Elmex Gel Efficacy in Preventing White Spot Lesions

Hadassah Medical Center

Status and phase

Unknown

Phase 4

Conditions

Dental Caries

Treatments

Drug: elmex gel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00268138

123456-HMO-CTIL

Details and patient eligibility

About

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.

Full 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 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

Enrollment

314 estimated patients

Sex

All

Ages

10 to 60 years old

Volunteers

Accepts Healthy Volunteers

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