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CTRI Number  CTRI/2026/02/103368 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Injection of hypertonic dextrose (prolotherapy) for TMJ dysfunction.]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study Comparing 12.5% and 25% Dextrose Injections for Treating TMJ Disorders.  
Scientific Title of Study   Comparative evaluation of efficacy of 12.5% Vs 25% Dextrose Prolotherapy on Temporomandibular joint dysfunction – A Single blind 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 Jyothsna M 
Designation  Post Graduate Student 
Affiliation  KVG Dental College and Hospital 
Address  Room no:2, Department of OMFS, KVG Dental College and Hospital Kurunjibhag, Sullia D K Karnataka Dakshina Kannada KARNATAKA 574327 India

Dakshina Kannada
KARNATAKA
574327
India 
Phone  8884751503  
Fax    
Email  drjyothsna6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prasanna Kumar D 
Designation  Professor and Head of Department 
Affiliation  KVG Dental College and Hospital 
Address  Department of Oral and Maxillofacial Surgery KVG Dental College and Hospital, Kurunjibhag, Sullia D K Karnataka Dakshina Kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448177525  
Fax    
Email  dr_prasanna_74@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Prasanna Kumar D 
Designation  Professor and Head of Department 
Affiliation  KVG Dental College and Hospital 
Address  Room no:2, Department of Oral and Maxillofacial Surgery KVG Dental College and Hospital, Kurunjibhag, Sullia D K Karnataka Dakshina Kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448177525  
Fax    
Email  dr_prasanna_74@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Jyothsna M 
Address  KVG Dental College and Hospital, Kurunjibhag, Sullia DK, Karnataka-574327 
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 Jyothsna M  KVG Dental College and Hospital  Department of Oral and Maxillofacial Surgery KVG Dental College and Hospital Kurunjibhag Sullia D K Dakshina Kannada KARNATAKA 574327 India
Dakshina Kannada
KARNATAKA 		 8884751503

drjyothsna6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with Temporomandibular joint dysfunction experiencing TMJ pain, clicking and deviation. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  12.5 Percent Dextrose  Prolotherapy with 1 mL of 12.5 percent dextrose solution injected into the retrodiscal tissue and inferior joint space of the TMJ. The solution is prepared by diluting 25 percent dextrose in a 1:1 ratio with sterile normal saline.  
Intervention  25 Percent Dextrose  Prolotherapy with 1 mL of 25 percent dextrose solution injected into the retrodiscal tissue and inferior joint space of the temporomandibular joint (TMJ).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients aged between 18 to 50 years diagnosed with TMD.
2. Patients ready to give informed consent and willingness to comply with follow-up visits.
3. Presence of persistent TMJ pain for more than 3 months.
4. Limited jaw mobility or joint noises (clicking, crepitations) associated with TMD.
5. Has not undergone any prior treatment for TMD. 
 
ExclusionCriteria 
Details  1. History of TMJ surgery or severe TMJ degenerative disease.
2. Presence of systemic inflammatory conditions (e.g., rheumatoid arthritis, lupus) or blood dyscrasias are excluded from the study.
3. Recent use of corticosteroid injections.
4. Pregnancy or lactation.
5. Active infection or tumor in the injection site.
6. Severe psychiatric disorders that may affect pain perception and compliance.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy of 12.5 percent versus 25 percent dextrose prolotherapy on temperomandibular joint dysfunction on pain using VAS scale, maximum mouth opening using interincisal distance, TMJ tenderness checked by palpation, presence or absence of TM joint sounds(clicking/crepitations) checked by palpation.  Post operative 2 weeks, 4 weeks, 1 month and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Presence or absence of deviation during mouth opening.
 		 Baseline, 2 weeks, 4 weeks, 1 month, 3 months. 
2. Any adverse events related to injection (swelling, prolonged pain)  Within 48 hours and at each follow up 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 2 
Date of First Enrollment (India)   17/02/2026 
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   This is a single-center, single-blind, randomized controlled trial evaluating the comparative efficacy of 12.5% versus 25% dextrose prolotherapy in patients with temporomandibular joint dysfunction. The study aims to assess improvement in pain, joint function, and joint sounds over a 3-month follow-up period using validated outcome measures such as the Visual Analog Scale (VAS), maximum interincisal opening, and presence of TMJ clicking. 
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