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CTRI Number  CTRI/2025/06/089366 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 20/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Physiotherapy (Not Including YOGA)
Other (Specify) [Post operative care]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on kinesio tape for reducing pain and swelling after wisdom tooth surgery. 
Scientific Title of Study   Impact of kinesio tape application on post-operative recovery in patients undergoing surgical extraction of impacted mandibular third molars a randomized clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakshi S Mishra 
Designation  Post graduate 
Affiliation  Meenakshi Academy of Higher Education and research 
Address  Room no 5, Department of Oral and maxillofacial surgery, Meenakshi Ammal Dental College and Hospital

Chennai
TAMIL NADU
600095
India 
Phone  9730370202  
Fax    
Email  sakshim2099@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepanjali M 
Designation  Associate Professor, Co guide 
Affiliation  Meenakshi Academy of Higher Education and research 
Address  Room no 5, Department of Oral and maxillofacial surgery, Meenakshi Ammal Dental College and Hospital

Chennai
TAMIL NADU
600095
India 
Phone  9159111996  
Fax    
Email  drdeepanjali.da@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sakshi S Mishra 
Designation  Post graduate 
Affiliation  Meenakshi Academy of Higher Education and research 
Address  Room no 5, Department of oral and maxillofacial surgery, Meenakshi Ammal Dental College and Hospital

Chennai
TAMIL NADU
600095
India 
Phone  9730370202  
Fax    
Email  sakshim2099@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Sakshi Mishra 
Address  Meenkashi Ammal dental college and hospital, Alapakkam main road, maduravoyal, chennai-600095, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakshi S Mishra  Meenakshi Ammal Dental college and hospital chennai  On campus Department of Oral and maxillofacial surgery Meenakshi Ammal Dental college and hospital chennai Maduravoyal 600095
Chennai
TAMIL NADU 		 9730370202

sakshim2099@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committtee Meenakshi Ammal Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kinesio Taping  Kinesio Taping involves applying a special elastic tape on the skin over the cheek and jaw area after surgery for 7 days. The tape is applied in a specific pattern to help reduce swelling, improve blood and lymph flow, and support faster healing. It stays on the skin for a few days and is painless to apply and remove. 
Comparator Agent  Standard post-operative care (analgesics, antibiotics, cold compress, and routine instructions)  Patients in the comparator group will receive the usual post-surgical care after wisdom tooth removal. This includes medications for pain relief, antibiotics if prescribed, cold compresses, and general instructions for diet and oral hygiene to be followed for 5-7 days. No Kinesio Tape will be applied in this group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  South Indian patients aged 18-60 years.
Scheduled for surgical extraction of impacted
mandibular third molars.
Asymptomatic patients without any general
diseases.
Patients willing to participate in the study and
provide informed consent. 
 
ExclusionCriteria 
Details  Contraindications to surgical extraction of
impacted mandibular third molars.
History of allergies to adhesive tapes or
components of Kinesio Tape.
Pregnant or lactating women.
Patients unable to provide informed consent or
participate in follow-up assessment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
-Pain levels assessed using Visual Analog Scale (VAS).
-Swelling measured using standardized techniques. (tape measure)
-Trismus evaluated by measuring inter-incisal opening.
-Quality of life assessed using validated questionnaires (modified UW-QoL v4) 		 Preoperative, day 1, day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sakshim2099@gmail.com].

  6. For how long will this data be available start date provided 20-08-2025 and end date provided 20-08-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This randomized clinical trial aims to evaluate the effect of Kinesio Taping on post-operative recovery following surgical removal of impacted mandibular third molars. Patients undergoing lower wisdom tooth extraction will be randomly allocated into two groups: one receiving elastic therapeutic taping (Kinesio Tape) over the jaw area, and the other receiving standard post-operative care. The study will compare outcomes such as swelling, pain, and mouth opening during the recovery period to assess whether Kinesio Taping improves healing and reduces post-operative complications.

 
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