Temporomandibular joint disorder
Conditions
Interventions
Experimental group:customized digital occlusal splint
Control group:soft occlusal pad
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School Of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years old, gender is not limited; 2. According to the 2014 DC/TMD diagnostic criteria and MRI examination, diagnosed as temporomandibular joint disorder syndrome (TMD), and meet any of the following conditions: (1) VAS self-assessment >= 3.0 points; (2) Maximum mouth opening <= 30 mm; (3) There is joint snapping that affects the quality of life (score = 6 points); (4) Participate in the experiment voluntarily, have good compliance, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have received other drug injections or invasive operations in the joint area within the past 3 months; 2. Definitely diagnosed as rheumatoid arthritis, traumatic arthritis, suppurative arthritis, joint cyst, joint tumor; 3. Clearly diagnosed as pain caused by exogenous diseases, such as ear diseases, cervical spondylosis, etc.; 4. Those who suffer from mental illness and cannot understand the informed consent form; 5. Pregnant and lactating women; 6. Those who are known to be allergic to polymer materials; 7. Alcoholism or serious drug abusers; 8. Those who are participating in other clinical trials; 9. The researchers think that other reasons are not suitable for participating in clinical trials, such as: severely limited mouth opening, unable to wear occlusal pads or test equipment, oral infection, oropharyngeal sensitivity, severe periodontal disease, dentition defect or Missing, carious, residual roots, residual crowns or those who have worn orthodontic appliances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| visual analogue scale;Maximum opening degree;Joint snapping;Quality of life score;Satisfaction evaluation;Device defects;Complications/Adverse Events;serious adverse event; | — |
Countries
China
Contacts
Public ContactDongmei He
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School Of Medicine
Outcome results
None listed