| CTRI Number |
CTRI/2025/11/097244 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“Effect of Kinesio Taping on Pain, Swelling, and Mouth Opening After Jaw Surgery” |
|
Scientific Title of Study
|
Efficacy of Kinesio Taping Therapy on Swelling, Trismus and Pain after Orthognathic Surgery: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi S Mishra |
| Designation |
Post graduate |
| Affiliation |
Meenakshi Academy of Higher Education and research |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam main road, maduravoyal, chennai-600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9730370202 |
| Fax |
|
| Email |
sakshim2099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manodh P. |
| Designation |
Professor, Guide |
| Affiliation |
Meenakshi Academy of Higher Education and research |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam main road, maduravoyal, chennai-600095
Chennai
TAMIL NADU
600095
India |
| Phone |
09840439655 |
| Fax |
|
| Email |
drmanodh.omfs@madch.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi S Mishra |
| Designation |
Post graduate |
| Affiliation |
Meenakshi Academy of Higher Education and research |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam main road, maduravoyal, chennai-600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9730370202 |
| Fax |
|
| Email |
sakshim2099@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sakshi Mishra |
| Address |
Meenakshi Ammal Dental college and hospital, Alapakkam main road, maduravoyal, chennai-600095 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sakshi S Mishra |
Meenakshi Ammal Dental college and hospital |
Room No. 5, Department of Oral & Maxillofacial Surgery, Alapakkam main road, maduravoyal, chennai-600095
Chennai
TAMIL NADU |
09730370202
sakshim2099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committtee Meenakshi Ammal Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M265||Dentofacial functional abnormalities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio Taping |
Kinesio Taping involves applying a special elastic tape on the skin over the cheek and jaw area after surgery for 7 days. The tape is applied in a specific pattern to help reduce swelling, improve blood and lymph flow, and support faster healing. It stays on the skin for a few days and is painless to apply and remove. |
| Comparator Agent |
Standard post-operative care (analgesics, antibiotics, cold compress, and routine instructions) |
Patients in the comparator group will receive the usual post-surgical care after wisdom tooth removal. This includes medications for pain relief, antibiotics if prescribed, cold compresses, and general instructions for diet and oral hygiene to be followed for 5-7 days. No Kinesio Tape will be applied in this group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 40 years undergoing elective orthognathic surgery.
Willing to adhere to follow-up visits and postoperative protocols.
No prior orthognathic surgery or any other surgery in the head & neck region or any history of major facial trauma. |
|
| ExclusionCriteria |
| Details |
Patients with active infections or skin conditions.
Individuals with chronic pain disorders or neurological conditions affecting pain perception.
Patients with systemic conditions that could affect healing like diabetes, coagulation disorders, etc.
Patients using systemic steroids or immunosuppressive therapy.
Patients with a history of allergies to adhesive tapes or components of Kinesio Tape.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Pain levels assessed using Visual Analog Scale (VAS).
-Swelling measured using standardized techniques. (tape measure)
-Trismus evaluated by measuring inter-incisal opening.
|
preoperative,Day 1, day 3, day 7, day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
20/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sakshim2099@gmail.com].
- For how long will this data be available start date provided 20-08-2025 and end date provided 20-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the efficacy of Kinesio Taping (KT) therapy in reducing postoperative swelling, trismus, and pain following orthognathic surgery. Postoperative edema and limited mouth opening are common sequelae after bimaxillary or mandibular osteotomies, often impacting recovery and quality of life. Kinesio taping, a non-invasive method that facilitates lymphatic drainage and supports muscle function, has shown potential benefits in reducing inflammation and discomfort in other surgical settings. Participants will be randomly assigned to either the intervention group (receiving KT therapy along with standard postoperative care) or the control group (receiving standard care alone). Outcomes will be assessed at multiple postoperative intervals using standardized measurements for facial swelling, maximal interincisal opening, and pain (VAS). The study seeks to determine whether KT therapy provides a significant adjunctive benefit in enhancing postoperative recovery in orthognathic surgery patients. |