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Occlusal Devices for Restriction of mandibular Movements associated with Temporomandibular joint dysfunction

Therapeutic effectiveness of RA.DI.CA. splint versus stabilization splint in subjects with temporomandibular joint closed lock

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN77777174
Enrollment
24
Registered
2022-08-01
Start date
2020-07-01
Completion date
Unknown
Last updated
2022-08-15

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

Conditions

Acute anterior disc displacement without reduction of temporomandibular joint Musculoskeletal Diseases

Interventions

Patients visiting the Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, within a period of 15 months (n = 330) and referring temporomandibular disorders, are screened by exp

Sponsors

Sapienza University of Rome
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old 2. Diagnosis of jaw functional limitation due to unilateral disc displacement without reduction for less than 6 months, verified in magnetic resonance imaging (MRI), according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and DC/TMD criteria

Exclusion criteria

Exclusion criteria: 1. Jaw limitation due to other factors such as connective tissue diseases (scleroderma), traumas (mandibular or condylar fractures), deformities, tumors, temporomandibular joint (TMJ) ankylosis, muscular locking 2. Other concomitant conservative therapies such as physical rehabilitation

Design outcomes

Primary

MeasureTime frame
1. Arthralgia, headache and neck pain evaluated using a Verbal Numeric Scale at baseline (T0), after 1 month (T1) and after 6 months (T2) 2. Functional excursions such as mouth opening measured with a gauge and expressed in mm at T0, T1 and T2

Secondary

MeasureTime frame
Evaluation of axis II (psychosocial component) through questionnaires provided by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) at T0 (baseline), at T1 (1 month after the beginning of therapy) and at T2 (6 months after the start of therapy)

Countries

Italy

Outcome results

None listed

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