NCT07764731

Brief Summary

The goal of this prospective clinical trial is to evaluate the additive therapeutic efficacy of Kinesio taping combined with routine post-surgical cryotherapy in reducing acute postoperative facial edema and pain in adult patients undergoing bimaxillary orthognathic surgery. The main questions it aims to answer are: Does the application of compression Kinesio taping significantly reduce post-surgical facial edema compared to standard postoperative care alone? Does Kinesio taping provide additional pain relief and functional recovery during the early acute postoperative phase when compared with standard compression taping? Researchers will compare patients receiving bilateral Kinesio taping alongside standard postoperative cryotherapy to a control group receiving standard postoperative cryotherapy alongside standard compression taping to see if Kinesio taping taping provides a superior or additive effect in decreasing edema and alleviating pain. Participants will: Undergo bimaxillary orthognathic surgery under a standardized surgical protocol. Receive routine postoperative cold/cryotherapy application as part of baseline care. Randomly, have Kinesio tape applied immediately postoperatively using a compression taping approach (intervention group) or receive standard rigid compression taping (control group). Undergo standardized facial swelling and pain assessments at pre-determined postoperative follow-up intervals.

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 Jun 2024

Typical duration for not_applicable

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

June 3, 2024

Completed
2.1 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
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

2.1 years

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Facial edema

    Edema evaluation was performed using a standard flexible plastic tape measure (accuracy ±0.5 mm). Seven linear facial distances were recorded bilaterally and the sum of both sides was used for analysis.

    Immediately after surgery and post-op day 2

  • Postoperative pain

    Postoperative pain intensity was assessed using a 100-mm visual analog scale (VAS). The scale was anchored by "no pain" at one end and "the worst pain imaginable" at the other. Participants were instructed to mark the point on the line that best represented their current level of postoperative pain. The distance between the "no pain" anchor and the participant's mark was measured and converted to a score ranging from 0 to 100, with higher scores indicating greater pain intensity.

    Immediately after surgery and post-op day 2

  • Facial edema

    Edema evaluation was performed using a standard flexible plastic tape measure (accuracy ±0.5 mm). Seven linear facial distances were recorded bilaterally and the sum of both sides was used for analysis.

    Post-op day 2 and post-op day 5

  • Postoperative pain

    Postoperative pain intensity was assessed using a 100-mm visual analog scale (VAS). The scale was anchored by "no pain" at one end and "the worst pain imaginable" at the other. Participants were instructed to mark the point on the line that best represented their current level of postoperative pain. The distance between the "no pain" anchor and the participant's mark was measured and converted to a score ranging from 0 to 100, with higher scores indicating greater pain intensity.

    Post-op day 2 and post-op day 5

  • Facial edema

    Edema evaluation was performed using a standard flexible plastic tape measure (accuracy ±0.5 mm). Seven linear facial distances were recorded bilaterally and the sum of both sides was used for analysis.

    Post-op day 5 and post-op day 7

  • Postoperative pain

    Postoperative pain intensity was assessed using a 100-mm visual analog scale (VAS). The scale was anchored by "no pain" at one end and "the worst pain imaginable" at the other. Participants were instructed to mark the point on the line that best represented their current level of postoperative pain. The distance between the "no pain" anchor and the participant's mark was measured and converted to a score ranging from 0 to 100, with higher scores indicating greater pain intensity.

    Post-op day 5 and post-op day 7

Secondary Outcomes (3)

  • Oral health-related quality of life

    Immediately after surgery and post-op day 2

  • Oral health-related quality of life

    Post-op day 2 and post-op day 5

  • Oral health-related quality of life

    Post-op day 5 and post-op day 7

Study Arms (2)

Kinesio tape

EXPERIMENTAL

Participants in this arm received bilateral facial Kinesio taping using standard 5-cm wide elastic tape in addition to routine postoperative care. The tape was applied immediately following surgery using the mechanical correction technique with a tension of approximately 75%-100% across the correction area, while the anchors were placed with no tension (0%). The tape strips followed anatomical landmarks along the postoperative facial region. On the third postoperative day, the initial tape was removed, the skin was inspected for potential adverse reactions (e.g., redness, irritation, itching, or blistering), and a new set of tape strips were applied following the same protocol. The Kinesio taping was maintained for a total duration of seven consecutive days.

Other: Kinesio tape

Rigid compression taping

ACTIVE COMPARATOR

Participants in this arm received bilateral rigid compression taping over the postoperative facial region immediately following surgery. The tape strips followed the same anatomical landmarks along the postoperative facial region. The tape tension was adjusted manually by a trained physiotherapist to provide firm compression and support while avoiding excessive pressure, circulatory impairment, respiratory restriction, or marked discomfort. The rigid compression tape was replaced on the third postoperative day, and the facial skin was inspected for potential adverse reactions such as redness, irritation, or pressure marks. The rigid compression taping was maintained for a total treatment duration of seven days.

Other: Rigid compression taping

Interventions

Participants allocated to the kinesiotaping group received bilateral facial taping using kinesiotaping with a standard width of 5 cm.

Kinesio tape

Participants allocated to the comparison group received bilateral rigid compression taping over the postoperative facial region.

Rigid compression taping

Eligibility Criteria

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

You may qualify if:

  • Individuals older than 18 years of age.
  • Patients scheduled to undergo elective bimaxillary orthognathic surgery

You may not qualify if:

  • Individuals receiving regular medication.
  • Individuals with a diagnosed mental disorder.
  • Individuals with coagulopathy.
  • Individuals with diabetes mellitus.
  • Individuals with a chronic infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University, Faculty of Dentistry

Ankara, Cankaya, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAgnosia

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc Prof.

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start

June 3, 2024

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

The datasets generated and/or analyzed during the present study are not publicly available due to ethical restrictions and patient privacy regulations set by the institutional ethics committee. However, anonymized data may be made available from the corresponding author upon reasonable request.

Locations