calibrated splints in treatment of internal derangement with anterior disc displacement

EVALUATION OF T-SCAN CALIBRATED AND INK RIBBON CALIBRATED OCCLUSAL SPLINTS IN TREATMENT OF TEMPOROMANDIBULAR JOINT INTERNAL DERANGEMENT WITH ANTERIOR DISC DISPLACEMENT: A CLINICAL COMPARATIVE STUDY.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/12/039050

Enrollment

Registered

2021-12-30

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

Health Condition 1: M272- Inflammatory conditions of jaws Health Condition 2: M249- Joint derangement, unspecified

Interventions

Intervention1: T-SCAN CALIBRATED HARD OCCLUSAL SPLINTS: T-SCAN CALIBRATED HARD OCCLUSAL SPLINTS IS FABRICATED ON CAST MODEL USING ACRYLIC MATERIAL AFTER IMPRESSION MAKING, FACEBOW TRANSFER AND CLAIBRT

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects above 18 years.2.Patient presenting a clear-cut clinical diagnosis of internal derangement of temporomandibular joint according to diagnostic criteria which includes cases under ICD-9 524.63; ICD-10 M 26.63.(International Classification of Diseases).3.MRI suggestive of internal derangement of temporomandibular joint.

Exclusion criteria

Exclusion criteria: 1. Presence of known connective tissue or autoimmune disease. 2. Prior TMJ surgeries. 3. Rheumatoid arthritis and Osteoarthritis. 4. History of major jaw trauma. 5. Syndrome patients. 6. Prior interventions such as arthrocenthesis and arthroscopy. 7. Concurrent use of steroid, muscle relaxants and narcotics. 8. Patients on anti-depressants.

Design outcomes

Primary

Measure	Time frame
I. CLINICAL ASSESSMENTâ?? Bilateral temporomandibular joint A.SIGNS: 1. Tenderness on palpation of the joint. 2. Tenderness in muscle of mastication. 3. Interincisal distance. 4. Protrusion. 5. Lateral excursion (right and left). 6. Deviation during jaw opening and closing. 7. Crepitus. B SYMPTOMS: 1. Pain on mouth opening. 2. Clicking sounds. 3. TMJ locking.Timepoint: I. CLINICAL ASSESSMENTâ?? Bilateral temporomandibular joint evaluated pre treatment, at 1 day, 1 month, 3 month, 6 month. A.SIGNS: 1. Tenderness on palpation of the joint. 2. Tenderness in muscle of mastication. 3. Interincisal distance. 4. Protrusion. 5. Lateral excursion (right and left). 6. Deviation during jaw opening and closing. 7. Crepitus. B SYMPTOMS: 1. Pain on mouth opening. 2. Clicking sounds. 3. TMJ locking.	—

Measure

Time frame

I. CLINICAL ASSESSMENTâ?? Bilateral temporomandibular joint A.SIGNS: 1. Tenderness on palpation of the joint. 2. Tenderness in muscle of mastication. 3. Interincisal distance. 4. Protrusion. 5. Lateral excursion (right and left). 6. Deviation during jaw opening and closing. 7. Crepitus. B SYMPTOMS: 1. Pain on mouth opening. 2. Clicking sounds. 3. TMJ locking.Timepoint: I. CLINICAL ASSESSMENTâ?? Bilateral temporomandibular joint evaluated pre treatment, at 1 day, 1 month, 3 month, 6 month. A.SIGNS: 1. Tenderness on palpation of the joint. 2. Tenderness in muscle of mastication. 3. Interincisal distance. 4. Protrusion. 5. Lateral excursion (right and left). 6. Deviation during jaw opening and closing. 7. Crepitus. B SYMPTOMS: 1. Pain on mouth opening. 2. Clicking sounds. 3. TMJ locking.

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Secondary

Measure	Time frame
II. RADIOLOGICAL ASSESSMENT: 1.OPG - Joint space, shape of condyle and glenoid fossa. 2. MRI - 2a-Position of condyle. 2b-Position of disk to condyle. 2c-Disc recapture. 2d-Joint Effusion. 3 JVA: 3 A -Clinical data- 1. Pain free opening. 2. Maximum unassisted opening. 3. Maximum assisted opening. 4. Lateral deviation. 3 B- JVA- 1. Total integral. 2. Integral more than 300. 3. Integral than 300. 4. Peak Amplitude. 5. Peak Frequency.Timepoint: II. RADIOLOGICAL ASSESSMENT: Pre treatment and at the end of 6 months . 1.OPG - Joint space, shape of condyle and glenoid fossa. 2. MRI - 2a-Position of condyle. 2b-Position of disk to condyle. 2c-Disc recapture. 2d-Joint Effusion. 3 JVA: 3 A-Clinical data- 1. Pain free opening. 2. Maximum unassisted opening. 3. Maximum assisted opening. 4. Lateral deviation. 3 B-JVA- 1. Total integral. 2. Integral more than 300. 3. Integral less than 300. 4. Peak Amplitude. 5. Peak Frequency.	—

Measure

Time frame

II. RADIOLOGICAL ASSESSMENT: 1.OPG - Joint space, shape of condyle and glenoid fossa. 2. MRI - 2a-Position of condyle. 2b-Position of disk to condyle. 2c-Disc recapture. 2d-Joint Effusion. 3 JVA: 3 A -Clinical data- 1. Pain free opening. 2. Maximum unassisted opening. 3. Maximum assisted opening. 4. Lateral deviation. 3 B- JVA- 1. Total integral. 2. Integral more than 300. 3. Integral than 300. 4. Peak Amplitude. 5. Peak Frequency.Timepoint: II. RADIOLOGICAL ASSESSMENT: Pre treatment and at the end of 6 months . 1.OPG - Joint space, shape of condyle and glenoid fossa. 2. MRI - 2a-Position of condyle. 2b-Position of disk to condyle. 2c-Disc recapture. 2d-Joint Effusion. 3 JVA: 3 A-Clinical data- 1. Pain free opening. 2. Maximum unassisted opening. 3. Maximum assisted opening. 4. Lateral deviation. 3 B-JVA- 1. Total integral. 2. Integral more than 300. 3. Integral less than 300. 4. Peak Amplitude. 5. Peak Frequency.

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Countries

India

Contacts

Public ContactDR NARAHARI RANGANATHA

RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL

madhumati_dr@rediffmail.com9844116475

Outcome results

None listed

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