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CTRI Number  CTRI/2026/02/103262 [Registered on: 06/02/2026] Trial Registered Prospectively
Last Modified On: 05/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [iontophoresis machine and magnesium sulphate gel]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to Compare Magnesium Sulphate Gel With and Without Iontophoresis for Jaw Muscle Pain in TMJ Disorders 
Scientific Title of Study   Comparative Evaluation of Topical Magnesium Sulphate Gel With and Without Iontophoresis in Management of Masseter Myalgia in Temporomandibular Joint Disorders A Randomized Controlled 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 Swathy M S 
Designation  Post graduate student 
Affiliation  Government dental college and research institute bangalore 
Address  Room No 1 Department of oral medicine and radiology government dental college and research institute bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9481721024  
Fax    
Email  swathyms20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Suman B 
Designation  Associate professor 
Affiliation  Government dental college and research institute bangalore 
Address  Department of oral medicine and radiology .Government dental college and research institute fort victoria campus bangalore

Bellary
KARNATAKA
560002
India 
Phone  09980839659  
Fax    
Email  drsumannag99@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Swathy M S 
Designation  Post graduate student 
Affiliation  Government dental college and research institute bangalore 
Address  Room No 1 Department of oral medicine and radiology government dental college and research institute bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9481721024  
Fax    
Email  swathyms20@gmail.com  
 
Source of Monetary or Material Support  
Room no 1 department of oral medicine and radiology Government dental college and research institute victoria hospital campus fort bangalore 560002 INDIA 
 
Primary Sponsor  
Name  DR Swathy M S 
Address  Room No 1 Department of oral medicine and radiology government dental college and research institute bengaluru 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swathy M S  government dental college and research institute bangalore  Department of oral medicine and radiology GDCRI victoria hospital campus new tharagupet bangalore
Bellary
KARNATAKA 		 09481721024

swathyms20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Government dental college and research institute bangalorer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M266||Temporomandibular joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Topical Magnesium Sulphate Gel With Iontophoresis   Topical magnesium sulphate gel iontophoresis will be performed twice weekly for four weeks. 
Comparator Agent  Topical Magnesium Sulphate Gel Without Iontophoresis  Topical magnesium sulphate gel without iontophoresis will be performed twice weekly for four weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants with TMDs having unilateral or bilateral masseter myalgia based on DC/TMD criteria.1( Annexure III)
2. Participants 18 to 60 years of age of either gender . 
 
ExclusionCriteria 
Details  F. EXCLUSION CRITERIA:
1. The presence of congenital abnormalities affecting TMJ and associated structures.
2. The presence of systemic diseases like cervicalgia or rheumatological diseases like rheumatoid arthritis, ankylosing spondylitis, lupus erythematosus, viral myalgia etc.
3. Any history of trauma ,cervical spine or TMJ surgery
4. Patients who are undergoing orthodontic treatment or recent extractions .
5. Patients currently under treatment for temporomandibular disorders.
6. Patients with history of radiation treatment to head and neck region.
7. Individuals with pacemakers and metal implants.
8. Pregnant and lactating women.
9. Patients who have limited mouth opening due to non-TMD causes such as odontogenic infections,OSMF,fractures etc.
10. Patients under medications which can affect muscle activity like muscle relaxants, antidepressants, etc
11. Patients with history of skin allergy/allergic to medications used in present treatment .
12. Patients who had any infection, lesion or trauma in the region of electrode placement 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
VAS score, maximum mouth opening (MMO), and quality of life  At baseline and after end of treatment of 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   21/02/2026 
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 Yet Recruiting 
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 - NO
Brief Summary   62 Clinically proven cases of temporomandibular joint disorder cases reporting to department of Oral Medicine and Radiology with Baseline assessment of clinical parameters VAS score, maximum mouth opening MMO and quality of life randomised allocation of  62 participants of GROUP I 31 participants Topical magnesium sulphate gel iontophoresis done twice weekly for 4 weeks and GROUP II 31 participants Topical magnesium sulphate gel application done twice weekly for 4 weeks. For both the groups assessment of the outcome measuments VAS score, maximum mouth opening MMO and quality of life Will be done before treatment immediately after first session and finally after treatment. Data collected will be compiled onto an MS Office 365 Excel worksheet and will be subjected to statistical analysis using SPSS 26.0 software. drop-outs ,if there is 5% loss of subjects during the follow up, ethical clearance obtained from the Institutional Ethical Committee and review board of Government Dental College and Research Institute, Bengaluru. 
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