- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07333963
Adjunctive Kinesiotaping in Surgical Treatment of Impacted Mandibular Third Molars
Application of Kinesiotaping as an Adjunctive Physiotherapeutic Method in the Surgical Management of Impacted Mandibular Third Molars
PATIENT INFORMATION SHEET Participants are invited to take part in a clinical study involving surgical removal of an impacted lower wisdom tooth. Participation in this study is entirely voluntary.
The purpose of this study is to observe the healing process after wisdom tooth removal and to assess whether the use of elastic therapeutic tape placed on the skin (kinesiotaping) may support recovery.
SURGICAL PROCEDURE The procedure will be performed under local anesthesia and will include: - Administration of local anesthesia
- Incision of the gum
- Exposure of the impacted tooth and surrounding bone
- Removal of the tooth
- Cleaning of the surgical site - Placement of sutures After the surgery, standard post■operative instructions will be provided. STUDY PROCEDURE
After the surgical procedure, patients will be randomly assigned to one of two groups:
- Standard post■operative care
- Post■operative care combined with application of elastic therapeutic tape on the skin of the face and neck area If the participants are assigned to the tape group, the tape will be applied immediately after surgery by qualified medical personnel and will remain in place for several days.
FOLLOW■UP VISITS Participant will be asked to attend follow■up visits on specific days after the procedure to allow the medical team to assess healing. PAIN MANAGEMENT Participant will be allowed to take pain medication if necessary, following medical advice.
VOLUNTARY PARTICIPATION Participation in this study is voluntary. Participant may withdraw from the study at any time without giving a reason and without affecting participants medical care.
CONFIDENTIALITY All medical information collected during the study will be handled confidentially and used solely for research purposes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Silesian Voivodeship
-
Bytom, Silesian Voivodeship, Poland, 41-902
- Uniwersyteckie centrum stomatologii
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- No systemic diseases (generally healthy patient)
Indication for surgical extraction of impacted lower third molars for:
orthodontic reasons
surgical reasons
prophylactic reasons
Age between 16 and 64 years
Written informed consent to participate in the study
Exclusion Criteria:
- Presence of chronic systemic diseases, including:
diabetes mellitus
hypertension
autoimmune diseases
Pharmacological treatment in the period preceding the surgery
Pregnancy
Substance abuse or dependence
Head and neck malignancies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Research group
Group undergoing Kinesiotaping after the surgical procedure
|
basic lymphatic KT application
basic surgical extraction
|
|
Other: Control Group
no kinesiotaping
|
basic surgical extraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain intensity
Time Frame: 2 days post-surgery and 7 days post-surgery
|
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate greater pain intensity.
|
2 days post-surgery and 7 days post-surgery
|
|
Maximum Mouth Opening (MMO)
Time Frame: FinishBefore surgery, 2 days after surgery, and 7 days after surgery
|
Maximum mouth opening will be measured using a caliper as the interincisal distance between the upper and lower incisors at maximum mouth opening.
|
FinishBefore surgery, 2 days after surgery, and 7 days after surgery
|
|
Facial Soft Tissue Swelling
Time Frame: Before surgery, 2 days after surgery, and 7 days after surgery
|
Facial swelling will be assessed using linear tape measurements between six predefined facial reference points.
The sum of distances will be used for analysis.
|
Before surgery, 2 days after surgery, and 7 days after surgery
|
|
Postoperative Analgesic Consumption
Time Frame: Day of surgery, 2 days after surgery, and 7 days after surgery
|
The total number of ketoprofen 100 mg tablets taken by each participant will be recorded as a measure of postoperative analgesic demand.
|
Day of surgery, 2 days after surgery, and 7 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNW/NWN/0052/KB1/57/I/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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