Elmex Gel Efficacy in Preventing White Spot Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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elmex gel

elmex gel once a week

Intervention Type DRUG

Other Intervention Names

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fluoride

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes