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| Descriptive Information Fields | |||||||||
| Brief Title † | Elmex Gel Efficacy in Preventing White Spot Lesions | ||||||||
| 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 | ||||||||
| Brief Summary | 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. |
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| 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 |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | time and frequency of visually detected WSL (white spot lesions) [ Time Frame: 3 month ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Dental Caries | ||||||||
| Intervention † | Drug: elmex gel | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 314 | ||||||||
| Start Date † | April 2006 | ||||||||
| Completion Date | December 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 10 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | Germany, Israel | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00268138 | ||||||||
| Organization ID | 123456-HMO-CTIL | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Hadassah Medical Organization | ||||||||
| Collaborators †† | Gaba International AG | ||||||||
| Investigators † |
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| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | December 2005 | ||||||||
| First Received Date † | December 21, 2005 | ||||||||
| Last Updated Date | June 29, 2008 | ||||||||
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