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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: elmex gel Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : April 2006
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes Tooth Decay
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Drug: elmex gel
    elmex gel once a week
    Other Name: fluoride

Outcome Measures
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Primary Outcome Measures :
  1. time and frequency of visually detected WSL (white spot lesions) [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. mineral loss according to QLF readings [ Time Frame: 3 month ]
  2. Frequency and chronoloy of WSL [ Time Frame: 3 month ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: Andrea Engl, Dr. ++41614156056 a.engl@gaba.com

Locations
Germany
Charite University Recruiting
Berlin, Germany, D-13353
Contact: Paul-Georg Jost-Brinkmann, Prof    ++4930450562532    paul-g.jost-brinkmann@charite.de   
Israel
Hadassah Medical Organization, Jerusalem, Israel Recruiting
Jerusalem, Israel, 91120
Contact: Arik tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, Phd    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Meir Redlich, DMD PhD         
Sponsors and Collaborators
Hadassah Medical Organization
Gaba International AG
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr Meir Redlich, Hadassah
ClinicalTrials.gov Identifier: NCT00268138     History of Changes
Other Study ID Numbers: 123456-HMO-CTIL
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: December 2005

Keywords provided by Hadassah Medical Organization:
amine fluoride
white spot lesions
qlf

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
 Olaflur
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs