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
Recruitment status was Recruiting
Sponsor:
Hadassah Medical Organization
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
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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:
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:
Detailed Description:
-
Drug: elmex gel
elmex gel once a week
Other Name: fluoride
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 (Child, Adult) |
| 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
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 ClinicalTrials.gov identifier: NCT00268138
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
| 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 |
ClinicalTrials.gov processed this record on September 28, 2016