Malocclusion
Conditions
Interventions
Test group:wear clear invisible aligners
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Aged 12 to 50 years old (inclusive), in the permanent dentition stage, with no restriction on sex; 2. Retention of 24 teeth required (including natural teeth and dental restorations, but excluding dental implants); 3. Having clinical indications for orthodontic treatment, and willing to participate in and cooperate with the treatment; 4. Voluntary participation with signed informed consent; for minors, informed consent must be signed by the guardian, who shall exercise relevant rights on their behalf.
Exclusion criteria
Exclusion criteria: 1. Patients with progressive periodontitis, severe periodontitis, alveolar mucosal lesions, severe temporomandibular disorders, severe gingivitis, epilepsy, psychiatric disorders, coma, impaired consciousness, inability to perform activities of daily living, or unrealistic expectations for orthodontic treatment; 2. Patients with severe cardiovascular and cerebrovascular diseases, hepatic diseases, renal diseases, hematological diseases, endocrine diseases, pulmonary diseases, neurological diseases, tumors, diabetes mellitus, autoimmune diseases, chronic hepatitis, acquired immunodeficiency syndrome, or other systemic diseases that may affect orthodontic treatment; 3. Patients with relevant history of allergies, extensive allergic diathesis, known hypersensitivity to dental film/dental membrane materials; patients with significant foreign body sensation that cannot be overcome; 4. Patients who have received orthodontic treatment (e.g., dental correction, arch expansion) within the past 2 years; 5. Patients currently using or with long-term use of systemic corticosteroids or other immunomodulatory agents; 6. Patients with extensive tooth loss or severe dental tissue abrasion/loss; 7. Patients at risk of swallowing the clear invisible aligners; 8. Patients whose abutment tooth morphology is unsuitable for clear aligner wear; 9. Pregnant or lactating women, or those planning to conceive within 2 years; 10. Patients with abnormal occlusal function such as nocturnal bruxism or clenching; 11. Patients with special occupations who are assessed to be unable to meet aligner wearing requirements or have poor compliance, including occupations requiring respiratory equipment/oral protective gear, exposure to corrosive chemicals/high-temperature environments, frequent food tasting, special speech requirements, and long-term high-intensity work; 12. Patients who have participated in clinical trials of other orthodontic appliances or orthodontic-related materials within the past 3 months; 13. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tooth Movement Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Pain Score;Patient Quality of Life Score;Patient Satisfaction Assessment;Root Resorption;Gingival Index;Device Dislodgement;Device Deformation / Damage;Device Defect; | — |
Countries
China
Contacts
Public ContactYang Fan
Zhejiang Provincial People's Hospital
Outcome results
None listed