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.
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
- Conditions the study is for
- Impacted Mandibular Third Molar Extraction
- 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.
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 group | Role | What they receive |
|---|---|---|
| Kinesio Tape | Experimental | Not described Receives: Other: Kinesio Tape application |
| Dexamethasone | Active comparator | Not described Receives: Drug: Intramuscular Injection of Dexamethasone |
| Control | Active comparator | Not described Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Lateral corner of the eye to angle of the mandible
- Tragus to corner of the mouth
- 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
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
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.
- First posted20 Jan 2026
- Study start1 Oct 2023
- Primary completion30 Sep 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third Molar ExtractionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ashraf elanzy
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Sponsor-investigator, Ashraf elanzy, Mansoura University
- Investigators
- Mohamed Abdelmonem Tawfik, Prof, Principal investigator, Mansoura UniversityFakhreldin Hassan Abdelrahman, PHD, Principal investigator, Mansoura University
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio Tape Versus Systemic Dexamethasone on Postsurgical Sequels Following Extraction of Impacted Mandibular Third Molars
- ClinicalTrials.gov ID
- NCT07353593
- Acronym / sponsor ID
- M0208023os
- Keywords
- Kinesio Tape, Dexamethasone, Mandibular Third Molar, Oral Surgery, Postoperative Edema, Pain Management, Trismus, Non-Pharmacological Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ashraf elanzyUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 20 Jan 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesio Tape | Experimental | Other: Kinesio Tape application |
| Dexamethasone | Active comparator | Drug: Intramuscular Injection of Dexamethasone |
| Control | Active comparator | Other: control |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Uncooperative patients.
- Smoker patients.
- Pregnant or lactating women.
- Women taking oral contraceptives.
- Patient with systemic diseases.
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 Tape applicationKinesio Tape application after horizontal impacted mandibular third molar extraction | Other | Kinesio Tape |
| Intramuscular Injection of Dexamethasone8 M.g Intramuscular Injection of Dexamethasone** after horizontal impacted mandibular third molar extraction | Drug | Dexamethasone |
| controlleft to heal without use of Dexamethasone nor Kinesio Tape after horizontal impacted mandibular third molar extraction | Other | Control |
Primary outcome
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
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.
Maximum interincisal distance (mm) to assess mouth opening after mandibular third molar extraction
Time frame: Immediately after extraction, Day 3, and Day 7 postoperatively
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.
Pain intensity score after mandibular third molar extraction measured using the Visual Analog Scale (VAS, 1-10)
Time frame: Immediately after extraction, Day 3, and Day 7 postoperatively
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.
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 20 Jan 2026.
- Individual participant dataSharing planned: 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.
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Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
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Comparison of PRF and Corticosteroids in Impacted Third Molar Surgery
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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.
Mohamed Abdelmonem Tawfik, Prof principal investigator
Mansoura University
Fakhreldin Hassan Abdelrahman, PHD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
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.