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
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 21, 2005 | ||||||||
| Last Updated Date | February 17, 2009 | ||||||||
| Start Date ICMJE | April 2006 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
time and frequency of visually detected WSL (white spot lesions) [ Time Frame: 3 month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
time and frequency of visually detected WSL (white spot lesions) | ||||||||
| Change History | Complete list of historical versions of study NCT00268138 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Elmex Gel Efficacy in Preventing White Spot Lesions | ||||||||
| Official Title ICMJE | 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 Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Dental Caries | ||||||||
| Intervention ICMJE | Drug: elmex gel
elmex gel once a week
Other Name: fluoride |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 314 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 10 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany, Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00268138 | ||||||||
| Other Study ID Numbers ICMJE | 123456-HMO-CTIL | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr Meir Redlich, Hadassah | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Gaba International AG | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | December 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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