K02.0 K05.0 K05.1 K03.6
Conditions
Interventions
Group 1: Intervention 1: Instructions on home oral hygiene and nutrition
Intervention 2: study-independent fixed orthodontic therapy in buccal technique
Intervention 3: application of a placebo varnis
Sponsors
Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: • Patients before starting a fixed orthodontic therapy in buccal technique (in both dental arches) with a minimum expected treatment period of 6 months • Bonding of brackets in the upper and lower arch on the same day (T0) • no previous or paused fixed orthodontic therapy • all permanent incisors, canines and premolars in both arches are present or erupted (5-5) • All anterior teeth and premolars in both arches are intended to be fit with a bracket (20 tooth surfaces / participant).
Exclusion criteria
Exclusion criteria: • Patients = 18 years (adults) • Pregnancy or lactation • Application of a dental fluoride varnish or other caries-protective varnish preparations within the last 12 months • Patients with a low to moderate caries risk (corresponding to 4 assessment parameters) • Enamel changes (fluorosis, hypocalcification, etc.) • Fillings and restorations in buccal tooth surfaces (with bracket) • Syndrome patients and patients with reduced oral hygiene ability or ability to perform the study properly • systemic, endocrine or oral diseases (diabetes, periodontitis, open oral wounds / ulcers, etc.), poor general condition • alcohol / drug abuse, smoking (tobacco), long-term medications or antibiotics / antisialoga / steroids or other medicines affecting the saliva, biofilm or the tooth holding apparatus 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 consent • Patients who are not prepared to comply with the protocol (no additional fluoride / PZR, dental treatment in consultation with orthodontists, oral hygiene, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICDAS-II-INDEX - Measurement of 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 value (Likhert scale). Times: T-1, recruitment: appointment at least 30 days before the start of the fixed orthodontic therapy; T0, baseline: after bonding the brackets and removing the excess material; T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after six months of fixed therapy (in case of a coincidence with the therapy end before debonding); T3: immediately after debonding ENAMEL DECALCIFICATION INDEX (EDI) - Measurement of white-spot / caries-extension by visual assessment of the extent of enamel demineralization by means of intraoral images with a score value (Likhert scale). Times: T0, Baseline: after bonding the brackets and removing excess material; T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after six months of fixed therapy (in case of a coincidence with the therapy end before debonding); T3: immediately after debonding | — |
Secondary
| Measure | Time frame |
|---|---|
| MODIFIED PLAQUE INDEX ACCORDING TO SILNESS / LOE (MPI) - Clinical-visual assessment of the extent of plaque accumulation on the buccal tooth surfaces with a score value (Likhert scale). Timing: T-1, recruitment: appointment at least 30 days before the start of the orthodontic therapy, at which the patient is selected as a potential paticipant; T0, baseline: before cleaning the teeth and bonding of the brackets (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 / LOE (1963) - Clinical-visual assessment of the extent of gingivitis per gingival margin / tooth with a score value (Likhert scale). Timing: T-1, recruitment: appointment at least 30 days before the start of the orthodontic therapy, at which the patient is selected as a potential participant; T0, baseline: before cleaning the tooth and bonding the brackets (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
Public ContactChristian Kirschneck
Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg
Outcome results
None listed