NCT07833540

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1.6 years

First QC Date

September 16, 2026

Last Update Submit

September 16, 2026

Conditions

Keywords

Kinesio TapingCompression TapingBimaxillary Orthognathic Surgery

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Preoperative baseline, immediately postoperative, and postoperative days 2, 5, and 7

Secondary Outcomes (1)

  • Oral Health-Related Quality of Life

    Preoperative baseline, and postoperative weeks 1 and 3

Study Arms (2)

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.

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.

Other: Rigid Compression Taping

Interventions

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.

Kinesio Taping Group

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.

Rigid Compression Taping Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Receiving regular medication Diagnosed mental disorder Coagulopathy Diabetes mellitus Chronic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University, Faculty of Dentistry

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeEdema

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gamze Cobanoglu, Asst. Prof.

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to visible differences between elastic Kinesio tape and rigid compression tape, participants, the treating physiotherapist, and the outcome assessor could not be blinded to group allocation. The surgical team remained unaware of group allocation during the surgical procedure because the interventions were applied only after surgery was completed
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 22, 2026

Study Start

December 1, 2024

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations