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ROLE OF OCCLUSAL SPLINT THERAPY IN PREVENTING TEMPOROMANDIBULAR JOINT DYSFUNCTION FOLLOWING MANDIBULAR ANGLE OR BODY FRACTURE- A RANDOMIZED CONTROLLED TRIAL

ROLE OF INTER-OCCLUSAL SPLINT THERAPY IN PREVENTING TEMPOROMANDIBULAR JOINT DYSFUNCTION FOLLOWING MANDIBULAR ANGLE OR BODY FRACTURE- A RANDOMIZED CONTROLLED TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091527
Enrollment
30
Registered
2025-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: occlusal splint: A 3mm occlusal splint for 2 months Control Intervention1: non: patient will not be given any occlusal splint for 2 month

Sponsors

kothiwal dental college and research center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who will be categorized as ASA-I and ASA-II based on the American Society of Anesthesiologists classification for physical status Patients with isolated fractures of the body or angle of the mandible Patients treated within 5 days of trauma Patients who will give written informed consent for participation in the study and to undergo necessary investigations and required treatment

Exclusion criteria

Exclusion criteria: Pregnant or lactating women. Patients having extensive prosthetic restorations. Patients having multiple, bilateral or comminuted fracture of body or angle of mandible or previous history of maxillofacial trauma. Patients having mandibular fractures along with condylar fracture or other facial bone fracture. Patients suffering or having pre-existing TMJ disorders, arthritis, or ankylosis and systemic bone diseases (e.g., osteoporosis, osteopetrosis, rheumatoid arthritis). Patients with the history of orthodontic/orthognathic surgery. Patients with history of neuromuscular disorders (e.g., Parkinson s disease, cerebral palsy) and psychiatric disorders affecting compliance.

Design outcomes

Primary

MeasureTime frame
TMJ or Muscle pain (VAS Score 0-10). Maximum Mouth Opening (MMO in mm): Measured by inter-incisal distance. TMJ Clicking (Present/Absent) Jaw Deviation (in mm). Timepoint: All the outcomes will be evaluated at 2 weeks,1month and 2 months after ORIF.

Secondary

MeasureTime frame
all sign & symptoms of TMDsTimepoint: 2weeks, 1month, 2months of trauma

Countries

India

Contacts

Public ContactDR PINKY RANA

KOTHIWAL DENTAL COLLEGE AND RESEACH CENTER

Manpreet911@gmail.com09412552255

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026