Dental Caries | Elmex Gel Efficacy in Preventing White Spot Lesions
Dental Caries research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:elmex gelelmex gel once a week
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: April 2006
Completed Date: December 2010
Phase: Phase 4
Primary Outcome: time and frequency of visually detected WSL (white spot lesions)
Secondary Outcome: mineral loss according to QLF readings
Study sponsors, principal investigator, and references
Principal Investigator: Meir Redlich, DMD PhD
Lead Sponsor: Hadassah Medical Organization
Collaborator: Gaba International AG