| 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
|
|
|
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
|
|
|
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. |