Elmex Gel Efficacy in Preventing White Spot Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00268138|
Recruitment Status : Unknown
Verified December 2005 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : December 22, 2005
Last Update Posted : February 18, 2009
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Drug: elmex gel||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||314 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2006|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
Drug: elmex gel
- time and frequency of visually detected WSL (white spot lesions) [ Time Frame: 3 month ]
- mineral loss according to QLF readings [ Time Frame: 3 month ]
- Frequency and chronoloy of WSL [ Time Frame: 3 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|