Status:
UNKNOWN
Elmex Gel Efficacy in Preventing White Spot Lesions
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Gaba International AG
Conditions:
Dental Caries
Eligibility:
All Genders
10-60 years
Phase:
PHASE4
Brief Summary
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 we...
Detailed Description
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 brush...
Eligibility Criteria
Inclusion
- treatment plan: minimum of 10 teeth to be bonded labially at least 10 years old
- written declaration of informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT00268138
Start Date
April 1 2006
End Date
December 1 2010
Last Update
February 18 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Charite University
Berlin, Germany, D-13353
2
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel, 91120