Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients

Study Overview
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Brief Summary
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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.

Official Title
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White Spot Lesion Development in Post-orthodontic Patients Following Weekly Application of a 1.25% Fluoride Gel Compared to Placebo Over 6 Months

Conditions
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Tooth; Lesion, White Spot Lesions

Intervention / Treatment
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* Drug: elmex® gelée
* Drug: negative control (placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test<br>1.25% fluoride (elmex® gelée) | Drug: elmex® gelée<br>* 1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical<br>* Other names: elmex® gel;|
| Placebo Comparator: Control<br>0% fluoride (negative control) | Drug: negative control (placebo)<br>* 0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WSL-size change | Changes in size of white spot lesions (WSL) at 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WSL-size change | Changes in size of WSL over study time | Baseline up to 24 weeks | 
| WSL-brightness change | Changes in WSL brightness value (%) | Baseline up to 24 weeks | 
| WSL index on all upper front teeth | Modified white spot lesion index (Gorelick et al. 1982): 0: no white spot formation slight white spot formation, thin rim excessive white spot formation, thicker bands white spot formation with cavitation | Baseline up to 24 weeks | 
| Caries activity | Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007) | Baseline up to 24 weeks | 
| Plaque index (Silness and Löe 1964)on all upper front teeth | The grades will be assessed visually on all upper front teeth using a standard dental probe. (0) no plaque on inspection and probing thin plaque film on gingival margin, detectable only on probing moderate plaque film along the gingival margin, visually detectable even without probing a lot of plaque along the gingival margin, filling the interdental spaces | Baseline up to 24 weeks | 
| Gingival bleeding index on all upper front teeth | Gingival bleeding index (Ainamo and Bay 1975). The following scores will be used: (0) no bleeding (1) bleeding occurs | Baseline up to 24 weeks | 
| DMFT index: Dental health of all teeth | 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. | Baseline, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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white spot lesion, initial caries, fluoride, amine fluoride, orthodontics, remineralization, brackets