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Impacted Mandibular Third Molar ExtractionPhase 1NCT07353593

Effect of Kinesio Tape Versus Systemic Dexamethasone on Postsurgical Sequels Following Extraction of Impacted Mandibular Third Molars

A Phase 1 study testing Kinesio Tape application and Intramuscular Injection of Dexamethasone in people with Impacted Mandibular Third Molar Extraction, run by Ashraf elanzy at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The surgical removal of lower wisdom teeth is a common procedure that can cause pain, facial swelling, and difficulty in opening the mouth after surgery. These symptoms are usually managed with medications such as dexamethasone, which helps reduce inflammation but may have unwanted side effects in some patients. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
What is being tested?
Kinesio Tape application and Intramuscular Injection of Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Oct 2023to 30 Apr 2025
Phase
Phase 1
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 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients (male and female) with age 20-40 years old.
  • Co-operative patients.
  • An impacted lower wisdom tooth diagnosed with a moderate to severe difficulty index according to Pell and Gregory or Pederson scale classification.104
  • Medically Free from any systemic conditions.

Who cannot join

  • Uncooperative patients.
  • Smoker patients.
  • Pregnant or lactating women.
  • Women taking oral contraceptives.
  • Patient with systemic diseases.
  • Patients misunderstanding the clinical procedures of the study.
Show all 10Show fewer
  • Individuals allergic or intolerant to Dexamethasone used in the study.
  • Patients on oral anticoagulants.
  • Uncontrolled diabetic patients.
  • Individuals with periodontal disease or active infection at the site of impacted tooth.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mansura Universtiy

    Al Mansurah, Mansura, 14323

Other trials in Egypt

About this study

The surgical removal of lower wisdom teeth is a common procedure that can cause pain, facial swelling, and difficulty in opening the mouth after surgery. These symptoms are usually managed with medications such as dexamethasone, which helps reduce inflammation but may have unwanted side effects in some patients.

This study compares the use of dexamethasone with Kinesio Tape, a non-drug treatment applied to the skin, to evaluate their effectiveness in reducing pain, swelling, and limited mouth opening after wisdom tooth removal. The findings of this study may help determine whether Kinesio Tape can be a safe and effective alternative to medication for improving recovery after surgery.

Read the detailed description

The extraction of impacted mandibular third molars is one of the most common procedures performed in oral and maxillofacial surgery. Despite being a routine intervention, it is frequently associated with significant postoperative complications, including pain, edema, and trismus, all of which negatively impact patient recovery and quality of life. These sequelae result from the inflammatory response induced by surgical trauma, leading to increased vascular permeability, extracellular fluid accumulation, and the release of inflammatory mediators. Given these concerns, optimizing postoperative management strategies is critical to improving patient outcomes and enhancing recovery. Traditional pharmacological interventions, particularly dexamethasone, have been widely employed due to their potent anti-inflammatory effects. However, concerns regarding systemic side effects, contraindications, and long-term implications have led to increasing interest in non-pharmacological alternatives such as Kinesio Tape (KT).

The physiological response following third molar extraction is driven by a complex interplay of cellular and molecular mechanisms aimed at tissue healing and immune regulation. Surgical trauma triggers the activation of pro-inflammatory cytokines, including tumor necrosis factor-alpha, interleukin-1 beta, and interleukin-6, which contribute to increased vascular permeability, edema formation, and nociceptor sensitization. This inflammatory cascade ultimately results in pain, swelling, and limited mouth opening due to spasm and fibrosis of the masticatory muscles, particularly the masseter and pterygoid muscles. The peak of these complications typically occurs within 48 hours postoperatively and, if not adequately managed, may lead to prolonged recovery, reduced oral function, and impaired patient satisfaction.

Dexamethasone is a long-acting glucocorticoid that exerts its effects by inhibiting the transcription of pro-inflammatory genes, thereby reducing cytokine release, stabilizing cell membranes, and preventing fluid extravasation into surrounding tissues. Evidence has shown that a single preoperative dose of dexamethasone administered via submucosal or intramuscular injection can effectively reduce postoperative swelling, trismus, and pain intensity, making it a widely adopted intervention in oral surgery. Nevertheless, despite its efficacy, systemic corticosteroids are associated with potential risks, including immunosuppression, delayed wound healing, alterations in glucose metabolism, and adrenal suppression with prolonged use. These concerns have necessitated the exploration of alternative strategies capable of achieving comparable anti-inflammatory effects without systemic exposure.

Kinesio Tape has gained increasing attention in rehabilitation medicine and sports therapy, with growing interest in its role in postoperative recovery. Designed to lift the skin, decompress underlying tissues, and enhance lymphatic drainage, KT has been proposed as an effective method for reducing edema, improving blood circulation, and modulating neuromuscular function. Unlike corticosteroids, which act at the molecular level to suppress inflammation, KT exerts its effects mechanically by redistributing interstitial pressure, facilitating fluid dynamics, and promoting natural healing mechanisms.

Clinical investigations have assessed the efficacy of KT in reducing postoperative complications following third molar extraction. Application of KT has been associated with reductions in swelling, pain intensity, and trismus during the early postoperative period, suggesting a sustained benefit in controlling tissue inflammation. Moreover, KT does not induce systemic effects, making it an attractive option for patients with contraindications to corticosteroid therapy.

Comparative evaluations between dexamethasone and KT in managing postoperative sequelae suggest that while dexamethasone provides a more immediate reduction in inflammation, KT offers a gradual and sustained improvement in edema resolution. KT application has also been associated with improved patient-reported comfort, potentially due to its continuous therapeutic effect throughout the postoperative period, in contrast to the transient pharmacological action of corticosteroids.

Despite promising findings regarding KT as an alternative or adjunct to dexamethasone, gaps remain in understanding its optimal clinical application, efficacy across diverse patient populations, and potential synergistic effects when combined with pharmacological interventions. This study aims to address these gaps by conducting a comprehensive comparative analysis of Kinesio Tape versus dexamethasone in mitigating postoperative pain, swelling, and trismus following mandibular third molar extraction. Through this investigation, the study seeks to contribute meaningful insights into the development of multimodal, minimally invasive postoperative management strategies in oral surgery.

Being tested
Kinesio Tape application, Intramuscular Injection of Dexamethasone, control
Keywords
Kinesio Tape, Dexamethasone, Mandibular Third Molar, Oral Surgery, Postoperative Edema, Pain Management, Trismus, Non-Pharmacological Therapy
Medical subject headings
Agnosia, Trismus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinesio Tape applicationOther

    Kinesio Tape application after horizontal impacted mandibular third molar extraction

  • Intramuscular Injection of DexamethasoneDrug

    8 M.g Intramuscular Injection of Dexamethasone** after horizontal impacted mandibular third molar extraction

  • controlOther

    left to heal without use of Dexamethasone nor Kinesio Tape after horizontal impacted mandibular third molar extraction

Study groups in NCT07353593
Study groupRoleWhat they receive
Kinesio TapeExperimentalNot described
Receives: Other: Kinesio Tape application
DexamethasoneActive comparatorNot described
Receives: Drug: Intramuscular Injection of Dexamethasone
ControlActive comparatorNot described
Receives: Other: control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Facial swelling (edema) measured in millimeters at three facial points after mandibular third molar extraction

    Edema will be assessed using a flexible ruler at three standardized points:

    1. Lateral corner of the eye to angle of the mandible
    2. Tragus to corner of the mouth
    3. Inferior point of the angle of the mandible to lateral point of the lip commissure Measurements will be performed immediately after extraction, at 3 days, and at 7 days postoperatively.

    Measured: Immediately after extraction, Day 3, and Day 7 postoperatively

  2. Maximum interincisal distance (mm) to assess mouth opening after mandibular third molar extraction

    Mouth opening will be measured as the maximum interincisal distance using a caliper. Measurements will be taken immediately after extraction, at 3 days, and at 7 days postoperatively.

    Measured: Immediately after extraction, Day 3, and Day 7 postoperatively

  3. Pain intensity score after mandibular third molar extraction measured using the Visual Analog Scale (VAS, 1-10)

    Pain intensity will be self-reported by each participant using the Visual Analog Scale (VAS) ranging from 1 (no pain) to 10 (worst pain imaginable). Pain will be assessed immediately post-extraction, at 3 days, and at 7 days postoperatively.

    Measured: Immediately after extraction, Day 3, and Day 7 postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start1 Oct 2023
  3. Primary completion30 Sep 2024
  4. Study completion30 Apr 2025

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07353593
Sponsor's protocol ID
M0208023os
Status last verified
Dec 2025
First submitted
24 Dec 2025
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study will not share individual participant data (IPD) outside the primary research group due to the small sample size and to protect participant confidentiality.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Kinesio Tape application and Intramuscular Injection of Dexamethasone in people with Impacted Mandibular Third Molar Extraction, run by Ashraf elanzy at 1 site in Egypt.

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 10 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 20 Jan 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 Egypt. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Facial swelling (edema) measured in millimeters at three facial points after mandibular third molar extraction (time frame: Immediately after extraction, Day 3, and Day 7 postoperatively). The study lists 3 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 20 Jan 2026.

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