Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 314
- Locations
- 4
- Primary Endpoint
- time and frequency of visually detected WSL (white spot lesions)
Study Overview
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 wearing fixed orthodontic appliances.
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
time and frequency of visually detected WSL (white spot lesions)
Time Frame: 3 month
Secondary Outcomes
- mineral loss according to QLF readings(3 month)
- Frequency and chronoloy of WSL(3 month)