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Clinical randomized controlled study on the effects of digital SIP splint on masticatory muscle pain

Clinical randomized controlled study on the effects of digital SIP splint on masticatory muscle pain

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032699
Enrollment
Unknown
Registered
2020-05-07
Start date
2021-09-01
Completion date
Unknown
Last updated
2021-06-22

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

Conditions

Myalgia

Interventions

1:SIP splint
2:Michigan splint

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-40 years; 2. Patients with masticatory muscle pain (myalgia) were diagnosed by dc-tmd; 3. Patients with mild or moderate NRS pain score; 4. Subjects with PPT less than 1 KGF.

Exclusion criteria

Exclusion criteria: 1. Patients with severe chronic periodontal disease; 2. Patients with extensive caries (more than 5 teeth caries); 3. The patients with mouth opening limitation and joint pain caused by acute temporomandibular joint hinge; 4. Patients who need joint replacement and orthognathic surgery due to severe condylar absorption; 5. Patients with history of maxillofacial trauma; 6. Patients with severe maxillofacial infection; 7. Patients with craniofacial syndrome; 8. Patients with rheumatoid arthritis, diabetes, osteoporosis and other serious systemic diseases; 9. Patients who can not complete treatment and follow-up.

Design outcomes

Primary

MeasureTime frame
Pain intensity;Pain sensitivity;

Secondary

MeasureTime frame
Adverse events;

Countries

China

Contacts

Public ContactNing Zhao

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

zhaon1995@126.com+86 13661729690

Outcome results

None listed

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