K07.4
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients 12 years of age or older who are in need of correction of malocclusion and meet all of the inclusion but none of the exclusion criteria listed below. Inclusion Criteria: Patients or legal guardian must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data will be collected, analysed, and published. Patients who are a minimum of 12 years of age, and who are looking for an orthodontic treatment.
Exclusion criteria
Exclusion criteria: Patients with inadequate oral hygiene, Patients with allergies or hypersensitivity to co-polyester or polyurethane, Active periodontitis, Severe systemic / metabolic disease, Intake of drugs interfering with bone metabolism, Nicotine intake (= 10 cigarettes / day), Alcohol or drug abuse , TMJ disorders, Caries has to be restored before treatment start, Sleeping disorders that do not allow for usage of aligners at night, Patients with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability, Pregnancy, Patients with dental implants, Patients that have the second molars not yet erupted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 months digital PAR score, or if shorter treatment at the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral health, PAR score at end of treatment, Patient reported outcome measures, such as speech impairment, comfort. | — |
Countries
Germany
Contacts
Poliklinik für Kieferorthopädie