Comparison of Post Operative Complications with and without Use of Kinesio Tape in Patients Undergoing Surgical Removal Of Impacted Mandibular Third Molars
To compare the efficacy of Kinesio Taping after Mandibular 3rd Molar Extraction in terms of Post Op Swelling And Trismus
Design
A simple randomized controlled clinical trial with a parallel group design of 154 patients, enrolled between October 2023 and January 2024 and followed for one week after the enrollment of last patient.
Settings and conduct
Trail will be performed in Oral and Maxillofacial Surgery Department of AFID. Two groups will be made by simple randomization of patients getting surgical removal of Mandibular third Molars. One group (intervention)will get K taping done post operatively un addition to normal post operative care and second group (control) will have usual post operative care.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Having physical status 1 according to ASA classification
Surgical extraction in mandibular third molars.
Teeth which score =/>5 on Pederson's difficulty index for removal of impacted third molars
EXCLUSION CRITERIA
Patients having beard or any other hindrance in application of K- TAPE
Patient with odontogenic infection
Patient with medications that can alter pain perception.
Teeth which score <5 on Pederson's difficulty index for removal of impacted third molars
Intervention groups
Kinesio Taping will be performed in one group after 3rd Molar Extraction and No intervention will be performed in other group after 3rd Molar Extraction
Main outcome variables
Post Operative Swelling
Post Operative Trismus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230926059527N3
Registration date:2023-10-01, 1402/07/09
Registration timing:prospective
Last update:2023-10-01, 1402/07/09
Update count:0
Registration date
2023-10-01, 1402/07/09
Registrant information
Name
AMMAR Yasir
Name of organization / entity
Armed Forces Institute of Dentistry
Country
Pakistan
Phone
+92 346 7330822
Email address
seirraalphayankee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-01-07, 1402/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Post Operative Complications with and without Use of Kinesio Tape in Patients Undergoing Surgical Removal Of Impacted Mandibular Third Molars
Public title
Effects of Kinesio Taping after Third Mandibular Molar Surgical Extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having physical status 1 according to ASA classification
Surgical extraction performed in mandibular third molars.
Teeth which score =/>5 on Petersons difficulty index for removal of impacted third molars
Exclusion criteria:
Patients having beard or any other hindrance in application of K- TAPE
Pregnant women, nursing mothers, smokers
Patient with odontogenic infection
Patient with medications that can alter pain perception
Non surgical extraction.
Extraction performed in upper arch or anterior mandibular region.
Teeth with 0.5 mm or more mobility in any direction.
Teeth which score <5 on Pedersons difficulty index for removal of impacted third molars
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was performed by using lottery method(Patients with even number chits were placed in one group and with odd number chits in the second group).Allocation concealment was done using folded chits. Patients in first group got Kinesio Taping in addition to usual post op care after third molar extraction and patients in second group got normal post Op Care after mandibular third molar extraction.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of AFID
Street address
AFID CMH Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2022-04-02, 1401/01/13
Ethics committee reference number
918/Trg Dated 13 May 2020
Health conditions studied
1
Description of health condition studied
Impacted Mandibular 3rd Molar
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Post Op Swelling &Trismus
Timepoint
3th and 5th Day after intervention
Method of measurement
Post op swelling will be recorded in millimeters, from specific points already demarcated in the facial region and Trismus will be measured in millimeters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Kinesio Taping in addition to usual care will be performed in this group after surgical removal of the mandibular third molar. Tape will be left in place for 5 days and Post Operative swelling and trismus will be observed on 3th and 5th day
Category
Treatment - Devices
2
Description
Control group: Usual Care Group. Only usual care will be performed after surgical extraction of mandibular third molar. Post Operative swelling and trismus will be observed on 3th and 5th day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
AFID
Full name of responsible person
Syed Ammar Yasir
Street address
AFID, CMH Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 346 7330822
Email
seirraalphayankee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AFID
Full name of responsible person
Syed Ammar Yasir
Street address
AFID, CMH rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 314 5254504
Email
seirraalphayankee@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AFID
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Armed Forces Institute of Dentistry
Full name of responsible person
Ammar Yasir
Position
Specialty Resident
Latest degree
Medical doctor
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
AFID, CMH Rawalpindi Near Lalkurti
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 346 7330822
Fax
Email
seirraalphayankee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Armed Forces Institute of Dentistry
Full name of responsible person
Ammar Yasir
Position
Specialty Resident
Latest degree
Medical doctor
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
AFID, CMH Rawalpindi Near Lalkurti
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 346 7330822
Fax
Email
seirraalphayankee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Armed Forces Institute of Dentistry
Full name of responsible person
Ammar Yasir
Position
Specialty Resident
Latest degree
Medical doctor
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
AFID, CMH Rawalpindi Near Lalkurti
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 346 7330822
Fax
Email
seirraalphayankee@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD