cryotherapy protocols.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping Group | Experimental | Participants received bilateral facial Kinesio taping (standard width 5 cm) applied using the mechanical correction technique with 75%-100% tension in the correction zone. Taping was applied immediately after orthognathic surgery, renewed on postoperative day 3, and maintained for 7 days alongside standardized postoperative medication and cryotherapy protocols. Receives: Other: Kinesio Taping |
| Rigid Compression Taping Group | Active comparator | Participants received bilateral rigid compression taping applied firmly over the postoperative facial region to provide mechanical compression and support. Taping was applied immediately after orthognathic surgery, renewed on postoperative day 3, and maintained for 7 days alongside standardized postoperative medication and cryotherapy protocols. Receives: Other: Rigid Compression Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Pain intensity was evaluated using a 100-mm Visual Analog Scale (VAS), where 0 represents "no pain" and 100 represents "the worst imaginable pain" (higher scores indicate greater pain intensity). Evaluated at 6, 12, 24 hours and days 2, 3, and 7 post-surgery.
Measured: Postoperative hours 6, 12, 24, and postoperative days 2, 3, and 7
Facial Edema
Facial edema was quantified using a flexible millimeter tape across seven standardized bilateral linear facial reference distances: tragus-labial commissure, tragus-pogonion, tragus-lateral canthus, gonion-lateral canthus, gonion-nasion, gonion-pogonion, and tragus-nasal alar crest (measured in millimeters; increases reflect greater facial edema). Evaluated preoperatively, immediately after surgery, and on days 2, 5, and 7 post-surgery.
Measured: Preoperative baseline, immediately postoperative, and postoperative days 2, 5, and 7
Secondary outcomes (1)
Oral Health-Related Quality of Life
Assessed using the 22-item Orthognathic Quality of Life Questionnaire (OQLQ), evaluating four domains: facial aesthetics, oral function, awareness of dentofacial aesthetics, and social aspects of dentofacial deformity. Each item is scored on a 4-point scale (total score ranges from 0 to 88, where higher scores indicate greater impairment or poorer quality of life). Evaluated preoperatively and at postoperative weeks 1 and 3.
Measured: Preoperative baseline, and postoperative weeks 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Dec 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Model description
- Participants undergoing bimaxillary orthognathic surgery were allocated in a 1:1 ratio to receive either bilateral Kinesio taping or rigid compression taping. Both taping applications were maintained for 7 days alongside standardized postoperative medical therapy and cryotherapy
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, Gamze COBANOGLU, Gazi University
- Investigators
- Gamze Cobanoglu, Asst. Prof., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833540
- Sponsor's protocol ID
- 2024-295
- Other IDs
- TSG-2024-3459
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pain and Facial Edema Following Bimaxillary Orthognathic Surgery: Kinesio Taping Versus Rigid Compression Taping: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07833540
- Acronym / sponsor ID
- 2024-295
- Conditions
- Orthognathic Surgery, Postoperative Pain, Edema
- Keywords
- Kinesio Taping, Compression Taping, Bimaxillary Orthognathic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 Sep 2026 (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.
Postoperative facial swelling and pain are common complications following corrective jaw surgery (bimaxillary orthognathic surgery). This randomized controlled trial aimed to determine whether elastic therapeutic taping (Kinesio taping) applied using a mechanical correction technique is more effective than standard rigid compression taping in reducing acute postoperative pain and facial swelling. The study also evaluated changes in oral health-related quality of life.
A total of 36 adult patients undergoing elective bimaxillary orthognathic surgery were randomly assigned into two equal groups (18 participants per group):
Kinesio Taping Group: Participants received bilateral elastic Kinesio taping applied with a mechanical correction technique.
Rigid Compression Taping Group: Participants received bilateral rigid compression taping over the surgical facial area.
Both taping applications were initiated immediately following surgery and maintained for 7 days, with tape replacement on the third postoperative day. All participants received identical standardized postoperative medication and cryotherapy protocols. Pain intensity was measured using a Visual Analog Scale (VAS) across 7 days, facial swelling was assessed through bilateral landmark tape measurements across 7 days, and quality of life was evaluated using the Orthognathic Quality of Life Questionnaire (OQLQ) through 3 weeks post-surgery.
Detailed description
This prospective, two-arm, parallel-group randomized controlled trial was conducted at Ankara University Faculty of Dentistry following ethical approval from Gazi University.
Participants scheduled for elective bimaxillary orthognathic surgery-consisting of Le Fort I maxillary osteotomy and bilateral sagittal split osteotomy (BSSO) of the mandible-were allocated in a 1:1 ratio using a computer-generated simple randomization sequence.
Standardized Perioperative Care:
All participants underwent standardized bimaxillary surgery under general anesthesia. Postoperatively, all patients received a uniform medication regimen including amoxicillin/clavulanic acid (or alternative if allergic), chlorhexidine mouthwash, routine paracetamol, weight-based methylprednisolone tapering, rescue analgesia (dexketoprofen trometamol as needed), a decongestant preparation, and gastric protection. In addition, standardized intermittent bilateral cryotherapy (5 minutes on, 5 minutes off) was administered during the first 24 hours.
Intervention Protocols:
Kinesio Taping Group: 5-cm wide Kinesio tape was applied bilaterally over the postoperative facial region using the mechanical correction technique with 75%-100% tension in the correction zone and no tension at the anchors.
Rigid Compression Taping Group: Bilateral non-elastic rigid tape was applied firmly over the postoperative facial area to provide mechanical compression without neurovascular or airway restriction.
Both interventions were applied immediately post-surgery by a trained physiotherapist, renewed on postoperative day 3, and removed on day 7.
Assessments and Follow-up:
Pain: Assessed via a 100-mm Visual Analog Scale (VAS) at postoperative hours 6, 12, 24 (day 1), and days 2, 3, and 7. Cumulative early pain (hours 6-24) and total pain scores were also analyzed.
Facial Edema: Quantified using bilateral flexible plastic tape measurements across seven standardized anatomical facial distances (tragus-labial commissure, tragus-pogonion, tragus-lateral canthus, gonion-lateral canthus, gonion-nasion, gonion-pogonion, and tragus-nasal alar crest) measured preoperatively, immediately post-surgery, and on postoperative days 2, 5, and 7.
Quality of Life: Measured using the 22-item Orthognathic Quality of Life Questionnaire (OQLQ) administered preoperatively and at postoperative weeks 1 and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants undergoing bimaxillary orthognathic surgery were allocated in a 1:1 ratio to receive either bilateral Kinesio taping or rigid compression taping. Both taping applications were maintained for 7 days alongside standardized postoperative medical therapy and cryotherapy
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping Group | Experimental | Other: Kinesio TapingParticipants received bilateral facial Kinesio taping (standard width 5 cm) applied using the mechanical correction technique with 75%-100% tension in the correction zone. Taping was applied immediately after orthognathic surgery, renewed on postoperative day 3, and maintained for 7 days alongside standardized postoperative medication and cryotherapy protocols. |
| Rigid Compression Taping Group | Active comparator | Other: Rigid Compression TapingParticipants received bilateral rigid compression taping applied firmly over the postoperative facial region to provide mechanical compression and support. Taping was applied immediately after orthognathic surgery, renewed on postoperative day 3, and maintained for 7 days alongside standardized postoperative medication and cryotherapy protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age older than 18 years Scheduled to undergo elective bimaxillary orthognathic surgery consisting of Le Fort I maxillary osteotomy and bilateral sagittal split osteotomy of the mandible Provided written informed consent
Key exclusion criteria (1 listed)
- Receiving regular medication Diagnosed mental disorder Coagulopathy Diabetes mellitus Chronic infection
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 TapingBilateral facial application of 5-cm wide elastic Kinesio tape using the mechanical correction technique with 75%-100% tension in the correction area and no tension at the anchors. Applied immediately after bimaxillary orthognathic surgery, renewed on postoperative day 3, and maintained for 7 days alongside standardized postoperative medication and cryotherapy protocols. | Other | Kinesio Taping Group |
| Rigid Compression TapingBilateral non-elastic rigid compression taping applied firmly over the postoperative facial region to provide mechanical compression and support without impairing circulation or respiration. Applied immediately after bimaxillary orthognathic surgery, renewed on postoperative day 3, and maintained for 7 days alongside standardized postoperative medication and cryotherapy protocols. | Other | Rigid Compression Taping Group |
Primary outcome
Postoperative Pain Intensity
Time frame: Postoperative hours 6, 12, 24, and postoperative days 2, 3, and 7
Pain intensity was evaluated using a 100-mm Visual Analog Scale (VAS), where 0 represents "no pain" and 100 represents "the worst imaginable pain" (higher scores indicate greater pain intensity). Evaluated at 6, 12, 24 hours and days 2, 3, and 7 post-surgery.
Facial Edema
Time frame: Preoperative baseline, immediately postoperative, and postoperative days 2, 5, and 7
Facial edema was quantified using a flexible millimeter tape across seven standardized bilateral linear facial reference distances: tragus-labial commissure, tragus-pogonion, tragus-lateral canthus, gonion-lateral canthus, gonion-nasion, gonion-pogonion, and tragus-nasal alar crest (measured in millimeters; increases reflect greater facial edema). Evaluated preoperatively, immediately after surgery, and on days 2, 5, and 7 post-surgery.
1 secondary outcome
Oral Health-Related Quality of Life
Time frame: Preoperative baseline, and postoperative weeks 1 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gamze Cobanoglu, Asst. Prof. principal investigator
Gazi University
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 Taping and Rigid Compression Taping in people with Orthognathic Surgery and Postoperative Pain, run by Gazi 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: Postoperative hours 6, 12, 24, and postoperative days 2, 3, and 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.