| 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
|
|
|
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
|
|
|
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. |