| CTRI Number |
CTRI/2025/10/095806 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Combined therapy vs splints: finding better relief for jaw joint pain |
|
Scientific Title of Study
|
To assess and compare the effectiveness of a multidisciplinary approach versus occlusal splints alone in reducing pain associated with temporomandibular disorders (TMDS): 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 |
Akshaya Kumar Patra |
| Designation |
Juniour Resident |
| Affiliation |
Kalinga Institute Of Dental Sciences |
| Address |
Room no 3, Department of Prosthodontics And Crown And Bridge, Kalinga Institute Of Dental Sciences, KIIT University, Bhubaneswar, 751024
Khordha
ORISSA
751024
India |
| Phone |
8457848100 |
| Fax |
|
| Email |
akshayapatra21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswini Kumar kar |
| Designation |
Professor |
| Affiliation |
Kalinga Institute Of Dental Sciences |
| Address |
Room no 3, Department of Prosthodontics And Crown And Bridge, Kalinga Institute Of Dental Sciences, KIIT University, Bhubaneswar, 751024
Khordha
ORISSA
751024
India |
| Phone |
8763499135 |
| Fax |
|
| Email |
bapujikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshaya Kumar Patra |
| Designation |
Juniour Resident |
| Affiliation |
Kalinga Institute Of Dental Sciences |
| Address |
Room no 3, Department of Prosthodontics And Crown And Bridge, Kalinga Institute Of Dental Sciences, KIIT University, Bhubaneswar, 751024
ORISSA
751024
India |
| Phone |
8457848100 |
| Fax |
|
| Email |
akshayapatra21@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Akshaya Kumar Patra |
| Address |
Room no 3, Department of Prosthodontics And Crown And Bridge, Kalinga Institute Of Dental Sciences, KIIT University, Bhubaneswar, 751024 |
| 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 Akshaya Kumar Patra |
Kalinga Institute Of Dental Sciences |
Room no 3, Department of Prosthodontics And Crown And Bridge, Kalinga Institute Of Dental Sciences, KIIT University, Bhubaneswar, 751024
Khordha
ORISSA |
8457848100
akshayapatra21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Stabilization Splint |
maxillary stabilization splint for 4 weeks |
| Intervention |
Stabilization Splint, Physiotherapy, mindfullness-Based Intervention |
maxillary stabilization splint for 4 weeks, Cyriax soft tissue mobilization, and mindfulness sessions, each performed three times weekly for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who experienced common symptoms of TMD (i.e. impaired range of movement, impaired TM-joint function, muscle pain, TM-joint pain, or pain on movement of the mandible).
2)Patients aged between 18 to 40 years.
3)Patients willing to receive treatment after informed consent.
|
|
| ExclusionCriteria |
| Details |
1)Patients below the age of 18 years and above the age of 40 years.
2)Patients with complete or removable prosthesis with distal extensions on which it is not possible to fabricate a retentive splint.
3)Patients already having received medical, pharmacological or any form of treatments for TMD.
4)Individuals with recent facial or cervical trauma.
5)Patients under treatment for any major psychological disorders.
6)Symptoms related to disease in other components of the stomatognathic system e.g., toothache, neuralgia).
7)Cases with congenital abnormality, concomitant inflammatory or neoplastic conditions.
8)Patients not willing to participate after informed consent. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain intensity, mandibular range of motion |
baseline, 2 weeks, 1 month, 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| psychological status |
baseline, 2 months |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 randomized clinical trial aims to compare a multidisciplinary approach combining occlusal splint therapy, physiotherapy, and mindfulness-based intervention with occlusal splints alone in reducing TMD related pain and improving function. A total of 154 patients aged between18 to 40 years diagnosed using RDC TMD criteria will be randomly assigned by block randomization to either the splint only group or the multidisciplinary group. Interventions will be conducted over four weeks, with follow-ups at baseline, 2 weeks, 1 month, and 2 months. Pain intensity, mandibular range of motion, and psychological well-being will be evaluated. |