Malocclusion Oral Health
Conditions
Interventions
Two groups of patients (male and female, aged 13-19 years) will be randomly allocated into one of two arms:
1. Group 1 will consist of 30 patients. All of these patients receive a traditional multi-br
Sponsors
Align Technology, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Orthodontic indication for a vestibular multi-bracket appliance or 2. The need and desire to receive Invisalign therapy 3. Persons aged 13-19 years (teenagers) with fully erupted and visible teeth before treatment 4. No white spot lesions at baseline/no caries 5. Good oral hygiene 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with cheilognathopalatoschisis or other syndromes associated with craniofacial abnormalities 2. Patients with enamel abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Macroscopic characterization (presence, frequency, and severity) of white spot lesions at baseline, after 6 months, and after 12 months of orthodontic treatment. The severity of disease will be rated according to Gorelick's classification: Grade 0: no visible white spot lesions on clinical investigation Grade 1: minor white spot lesions Grade 2: severe white spot lesions Grade 3: white spot lesions with cavitation 2. Determination of fluorescence, size and lesion depth and the bacterial acitivity of white spot lesions by means of quantitative light-induced fluorescence measurement (QLF) at baseline, after 6 months, and after 12 months of orthodontic treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of fluorescence, size and lesion depth and the bacterial activity of white spot lesions by means of quantitative light-induced fluorescence measurement (QLF) after active orthodontic treatment and 6 month later. | — |
Countries
Germany
Outcome results
None listed