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CTRI Number  CTRI/2021/05/033359 [Registered on: 04/05/2021] Trial Registered Prospectively
Last Modified On: 02/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessing use of Kinesiologic Tape for post operative complications after surgically removing lower wisdom tooth. 
Scientific Title of Study   Comparative assessment of post operative sequelae following surgical removal of mandibular third molar with and without extra-oral application of kinesiologic tape. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sneha Patil 
Designation  PG trainee 
Affiliation  Datta Meghe Institute of Medical Sciences (Deemed to be University) 
Address  OPD no. 4 Department of Oral and Maxillofacial Surgery Sharad Pawar Dental College Datta Meghe Institute of Medical Sciences (Deemed to be University) Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  8818991447  
Fax    
Email  docsneha.patil07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajanikanth 
Designation  MDS, Ph.D, Professor 
Affiliation  Datta Meghe Institute of Medical Sciences (Deemed to be University) 
Address  OPD no. 4 Department of Oral and Maxillofacial Surgery Sharad Pawar Dental College and Hospital Datta Meghe Institute of Medical Sciences (Deemed to be University) Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  8888839380  
Fax    
Email  rajanikanthmalaviya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajanikanth 
Designation  MDS, Ph.D, Professor 
Affiliation  Datta Meghe Institute of Medical Sciences (Deemed to be University) 
Address  OPD no. 4 Department of Oral and Maxillofacial Surgery Sharad Pawar Dental College and Hospital Datta Meghe Institute of Medical Sciences (Deemed to be University) Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  8888839380  
Fax    
Email  rajanikanthmalaviya@gmail.com  
 
Source of Monetary or Material Support  
Sharad Pawar Dental College 
 
Primary Sponsor  
Name  Sharad Pawar Dental College 
Address  Sharad Pawar Dental College and Hospital Datta Meghe Institute of Medical Sciences (Deemed to be University) Wardha Maharashtra 
Type of Sponsor  Research institution and hospital 
 
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 Sneha Patil  Sharad Pawar Dental College  OPD no. 4 Department of oral and maxillofacial surgery Sharad Pawar Dental College and Hospital Datta Meghe Institute of Medical Sciences (Deemed to be University)
Wardha
MAHARASHTRA 
8818991447

docsneha.patil07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  Kinesiologic Tape  Kinesiologic Tape with the size of 5 cm × 5 m will be used for the study. The Kinesiologic Tape will be applied into 5 equal strips with approx. 1cm of width  
Comparator Agent  No Application of Kinesiologic Tape  No Application of Kinesiologic Tape 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18 years and above.
Impacted mandibular third molar indicated for extraction
A medical history free of any systemic or pathological condition
A medical history free of any pharmacological therapy able to introduce variables into the experiment.
 
 
ExclusionCriteria 
Details  Patients not willing to be a part of the study
Patients with uncontrolled systemic diseases
Patients with incidence of skin lesions.
Patients reluctant to shave facial hair (for men)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain
Edema
Trismus 
Day 1
Day 2
Day 3
Day 7
 
 
Secondary Outcome  
Outcome  TimePoints 
Trismus  Day 1
Day 2
Day 3
Day 7
 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   10/05/2021 
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="1"
Months="7"
Days="3" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Background -The surgical removal of impacted mandibular third molars produces a significant degree of trauma to the soft tissue and bony structures of the oral cavity, which can initiate significant inflammatory reaction. As a consequence of this, patient may experience several problems counting pain, facial edema, haemorrhage, alveolar osteitis, neural paraesthesia, and limited mouth opening due to muscle spasm in the post operative period. The taping begin started to be used in sports and musculoskeletal conditions with the focus to assist the injured soft tissues (muscles and joints) helping to reduce pain. Some of the recent researches have advocated the usage of KT is very useful and impactful management of postoperative complications of maxillofacial surgery

Objectives- The motive behind this research is to compare post-operative pain, swelling and trismus following third molar surgery in both test and control groups, whether theoretically based findings about KT can be implemented clinically as well.

Methodology - The research will be a prospective randomized control split-mouth non-blinded clinical study model to evaluate the impact of the KT on post-operative sequalae following surgical removal of mandibular third molar. With the cumulative 15 patients to be allocated for removal of bilateral involved mandibular third molar. The study will be done under two groups, Group A – Test group (KT) one side of patient’s face, subjected to beige tape application. Group B – Control group (No KT) other side of patient’s face, will be the controlled group without application of KT. Each patient will undergo 2 operative surgeries at 2 week-interval conducted by the same surgeon. Immediately after extraction extra-oral application of KT will be done for test group. The KT will be applied into 5 equal strips with approx. 1cm of width and will be applied between the tragus-commissure line and the clavicle. The patients will be evaluated for post-operative pain, swelling and trismus. 

Expected Results - The use of kinesiologic tape will be effective in improvement of post-operative discomfort of the patient in the conditions of reduction of swelling, pain and trismus.

Conclusion- As kinesiologic taping originates from sports medicine, currently there are very limited evidence- based scientific studies for exploring KT application for treatment of post-operative edema in head and neck surgeries. This study will help to evaluate the use of KT enabling patients to experience a more comfortable postoperative period and helps them improving their quality of life. It may also reduce postoperative need for NSAID and analgesics, thus reducing the side effects associated with these drugs.

 
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