Trial | NCT00268138  Report issue

Title

Elmex Gel Efficacy in Preventing White Spot Lesions
Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    314
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 Started
Apr 30
2006
Primary Completion
Dec 31
2010
Anticipated
Study Completion
Dec 31
2010
Anticipated
Last Update
Feb 18
2009
Estimate

Drug elmex gel

elmex gel once a week

  • Other names: fluoride

Criteria 

Inclusion Criteria:

treatment plan: minimum of 10 teeth to be bonded labially at least 10 years old
written declaration of informed consent

Exclusion Criteria:

known allergy to components of test products
handicapped patients who have difficulties brushing their teeth
pathological desquamation changes
known pregnancy, breast feeding
eating disorders
disease that effect dental hard tissue
participation in another clinical trial either currently or within the lase 30 days
No Results Posted