K02.0 K05.0 K05.1 K03.6
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Patients before the start of a fixed orthodontic therapy using the buccal technique (in both dental arches) with a minimum expected treatment duration of 6 months at the examining orthodontist (no move, etc.) • Bonding of the brackets in the upper and lower arches on the same day (T0) • no previous or interrupted fixed orthodontic therapy • at least 15 permanent incisors, canines and premolars present or erupted in both dental arches (5-5) • At least 15 permanent anterior teeth and premolars in both dental arches are intended to be affixed with a bracket (=15 tooth surfaces / participant).
Exclusion criteria
Exclusion criteria: • Patients = 18 years (adults) • Pregnancy or breastfeeding • Application of a dental fluoride varnish or a sealer within the last 12 months • Changes in the enamel on the teeth (fluorosis, hypocalcification, etc.) • Fillings and restorations in buccal tooth surfaces (glued with brackets) • Syndrome patients and patients with limited oral hygiene skills or ability to properly conduct the study • Systemic, endocrine or oral diseases (diabetes, periodontitis, open oral wounds / ulcers, etc.), poor general condition • Alcohol / drug abuse, long-term medication / antisialoga / steroids or other drugs that affect saliva, biofilm or the tooth support system in the last 6 months • Local fluoride content in domestic drinking water> 0.2ppm F- • Allergy / intolerance to fluorides or the preparations used • Missing written declaration of consent • Patients who do not agree to comply with the study protocol (no additional fluoride intake / PZR, dental treatment in consultation with an orthodontist, oral hygiene behavior, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICDAS-II-INDEX - Measurement of the white spot / caries progression by clinical-visual assessment of the extent of the enamel demineralization / initial caries on the buccal tooth surfaces with a score (Likhert scale). Times: T-1, recruitment: Appointment at least 30 days before the start of fixed orthodontic therapy; T0, baseline: after bonding the brackets and removing excess bonding material; T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after 6 months of fixed therapy (in case of coincidence with the end of therapy BEFORE debonding); T3: immediately AFTER debonding ENAMEL DECALCIFICATION INDEX (EDI) - Measurement of the white spot / caries extension by visual assessment of the extent of the enamel demineralization using intraoral photo status recordings with a score (Likhert scale). Points in time: T0, baseline: after the brackets have been bonded and the excess plastic removed; T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after 6 months of fixed therapy (in case of coincidence with the end of therapy BEFORE debonding); T3: immediately AFTER debonding | — |
Secondary
| Measure | Time frame |
|---|---|
| MODIFIED PLAQUE INDEX ACCORDING TO SILNESS / LÖE (MPI) - clinical-visual assessment of the extent of plaque accumulation on the buccal tooth surfaces with a score (Likhert scale). Times: T-1, recruitment: Appointment at least 30 days before the start of fixed orthodontic therapy, at which the patient is selected as a potential study participant; T0, baseline: before teeth cleaning and brackets bonding (at the beginning of the session); T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after 6 months of fixed therapy; T3: immediately AFTER debonding GINGIVAL INDEX ACCORDING TO SILNESS / LÖE (1963) - clinical-visual assessment of the extent of gingivitis per gingival margin / tooth with a score (Likhert scale). Times: T-1, recruitment: Appointment at least 30 days before the start of fixed orthodontic therapy, at which the patient is selected as a potential study participant; T0, baseline: before teeth cleaning and brackets bonding (at the beginning of the session); T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after 6 months of fixed therapy; T3: immediately AFTER debonding | — |
Countries
Germany
Contacts
Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg