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
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Akshaya Kumar Patra
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- pain intensity, mandibular range of motion
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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).
- •Patients aged between 18 to 40 years.
- •Patients willing to receive treatment after informed consent.
Exclusion Criteria
- •Patients below the age of 18 years and above the age of 40 years.
- •Patients with complete or removable prosthesis with distal extensions on which it is not possible to fabricate a retentive splint.
- •Patients already having received medical, pharmacological or any form of treatments for TMD.
- •Individuals with recent facial or cervical trauma.
- •Patients under treatment for any major psychological disorders.
- •Symptoms related to disease in other components of the stomatognathic system e.g., toothache, neuralgia).
- •Cases with congenital abnormality, concomitant inflammatory or neoplastic conditions.
- •Patients not willing to participate after informed consent.
Outcomes
Primary Outcomes
pain intensity, mandibular range of motion
Time Frame: baseline, 2 weeks, 1 month, 2 months
Secondary Outcomes
- psychological status(baseline, 2 months)
Investigators
Akshaya Kumar Patra
Kalinga Institute Of Dental Sciences