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NCT00268138 Clinical Trial

Elmex Gel Efficacy in Preventing White Spot Lesions

Dental Caries Clinical Trial

Official title:
Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00268138
Other study ID # 123456-HMO-CTIL
Secondary ID
Status Recruiting
Phase Phase 4
First received December 21, 2005
Last updated February 17, 2009
Start date April 2006
Est. completion date December 2010

Study information
Verified date December 2005
Source Hadassah Medical Organization
Contact Andrea Engl, Dr.
Phone ++41614156056
Email a.engl@gaba.com
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 314
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• elmex gel
elmex gel once a week

Locations
Country Name City State
Germany Charite University Berlin
Israel Hadassah Medical Organization, Jerusalem, Israel Jerusalem

Sponsors (2)
Lead Sponsor Collaborator
Hadassah Medical Organization Gaba International AG

Countries where clinical trial is conducted

Germany,  Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary time and frequency of visually detected WSL (white spot lesions) 3 month No
Secondary mineral loss according to QLF readings 3 month No
Secondary Frequency and chronoloy of WSL 3 month No
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