Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268138
Status:
UNKNOWN
Last Update Posted:
2009-02-18
First Post:
2005-12-21
Brief Title:
Elmex Gel Efficacy in Preventing White Spot Lesions
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
the objective of this phase IV study to establish the efficacy of elmex gel with a fluoride concentration of 125 compared with placebo by determining prevention of white spot lesions in patients wearing fixed orthodontic appliances
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None