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Comparison of Kinesiologic Taping and Pressure Dressing application to Reduce Postoperative Swelling and Pain after Orthognatic Surgery In Skeletal Class III Patients

Protocol summary

Study aim
Comparison of Kinesiologic Taping and Pressure Dressing application to Reduce Postoperative Swelling and Pain after Orthognatic Surgery
Design
single blinded randomized clinical trial with parallel groups on 30 patients. Excel software rand function was used for randomization.
Settings and conduct
Patients undergoing bilateral bimaxillary surgery at the Department of Oral and Maxillofacial Surgery, Imam Hossein hospital, Shahid Behehsti University of Medical Sciences, were included in the present study. Group I included 30 patients and had kinesio tape applied. Group II included 30 patients and had pressure dressing applied. Swelling was assessed using a flexible ruler by measuring the distance between 6 landmarks. The visual analog scale for pain scores were recorded postoperatively at 30 minutes, 1, 6, 12, and 24 hours, and day 2, 5 post operation. The effects of operative time, patient age, gender and BMI were standardized.
Participants/Inclusion and exclusion criteria
Class III skeletal patients who are going under bimaxillary surgery bilaterally. Patients who were: using medications had systemic conditions had osteogenic systemic disease only needed surgery in one jaw pregnant allergic to the tape allergic to the medication protocol under 18 were excluded from the study
Intervention groups
group I: pressure dressing group Four 4*4 inch fluffed sterile gauzes are placed on each side of the face, supported by surgical fix. group II: Kinesio taping group The length of the tape is measured for each patient from the clavicle to the end of the swollen area. The tape passes the Cervical, Subglottic, Mandibular, Submandibular, Pre-auricular, and Parotid lymph nodes until they reach the zygomatic arch. Then, along the length of the master muscle, tape is attached for more support.
Main outcome variables
edema, pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211205053279N1
Registration date: 2022-11-26, 1401/09/05
Registration timing: registered_while_recruiting

Last update: 2022-11-26, 1401/09/05
Update count: 0
Registration date
2022-11-26, 1401/09/05
Registrant information
Name
Mostafa Alam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 8012
Email address
mostafa_alam@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-24, 1401/03/03
Expected recruitment end date
2023-02-22, 1401/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Kinesiologic Taping and Pressure Dressing application to Reduce Postoperative Swelling and Pain after Orthognatic Surgery In Skeletal Class III Patients
Public title
Kinesiologic Taping and Pressure Dressing comparison in swelling and pain management after orthognatic surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Skeletal class III patients, indication for BSSO setback and LeFort1 advancement
Exclusion criteria:
Syndromic Under medications indicates rotational surgery one jaw needs surgery pregnant systemic condition allergic to tapes
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized blocks method classified by age and sex
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
Research Ethics Committees of Research Institute of Dental Sciences- Shahid Beheshti University of M
Street address
No 26, Sharifimanesh St., Andarzgoo Blvd.
City
Tehran
Province
Tehran
Postal code
1934963954
Approval date
2021-12-28, 1400/10/07
Ethics committee reference number
IR.SBMU.DRC.REC.1400.142

Health conditions studied

1

Description of health condition studied
swelling and pain after orthognathic surgery
ICD-10 code
Q67.4
ICD-10 code description
Other congenital deformities of skull, face and jaw

Primary outcomes

1

Description
tissue swelling
Timepoint
immediately post- op; day 1,2,5 post-op
Method of measurement
n order to assess the extent of swelling, 5 distances (in mm) were measured at 6 points on the face with a flexible ruler, from the angle of the mandible to: 1) the tragus skin point, 2) the out- er angle of the eye, 3) the nasal border – wing of the nos- tril 4) the lip angle, and 5) the soft pogonion)

2

Description
pain
Timepoint
30 mins, 1,6,12, 24 hours after surgery. day 2,5 post-op.
Method of measurement
VAS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Kinsesio taping.kinesio taping is a therapeutic taping technique which alleviates pain and facilitates lymphatic drainage by microscopically lifting the skin. The patch is made of nylon and kotton to match the range of natural skin in motion. The adhesive is applied to clean stretched skin. the treatment will last for 7 days. The brand used in this study is Himmel, made in South Korea.
Category
Treatment - Devices

2

Description
Intervention group: Pressure dressing. 4 fluffed sterile gauzes, supported by a surgical fix will be place on each side of the face for a week.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Mostafa Alam
Street address
Madani Ave.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@ehmc.ir
Web page address
https://www.ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of medical sciences, Bldg. N0.2, Arabi Ave, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Alam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti University of Medical Sciences, School of dentistry, Daneshjoo Blvd., Evin, Chamran Exp., Tehran.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
22175350- 021
Email
mostafa_alam1@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Alam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti University of Medical Sciences, school of dentistry, Daneshjoo Blvd., Evin, Chamran Exp., Tehran.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
22175350- 021
Email
mostafa_alam1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Alam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti University of Medical Sciences, school of dentistry, Daneshjoo Blvd., Evin, Chamran Exp., Tehran.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
22175350- 021
Email
mostafa_alam1@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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