To monitor the white spot lesion development and dental status under weekly applied 1.25% fluoride gel compared to placebo in patients after orthodontic treatment with multibracket appliances
Conditions
Sponsors
GABA International AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Healthy volunteers (= 11 years) scheduled for bracket removal • Multibracket appliance therapy in the upper jaw for at least one year • = 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding • WSL not present at start of orthodontic treatment (comparison with pre-treatment intraoral photographs). • No restorative or prosthetic therapy planned on UFT • Agreement of patient (for the whole study duration) not to use any oral hygiene products other than the ones received in this study (allowed in addition: oral irrigator, dental floss and interdental brushes) Are the trial subjects under 18? yes Number of subjects for this age range: 46 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • WSL with a modified score 3 (Gorelick et al. 1982) on UFT at debonding • Ongoing oral or dental treatment except emergency treatment • 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: Acid Yellow (E 104), Sunset Yellow (E 110), PEG-40 Hydrogenated Castor Oil, Methyl p-Hydroxybenzoate (Parabene E 218), Propyl p-Hydroxybenzoate (Parabene E 216) • Professional administration of highly concentrated fluoride products like gels, tablets, varnishes, fillings etc. within 30 days prior to enrolment • Professional administration or home-use of non-study related highly concentrated fluoride products like gels, tablets, varnishes, fillings etc. during the whole study • Alterations in the teeth’s enamel, e.g. hypoplasia, fluorosis • Chronic use of medication causing dry mouth • Known xerostomia • Medication for central nervous system conditions • Any illness/condition potentially affecting the study outcome at investigator’s discretion • Known pregnancy or breast feeding during the course of the study • Participation in a clinical trial or receipt of an investigational compound/treatment within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To monitor the effect of intraoral topical high fluoride application on the development of white spot lesions (WSL) after orthodontic treatment with multibracket appliances. Null hypothesis (H0): no difference between verum and placebo group Alternative hypothesis (H1): verum significantly different from placebo group Primary Study Parameter: Changes in size of white spot lesions (WSL) at 12 weeks (lesion size to total labial tooth area, %) ;Secondary Objective: - Changes in size of WSL over study time - Changes in the mean pixel brightness value of WSL (%) - Modified white spot lesion index (Gorelick et al. 1982) - Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007) - Plaque index (Silness and Löe 1964) - Gingival bleeding index (Ainamo & Bay 1975) - DMFT (Klein et al. 1938) Others: - Stimulated salivary flow rate - Saliva buffer capacity - Questionnaire - Safety ;Primary end point(s): The primary parameter is the difference in DWL%t from T0 to T4 (baseline to 12 weeks): ?DWL%t = DWL%t (12 weeks) – DWL%t (baseline) The white spot lesion area of the test group (elmex® gel) will be compared to the control group (placebo gel).;Timepoint(s) of evaluation of this end point: Jun. 2012 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary parameters are as follows: - SL size at T0, T1, T2, T3, T4, T5 - percentage of lesion size to total labial tooth (DWL%) at T0 - changes of WSL size (absolute) and change in percentage of lesion size to labial tooth (DWL%) from T0 to T1, T2, T3, T5 - mean pixel brightness value of WSL at T0, T1, T2, T3, T4, T5 - changes in the mean pixel brightness value of WSL(%) from T0 to T1, T2, T3, T4, T5 (relating always to the actual WSL-area) - changes in the mean pixel brightness value of WSL(%) from T0 to T1, T2, T3, T4, T5 (always relating to the baseline WSL-area) - modified white spot lesion index at all six appointments - changes of white spot lesion index from T0 to T1, T2, T3, T4, T5 - caries activity index (LAA) at all six appointments - changes of caries activity index from T0 to T1, T2, T3, T4, T5 - plaque index at all six appointments - changes of plaque index from T0 to T1, T2, T3, T4, T5 - gingival bleeding index at all six appointments - changes of gingival bleeding index from T0 to T1, T2, T3, T4, T5 - DMFT index at T0 and T5 - changes of DMFT index from T0 to T5 - stimulated salivary flow rate at T0, T4 and T5 - changes of stimulated salivary flow rate from T0 to T4, T5 - saliva buffer capacity at T0, T1, T4, T5 - changes of saliva buffer capacity from T0 to T1, T4, T5 ;Timepoint(s) of evaluation of this end point: Jun. 2012 | — |
Countries
Germany
Contacts
Public ContactScientific Affairs - GASAS-1002X
GABA International AG
Outcome results
None listed