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Elmex Gel Efficacy in Preventing White Spot Lesions

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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
Sponsor:
Collaborator:
Gaba International AG
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE December 21, 2005
First Posted Date  ICMJE December 22, 2005
Last Update Posted Date February 18, 2009
Study Start Date  ICMJE April 2006
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2007)
time and frequency of visually detected WSL (white spot lesions) [ Time Frame: 3 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2005)
time and frequency of visually detected WSL (white spot lesions)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2007)
  • mineral loss according to QLF readings [ Time Frame: 3 month ]
  • Frequency and chronoloy of WSL [ Time Frame: 3 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2005)
  • mineral loss according to QLF readings
  • Frequency and chronoloy of WSL
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Elmex Gel Efficacy in Preventing White Spot Lesions
Official Title  ICMJE Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel
Brief Summary 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.
Detailed Description

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2006)
314
Original Enrollment  ICMJE
 (submitted: December 21, 2005)
157
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00268138
Other Study ID Numbers  ICMJE 123456-HMO-CTIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Meir Redlich, Hadassah
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Gaba International AG
Investigators  ICMJE
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
PRS Account Hadassah Medical Organization
Verification Date December 2005

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