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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dental Caries | Drug: elmex gel | Phase 4 |
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 (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 |
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Drug: elmex gel
- time and frequency of visually detected WSL (white spot lesions) [ Time Frame: 3 month ]
- mineral loss according to QLF readings [ Time Frame: 3 month ]
- Frequency and chronoloy of WSL [ Time Frame: 3 month ]

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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

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