Elmex Gel Efficacy in Preventing White Spot Lesions

February 17, 2009 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

314

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andrea Engl, Dr.
  • Phone Number: ++41614156056
  • Email: a.engl@gaba.com

Study Locations

  • Germany
      • Berlin, Germany, D-13353
  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Organization, Jerusalem, Israel
        • Principal Investigator:
          • Meir Redlich, DMD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 58 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time and frequency of visually detected WSL (white spot lesions)
Time Frame: 3 month
3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
mineral loss according to QLF readings
Time Frame: 3 month
3 month
Frequency and chronoloy of WSL
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 21, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123456-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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