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CTRI Number  CTRI/2021/07/035272 [Registered on: 29/07/2021] Trial Registered Prospectively
Last Modified On: 28/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Elastic therapeutic tape and/or pain killer skin patch in control of consequences after surgery of broken lower jaw -A Prospective Randomized Clinical Trial. 
Scientific Title of Study   Effect of Kinesiotaping and/or Transdermal Diclofenac Patch in control of Surgical Morbidity of Mandibular Angle Fracture Management-A Prospective Randomized Clinical Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr PATRUNI SAI PRASANNA  
Designation  BDS, Post graduate student 
Affiliation  Vishnu Dental College 
Address  Room no: 2, Block-3, Vishnu Dental College, Vishnupur, Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  7893191323  
Fax    
Email  saiprasanna.patruni@vdc.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  DrUSHIVAJI RAJU 
Designation  MDS,Professor,Oral and Maxillofacial Surg 
Affiliation  Vishnu Dental College 
Address  Room no: 2, Block-3, Vishnu Dental College, Vishnupur, Bhimavaram.

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9966351997  
Fax    
Email  shivajiraju.u@vdc.edu.in  
 
Details of Contact Person
Public Query
 
Name  DrUSHIVAJI RAJU 
Designation  MDS,Professor,Oral and Maxillofacial Surg 
Affiliation  Vishnu Dental College 
Address  Room no: 2, Block-3, Vishnu Dental College, Vishnupur, Bhimavaram.

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9966351997  
Fax    
Email  shivajiraju.u@vdc.edu.in  
 
Source of Monetary or Material Support  
VISHNU DENTAL COLLEGE,VISHNU EDUCATIONAL SOCIETY,VISHNUPUR,BHIMAVARAM-534202 
 
Primary Sponsor  
Name  Vishnu Dental College 
Address  Room no: 2, Block-3, Vishnu Dental College, Vishnupur, Bhimavaram-534202 
Type of Sponsor  Other [Private Dental college/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 SAI PRASANNA PATRUNI  Vishnu Dental College  Room no: 2,Department of oral and maxillofacial surgery, Block-3, Vishnu Dental College, Vishnupur, Bhimavaram-534202
West Godavari
ANDHRA PRADESH 
7893191323

saiprasanna.patruni@vdc.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE VISHNU DENTAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S026||Fracture of mandible,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Kinesio Tape   1. Kinesio tape is applied to the skin overlying the fractured mandible, following open reduction and internal fixation for three days 
Comparator Agent  Transdermal Diclofenac patch  Transdermal Diclofenac patch is applied to the deltoid region or chest region and pain is evaluated using visual analogue scale. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  • Patients of age 18-55 years.
• Patients willing to give an informed consent.
• Patients with Mandibular fractures involving mandibular angle.
• Cases of Mandibular angle fracture which are treated under Local anesthesia or General Anesthesia
 
 
ExclusionCriteria 
Details  • Patients not willing to give an informed consent.
• Patients with fractures not involving the mandibular angle.
• Patients who are not willing to undergo ORIF.
• Patients who are allergic to NSAIDs.
• Patients with a history of renal pathology, bronchial asthma, active peptic ulceration, cardiac surgeries, bleeding disorders.
• Lactating and pregnant women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain, Post-operative swelling and overall satisfaction are measured.  Pain and post operative swelling on DAY 0,DAY 1,DAY 2 and DAY 3 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
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)   02/08/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The management of lower jaw fractures by plating is the most common procedure in oral surgery. However, there may be a pain, swelling after surgery which would negatively affect the patient’s quality of life.

There are several methods for the management of this yet no single method is effective in treating this without producing undesirable side effects.

  Kinesio Tape (a type of plaster that is applied on the skin) is an elastic therapeutic tape with its origin from sports science which is used to relieve pain by supporting injured muscles and joints. The use of this technique might also be beneficial for postoperative management after head and neck surgery in reducing swelling and pain.

The most commonly used methods for the management of pain and swelling are pain killers in various routes. Transdermal (pain killer in patch form attached to the skin) is commonly used nowadays due to its fewer side effects and ease of application.

The aim of the study is to find out the effect of Kinesio taping and/or transdermal painkiller patch in control of pain, swelling and to measure the overall satisfaction of the patient after undergoing surgery for lower jaw fracture. Patients after fulfilling inclusion and exclusion criteria are divided into 3 groups in which one group is given both kinesiotape and painkiller patch, in 2nd group only kinesiotaping is done, in the 3rd group only painkiller patch is applied and pain, swelling is measured at specific points of time.

 
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