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Sponsors and Collaborators: |
Hadassah Medical Organization Gaba International AG |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00268138 |
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.
Condition | Intervention | Phase |
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Dental Caries |
Drug: elmex gel |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 314 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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
Ages Eligible for Study: | 10 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Engl, Dr. | ++41614156056 | a.engl@gaba.com |
Germany | |
Charite University | Recruiting |
Berlin, Germany, D-13353 | |
Contact: Paul-Georg Jost-Brinkmann, Prof ++4930450562532 paul-g.jost-brinkmann@charite.de | |
Israel | |
Hadassah Medical Organization, Jerusalem, Israel | Recruiting |
Jerusalem, Israel, 91120 | |
Contact: Arik tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il | |
Contact: Hadas Lemberg, Phd 00 972 2 6777572 lhadas@hadassah.org.il | |
Principal Investigator: Meir Redlich, DMD PhD |
Principal Investigator: | Meir Redlich, DMD PhD | Hadassah Medical Center, Dept of Orthodontics |
Principal Investigator: | Paul George Jost-Brinkmann, Prof | Charite - Berlin, Dept of Orthodontics, Center of Dentistry |
Responsible Party: | Hadassah ( Dr Meir Redlich ) |
Study ID Numbers: | 123456-HMO-CTIL |
Study First Received: | December 21, 2005 |
Last Updated: | June 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00268138 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
amine fluoride white spot lesions qlf |
Tooth Diseases Stomatognathic Diseases Fluorides Dental Caries |
Tooth Demineralization |