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
|
|
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
|
|
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. |