| CTRI Number |
CTRI/2024/11/076700 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Sound Wave (ultrasound) Therapy and Medications for Reducing Facial Pain in Patients |
|
Scientific Title of Study
|
Comparative evaluation of efficiency of ultrasound therapy and pharmacotherapy in individuals with facial pain: An Observational Study |
| 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 Suresh Venugopalan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee high Road, Velapanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9543192858 |
| Fax |
|
| Email |
suresh@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrutha Shenoy |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee high Road, Velapanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
amruthashenoyd.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrutha Shenoy |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee high Road, Velapanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
amruthashenoyd.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai, Tamil Nadu, India, 600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospitals |
| Address |
Poonamallee High Road, Velapanchavadi, Chennai 600077, Tamil Nadu, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Amrutha Shenoy |
Saveetha Dental College and Hospitals |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai 600077
Chennai
TAMIL NADU |
9819122808
amruthashenoyd.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pharmacotherapy |
Participants receive a combination of muscle relaxants (aceclofenac and tizanidine) twice a day for a week. |
| Comparator Agent |
Placebo |
Participants use an ultrasound handle with ultrasound gel without the power being switched on and receive multivitamin tablets (placebo pills) twice daily for a week. |
| Intervention |
Ultrasound therapy |
Participants receive ultrasound therapy at the pain site with a 1 MHz probe in continuous mode at an intensity level of 2.0 watts/cm² for 20 minutes, up to 3 sessions per week for 1 month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with facial pain
Diagnosed with TMD-P according to RDC/TMD criteria.
Facial pain localized to the TMJ or experienced within the last six months
|
|
| ExclusionCriteria |
| Details |
General joint or muscle diseases.
Symptoms referred to other parts of the stomatognathic system, such as toothaches or neuralgia.
Recent history of peptic ulceration or gastrointestinal bleeding.
Disorders of coagulation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain reduction using VAS scale |
baseline(0 months) and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in mouth opening |
baseline (0 months) and 1 month |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Temporomandibular joint disorders (TMDs) and associated myalgia can cause severe pain in patients at rest or during any physical activity leading to alteration in their overall quality of life. Various treatment options have been proposed for conservative management of pain localized to the temporomandibular joint disorders. This study aims to assess the efficiency of using ultrasound therapy and pharmacotherapy for management of pain in affected individuals. |