| CTRI Number |
CTRI/2023/07/054738 [Registered on: 04/07/2023] Trial Registered Prospectively |
| Last Modified On: |
11/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Taping after removal of Third molar: A study |
|
Scientific Title of Study
|
Effect of Kinesio Taping after Surgical removal of Third molar: A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIWANGI JAISWAL |
| Designation |
POST GRADUATE |
| Affiliation |
KAHERS KLE V.K. INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, KLE VK INSTITUTE OF DENTAL SCIENCES, BELGAUM
JNMC CAMPUS, NEHRU NAGAR
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
7353312960 |
| Fax |
|
| Email |
jaiswalshiwangi14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ARATI NEELI |
| Designation |
READER |
| Affiliation |
KAHERS KLE V.K. INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, KLE VK INSTITUTE OF DENTAL SCIENCES, BELGAUM
JNMC CAMPUS, NEHRU NAGAR
Belgaum
KARNATAKA
590010
India |
| Phone |
9342988955 |
| Fax |
|
| Email |
aratiaqua@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr ARATI NEELI |
| Designation |
READER |
| Affiliation |
KAHERS KLE V.K. INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, KLE VK INSTITUTE OF DENTAL SCIENCES, BELGAUM
JNMC CAMPUS, NEHRU NAGAR
KARNATAKA
590010
India |
| Phone |
9342988955 |
| Fax |
|
| Email |
aratiaqua@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, KLE VK INSTITUTE OF DENTAL SCIENCES, BELGAUM , KARNATAKA |
|
|
Primary Sponsor
|
| Name |
SHIWANGI JAISWAL |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, KLE VK INSTITUTE OF DENTAL SCIENCES |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 |
| SHIWANGI JAISWAL |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY |
KLE VK INSTITUTE OF DENTAL SCIENCES
Belgaum
KARNATAKA |
7353312960
jaiswalshiwangi14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee FOR KLE VKIDS , BELGAUM, KARNATAKA |
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 |
GROUP I |
KINESIOLOGY TAPE |
| Comparator Agent |
GROUP II |
CONTROL GROUP |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to age between 18 to 40
patients who have not taken antibiotic or anti inflammatory agents one week before surgery
patients with ASA status I |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the study.
Patients with odontogenic cyst, tumors associated with impacted tooth.
Patients with presence of any systemic disorders.
Patients with smoking habit.
Pregnant or lactating female subjects.
Patient with allergy to the tape (patients who develop any itching or redness in the immediate 24 hours of tape application).
Patients who are bearded and not willing for face preparation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| POST OPERATIVE PAIN |
POST OPERATIVE PAIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| POST OPERATIVE EDEMA |
AT 0
AT POD 2
AT POD 7 |
| POST OPERATIVE TRISMUS |
AT 0
AT POD 2
AT POD 7 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
20/07/2023 |
| 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="6"
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
|
THIS STUDY IS A RANDOMIZED CONTROLLED CLINICAL TRIAL WHICH ASSESS THE EFFECTIVENESS OF KINESIO TAPE IN REDUCING POST OPERATIVE PAIN , SWELLING AND TRISMUS. |