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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?

Dental Caries

Study Interventions

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

Study Arms

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.

Study Status

Unknown status

Start Date: April 2006

Completed Date: December 2010

Phase: Phase 4

Type: Interventional

Design:

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

More information:https://clinicaltrials.gov/show/NCT00268138

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