the objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride concentration of 1.25% compared with placebo by determining prevention of white spot lesions in patients wearing fixed orthodontic appliances.
314 healthy subjects undergoing orthodontic treatment will be examined. follow up will take place from bonding the appliance till debonding, at least 12 months and no more than 30 months. tooth brushing with product (test product or control) once per week during the entire study. 4 times a year additional tray application of test product or control. subjects wiil clean their teeth with the toothpaste they usually use during the entire study. toothbrush and a sandglass will be provided every 6 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
314
elmex gel once a week
Charite University
Berlin, Germany
RECRUITINGHadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
RECRUITINGtime and frequency of visually detected WSL (white spot lesions)
Time frame: 3 month
mineral loss according to QLF readings
Time frame: 3 month
Frequency and chronoloy of WSL
Time frame: 3 month
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