Malocclusion
Conditions
Interventions
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1) Age Criteria 6-55 years (2) Diagnostic Inclusion Diagnosis of at least one of the following nine complex malocclusion types: a. Overjet b. Crossbite c. Deep overbite d. Bimaxillary protrusion e. Dental crowding f. Diastema g. Open bite h. Laterognathism i. Orthodontic management for cleft lip/palate (3) Good Compliance Requirements (4) Oral Health Criteria Optimal periodontal status: Bleeding on probing (BOP) <15% of sites Clinical attachment loss <= 2 mm Absence of: Gingival inflammation/edema Pathologic alveolar bone resorption Periapical lesions Maintained oral hygiene (5) Exclusion Criteria Systemic conditions affecting treatment outcomes: Uncontrolled hypertension Diabetes mellitus Cardiovascular diseases Autoimmune/immune system disorders Metabolic bone diseases
Exclusion criteria
Exclusion criteria: (1) Allergy-related Exclusions History of hypersensitivity reactions or atopic predisposition Documented allergy to polyurethane acrylate materials Persistent intolerance to foreign body sensation (VAS score >= 7/10) (2) Pharmacological Exclusions Chronic systemic corticosteroid use (>30 consecutive days) Immunomodulatory agent administration during study period or within one year preceding enrollment (3) Clinical Trial Participation Enrollment in other dental material clinical trials within three months prior to study participation (4) Protocol Non-compliance Risks Anticipated inability to adhere to follow-up schedules Potential compromise to scientific validity or data integrity (5) Systemic Disease Exclusions Active rheumatoid arthritis (DAS28 >3.2) Uncontrolled diabetes mellitus (HbA1c >8%) Osteoporosis (T-score 10 cigarettes/day) with refusal to cease use during study (8) Behavioral Exclusions Documented history of non-compliance with therapeutic protocols or follow-up requirements (9) Reproductive Status Exclusions Preconception planning phase Current pregnancy (ß-hCG confirmed) Lactation period (10) TMJ Disorder Exclusion Severe temporomandibular joint disorder syndrome (DC/TMD Criteria Grade III) (11) Discretionary Exclusion Other conditions deemed contraindicated by investigators based on: Clinical judgment Emerging safety data Unforeseen risk-benefit profile
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expression of orthodontic tooth movement;Real tooth movement amount;Predicted tooth movement amount; | — |
Secondary
| Measure | Time frame |
|---|---|
| Root resorption;Alveolar bone thickness;Gingival crevicular fluid detection;VAS score;Patient satisfaction assessment;Doctor satisfaction assessment; | — |
Countries
China
Contacts
Public ContactFang Bing
Department of Orthodontics, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Outcome results
None listed