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A randomized controlled trial of digital occlusal splints for the treatment of temporomandibular joint osteoarthritis

A randomized controlled trial of digital occlusal splints for the treatment of temporomandibular joint osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124073
Enrollment
Unknown
Registered
2026-05-07
Start date
2026-05-10
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Temporomandibular joint osteoarthritis

Interventions

Modified digital occlusal splint group:Modified digital occlusal splint treatment worn at night for 6 months, combined with oral glucosamine hydrochloride 1500 mg/day for 3 months and health education
Conventional digital occlusal splint group:Conventional digital occlusal splint treatment worn at night for 6 months, combined with oral glucosamine hydrochloride 1500 mg/day for 3 months and health e
Glucosamine-only group:Oral glucosamine hydrochloride alone at 1500 mg/day for 3 months, combined with health education.

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 years or older; 2. Diagnosed with temporomandibular joint osteoarthritis (TMJOA) using DC/TMD diagnostic criteria and temporomandibular joint CBCT imaging examination; 3. Have not received any treatment related to temporomandibular joint disorders in the past 3 months; 4. Able to understand the study content, voluntarily participate in this study, and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of orthodontic treatment or orthognathic surgery; 2. Presence of severe periodontal disease affecting >=3 teeth; 3. History of cleft lip and palate or other diseases affecting craniofacial growth and development; 4. Suffering from rheumatoid arthritis or other systemic diseases; 5. Having psychological or psychiatric disorders that may affect study compliance or outcome evaluation; 6. Women who are planning pregnancy or are pregnant; 7. Refusal to participate in this study or inability to complete follow-up according to the study protocol.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale pain score;

Secondary

MeasureTime frame
Maximum mouth opening;

Countries

China

Contacts

Public ContactXiao Cen

West China Hospital of Stomatology, Sichuan University

cenx@scu.edu.cn+86 152 0828 9630

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026