Elmex Gel Efficacy in Preventing White Spot Lesions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Gaba International AG
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00268138
First received: December 21, 2005
Last updated: February 17, 2009
Last verified: December 2005

December 21, 2005
February 17, 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 ] [ Designated as safety issue: No ]
time and frequency of visually detected WSL (white spot lesions)
Complete list of historical versions of study NCT00268138 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
314
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
Both
10 Years to 60 Years
Yes
Contact: Andrea Engl, Dr. ++41614156056 a.engl@gaba.com
Germany,   Israel
 
NCT00268138
123456-HMO-CTIL
Yes
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