Elmex Gel Efficacy in Preventing White Spot Lesions
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- time and frequency of visually detected WSL (white spot lesions) [ Time Frame: 3 month ] [ Designated as safety issue: No ]
- mineral loss according to QLF readings [ Time Frame: 3 month ] [ Designated as safety issue: No ]
- Frequency and chronoloy of WSL [ Time Frame: 3 month ] [ Designated as safety issue: No ]
|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)|
Drug: elmex gel
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268138
|Contact: Andrea Engl, Dr.||++firstname.lastname@example.org|
|Berlin, Germany, D-13353|
|Contact: Paul-Georg Jost-Brinkmann, Prof ++4930450562532 email@example.com|
|Hadassah Medical Organization, Jerusalem, Israel||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Arik tzukert, DMD 00 972 2 6776095 firstname.lastname@example.org|
|Contact: Hadas Lemberg, Phd 00 972 2 6777572 email@example.com|
|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|