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Elmex Gel Efficacy in Preventing White Spot Lesions

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Gaba International AG
Information provided by:
Hadassah Medical Organization Identifier:
First received: December 21, 2005
Last updated: February 17, 2009
Last verified: December 2005
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

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 ]

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

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00268138

Contact: Andrea Engl, Dr. ++41614156056

Charite University Recruiting
Berlin, Germany, D-13353
Contact: Paul-Georg Jost-Brinkmann, Prof    ++4930450562532   
Hadassah Medical Organization, Jerusalem, Israel Recruiting
Jerusalem, Israel, 91120
Contact: Arik tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, Phd    00 972 2 6777572   
Principal Investigator: Meir Redlich, DMD PhD         
Sponsors and Collaborators
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
  More Information

Responsible Party: Dr Meir Redlich, Hadassah Identifier: NCT00268138     History of Changes
Other Study ID Numbers: 123456-HMO-CTIL
Study First Received: December 21, 2005
Last Updated: February 17, 2009

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

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs processed this record on April 27, 2017