Tooth; Lesion, White Spot Lesions
Conditions
Keywords
white spot lesion, initial caries, fluoride, amine fluoride, orthodontics, remineralization, brackets
Brief summary
The aim of this study is to monitor the effect of intraoral topical high fluoride application on the development of white spot lesions (WSL) after orthodontic treatment with multibracket appliances and to compare it to a placebo.
Interventions
DRUGelmex® gelée
1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical
DRUGnegative control (placebo)
0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical
Sponsors
PD Dr. Christian Heumann
Gaba International AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Healthy volunteers (≥11 years) scheduled for bracket removal * ≥ 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding
Exclusion criteria
* Known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study * Known hypersensitivity or allergy to placebo gel ingredients * Alterations in the teeth's enamel, e.g. hypoplasia, fluorosis * Any illness/condition potentially affecting the study outcome at investigator's discretion * Known pregnancy or breast feeding during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WSL-size change | 12 weeks | Changes in size of white spot lesions (WSL) at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WSL-brightness change | Baseline up to 24 weeks | Changes in WSL brightness value (%) |
| WSL index on all upper front teeth | Baseline up to 24 weeks | Modified white spot lesion index (Gorelick et al. 1982): 0: no white spot formation 1. slight white spot formation, thin rim 2. excessive white spot formation, thicker bands 3. white spot formation with cavitation |
| Caries activity | Baseline up to 24 weeks | Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007) |
| WSL-size change | Baseline up to 24 weeks | Changes in size of WSL over study time |
| Gingival bleeding index on all upper front teeth | Baseline up to 24 weeks | Gingival bleeding index (Ainamo and Bay 1975). The following scores will be used: (0) no bleeding (1) bleeding occurs |
| DMFT index: Dental health of all teeth | Baseline, 24 weeks | DMFT index according to Klein et al. (1938): Dental health of all teeth will be assessed with respect to decay (D), missing (M) or filling (F). The DMFT-Index will be calculated. |
| Plaque index (Silness and Löe 1964)on all upper front teeth | Baseline up to 24 weeks | The grades will be assessed visually on all upper front teeth using a standard dental probe. (0) no plaque on inspection and probing 1. thin plaque film on gingival margin, detectable only on probing 2. moderate plaque film along the gingival margin, visually detectable even without probing 3. a lot of plaque along the gingival margin, filling the interdental spaces |
Countries
Germany
Outcome results
None listed