FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/067013 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 01/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to assess the effects of two drugs -aqueous titanium and diclofenac, that are applied as patches on skin, in patients with jaw pain at their joints 
Scientific Title of Study   Effect of aqueous titanium and diclofenac transdermal patches for pain management in temporomandibular disorders-a randomized clinical 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 Jeeevitha M 
Designation  Associate Professor 
Affiliation  Government Dental College and Research Institute, Bangalore 
Address  Associate Professor, Department of oral medicine and radiology, Government Dental College and Research Institute, Bangalore

Bangalore
KARNATAKA
560000
India 
Phone  8618319993  
Fax    
Email  mdrjeevitha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Saranya Devi V 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Research Institute 
Address  Department of Oral Medicine and Radiology, Room No-1, Government Dental College and Research Institute, Victoria Hospital, Near City Market, Kalasipalaya, Bangalore.

Bangalore
KARNATAKA
560002
India 
Phone  8610428317  
Fax    
Email  saranyadevi1711@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Saranya Devi V 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Research Institute 
Address  Department of Oral Medicine and Radiology, Room No-1, Government Dental College and Research Institute, Victoria Hospital, Near City Market, Kalasipalaya, Bangalore.

Bangalore
KARNATAKA
560002
India 
Phone  8610428317  
Fax    
Email  saranyadevi1711@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College and Research Institute, Bangalore 
 
Primary Sponsor  
Name  Dr. Jeevitha M 
Address  Associate Professor, Department of Oral Medicine and Radiology, Government Dental College and Research Institute, Bangalore 
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 Saranya Devi V  Government Dental College and Research Institute  Department of Oral Medicine and Radiology, Room No-1, Victoria Hospital, Near City Market, Kalsipalaya.
Bangalore
KARNATAKA 
8610428317

saranyadevi1711@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Dental College and Research Institute Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M241||Other articular cartilage disorders, (2) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Topical aqueous titanium transdermal patch  Topical aqueous titanium transdermal patch contains titanium concentration of 540 ml/l. It is an agent that releives pain by reducing inflammation, and also helps in nerve regeneration.It has to be applied over the most painful area for 12 hours/ day for 2 weeks. 
Comparator Agent  topical diclofenac transdermal patch  100 mg topical diclofenac transdermal patch is to be applied to the most painful area for 12 hours a day for 2 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients with temporomandibular disorders presenting with pain based on DC-TMD criteria with Visual analog scale scores of 1-7.
2.Patients who are willing to participate in the study. 
 
ExclusionCriteria 
Details  1.Patients who are allergic to titanium, diclofenac and polyurethane materials.
2.Patients with history of trauma to temporomandibular and maxillofacial region.
3.Patients with previous history of systemic inflammatory conditions of joints like arthritis, gout etc.
4.Previously treated patients for temporomandibular disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of pain by VAS scores and during rest and during jaw movements.
Assessment of maximum range of mouth opening, with and without pain.
 
7th,15th and 21st days
 
 
Secondary Outcome  
Outcome  TimePoints 
• Tenderness to palpation of the TMJs (laterally and posteriorly).  7th,15th and 21st days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   18/05/2024 
Date of Study Completion (India) 14/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/06/2024 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  
A total of 60 patients will be selected based on the set inclusion and exclusion criteria. A written informed consent will be obtained from each patient before the start of the study. Case history related to TMD will be collected by means of Diagnostic Criteria questionnaire and subsequent clinical examination will be performed. Pain will be assessed by means of visual analog scale. The radiographic examination of the TMJ will be done after the clinical examination to rule out fractures, cysts etc.
Patients will be allocated into 2 groups, Group A[AQUEOUS TITANIUM PATCH 540 ml/l] and Group B[DICLOFENAC PATCH 100 mg] of 30 each by simple random method using a computer generated sequence. Their allocation is concealed by providing them with sequentially numbered opaque envelopes with patient number on outside. The envelope is placed at the custody of the guide and will be opened only during intervention. To eliminate bias, both outcome assessor and patient will be blinded. Code breaking will be performed after statistical analysis. A patch test will be done by the application of test patch on the forearm and observing the skin reaction for 1 hour for detection of allergy. If the patient experiences any signs of allergy, he will be excluded from the study. If no allergic reactions develop the patient will be provided with respective transdermal patches for application onto the painful area for 12 hours a day over 2 weeks duration. No adjuvant therapy is given to the patient during the study period. After 2 weeks the patch application is withdrawn. The patient will be reviewed
and reassessed for outcome measures, pain by visual analog scale during rest and during jaw movements and maximum range of mouth opening, with and without pain periodically on 3rd,7th,15th and 21st days.If patient develops any adverse effects during the study at any point of time, he will be excluded and appropriate therapy will be given.
 
Close