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. 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
Gaba International AG
Information provided by:
Hadassah Medical Organization

December 21, 2005
December 22, 2005
February 18, 2009
April 2006
December 2010   (Final data collection date for primary outcome measure)
time and frequency of visually detected WSL (white spot lesions) [ Time Frame: 3 month ]
time and frequency of visually detected WSL (white spot lesions)
Complete list of historical versions of study NCT00268138 on Archive Site
  • mineral loss according to QLF readings [ Time Frame: 3 month ]
  • Frequency and chronoloy of WSL [ Time Frame: 3 month ]
  • mineral loss according to QLF readings
  • Frequency and chronoloy of WSL
Not Provided
Not Provided
Elmex Gel Efficacy in Preventing White Spot Lesions
Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel
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.

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

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Dental Caries
Drug: elmex gel
elmex gel once a week
Other Name: fluoride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years to 60 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Germany,   Israel
Not Provided
Not Provided
Dr Meir Redlich, Hadassah
Hadassah Medical Organization
Gaba International AG
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
Hadassah Medical Organization
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP