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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
History of Changes
  Purpose

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 Intervention Phase
Dental Caries
 Drug: elmex gel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • time and frequency of visually detected WSL (white spot lesions) [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 314
Study Start Date: April 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: elmex gel
    elmex gel once a week
    Other Name: fluoride
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

  Eligibility

Ages Eligible for Study:   10 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Meir Redlich, Hadassah
ClinicalTrials.gov Identifier: NCT00268138     History of Changes
Other Study ID Numbers: 123456-HMO-CTIL
Study First Received: December 21, 2005
Last Updated: February 17, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013