Skip to content

A study to assess the effect of occlusal splint therapy on jaw position and airway space in patients with jaw muscle pain

Evaluating the Impact of Occlusal Splint Therapy on Upper Airway Dimensions and Mandibular Condylar Position in Myofascial Pain Patients with Average Skeletal Growth Patterns: A CBCT-based Randomized Control Trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084068
Enrollment
50
Registered
2025-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: M609- Myositis, unspecified

Interventions

Intervention1: Occlusal Splint Therapy & Pharmacotherapy: Description: The intervention group will receive customized occlusal splint therapy and Pharmacotherapy. Participants will be prescribed NSA

Sponsors

Dr. Amol Karagir
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age Range: 20-30 years. Diagnosis: Myogenic temporomandibular disorders (TMD), specifically myofascial pain. Skeletal Growth Pattern: Average skeletal growth pattern (determined by composite cephalometric analysis). Consent: Written informed consent provided. No Prior TMJ Treatment: No previous temporomandibular joint or occlusal therapy.

Exclusion criteria

Exclusion criteria: Systemic Diseases: Conditions affecting TMJ or airway (e.g., rheumatoid arthritis, sleep apnea). Craniofacial Anomalies: Cleft palate, craniosynostosis, etc. Previous Orthodontic/Surgical Treatment: Orthodontic or craniofacial surgery. Pregnancy: Excluded due to hormonal influences and CBCT radiation. Respiratory Conditions: Asthma, COPD, chronic rhinitis, etc. Psychiatric Disorders: Conditions affecting compliance (e.g., schizophrenia, major depression). TMJ Degenerative Diseases: Osteoarthritis, ankylosis, etc. Malocclusion/Skeletal Discrepancies: Class II, Class III, severe open bite. Medication Use: Medications affecting muscle or TMJ function (e.g., corticosteroids). Non-compliance: Inability to adhere to the study protocol.

Design outcomes

Primary

MeasureTime frame
1.Changes in Upper Airway Dimensions measured via CBCT Total Airway Volume: From nasopharynx to hypopharynx, measured in mm , Segmental Airway Volumes: Nasopharyngeal Volume in mm . Oropharyngeal Volume in mm . Hypopharyngeal Volume in mm Minimum Cross-Sectional Area : Smallest area within the airway, measured in mm Airway Length: Distance from the nasopharynx to the hypopharynx, measured in mm Presence of Obstructions or Anomalies: Identification of any airway obstructions (e.g., adenoids, hypertrophy). 2.Changes in Mandibular Condylar Position measured via CBCT Joint Space Measurements, Condylar Ratio, Angular and Morphological Parameters: Sagittal Condylar Guidance AngleTimepoint: Baseline: Before initiation of the intervention 3 Months: Final assessment using CBCT

Secondary

MeasureTime frame
1.Comparison Between Groups: Differences in upper airway dimensions and mandibular condylar position across all groups: 2. Correlation Analysis: Relationship between changes in upper airway dimensions and alterations in mandibular condylar position. 3. Symptom Improvement: Patient-reported improvement in TMJD symptoms (e.g., pain reduction, increased jaw mobility). 4. Clinical Observations: Evaluation of the effectiveness of occlusal splint therapy in enhancing airway function and TMJ alignment. Timepoint: Baseline: Before initiation of the intervention 6 Weeks: Interim assessment for pain and functional improvement 3 Months: Final assessment using CBCT and patient-reported outcomes

Countries

India

Contacts

Public ContactDr Amit Mhapuskar

Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune

amit.mhapuskar@bharatividyapeeth.edu9850285143

Outcome results

None listed

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