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A study comparing splints, medicines and electrical stimulation therapy for the treatment of jaw muscle pain and jaw movement problems

COMPARITIVE EVALUATION OF EFFICACY OF OCCLUSAL THERAPY, TENS AND PHARMACOTHERAPY ON TREATMENT OF TMD - TMD-M

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/113084
Enrollment
75
Registered
2026-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M266- Temporomandibular joint disorders

Interventions

Intervention1: Occlusal Therapy: Hard acrylic maxillary stabilization splint with full coverage flat plane design and canine guidance. Participants instructed to wear splint during nighttime throughou

Sponsors

Dr Bhimrao Ramji Ambedkar Government Medical College Kannauj
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with myogenous temporomandibular disorder according to DC TMD Axis I criteria. Pain of muscle origin aggravated by jaw movement, function or parafunction. Replication of pain on palpation of masseter and or temporalis muscle with one kilogram pressure for five seconds. Pain localized, myofascial, or myofascial with referral. Symptoms present for more than four weeks. Participants willing to provide informed consent and comply with study protocol.

Exclusion criteria

Exclusion criteria: Current or recent use within previous four weeks of analgesics, non steroidal anti inflammatory drugs, muscle relaxants or antidepressants. Missing maxillary or mandibular central incisors. Inability to attend complete treatment and follow up schedule. Strong preference for a specific treatment modality. Complete dentures or distal extension removable partial dentures. History of malignant tumour involving face or jaw. History of jaw fracture or temporomandibular joint surgery. Previous temporomandibular disorder treatment. Previous orthodontic treatment. Presence of oral submucous fibrosis, migraine or significant systemic illness.

Design outcomes

Primary

MeasureTime frame
Pain intensity assessed using Visual Analog Scale score ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.Timepoint: Pain intensity assessed using Visual Analog Scale score ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.

Secondary

MeasureTime frame
Maximum Mouth Opening measured in millimetresTimepoint: Baseline, 2 weeks, 4 weeks, 8 weeks, 3 months;Jaw Functional Limitation Scale Eight scoreTimepoint: Baseline, 2 weeks, 4 weeks, 8 weeks, 3 months;Oral Health Impact Profile Fourteen scoreTimepoint: Baseline, 2 weeks, 4 weeks, 8 weeks, 3 months;Muscle Tenderness ScoreTimepoint: Baseline, 2 weeks, 4 weeks, 8 weeks, 3 months

Countries

India

Contacts

Public ContactHarshika Gautam

Dr. Bhimrao Ramji Ambedkar Government medical college ,Kannauj

dr.harshika@outlook.com9453308870

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026