Elmex Gel Efficacy in Preventing White Spot Lesions
This study is currently recruiting patients
Verified by Hadassah Medical Organization December 2005
| Sponsors and Collaborators: |
Hadassah Medical Organization
Gaba International AG |
| Information provided by: |
Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: |
NCT00268138 |
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 IV
|
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Further study details as provided by Hadassah Medical Organization:
Primary Outcomes: time and frequency of visually detected WSL (white spot lesions)
Secondary Outcomes: mineral loss according to QLF readings; Frequency and chronoloy of WSL
Expected Total Enrollment:
314
Study start: April 2006;
Expected completion: December 2009
Last follow-up: December 2009;
Data entry closure: December 2009
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
-
60 Years,
Genders Eligible for Study:
Both
Accepts Healthy Volunteers
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
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00268138
GermanyCharite University, Berlin,
D-13353,
Germany; Recruiting
IsraelHadassah Medical Organization, Jerusalem, Israel, Jerusalem,
91120,
Israel; Recruiting
Study chairs or principal investigators
Meir Redlich, DMD PhD, Principal Investigator, Hadassah Medical Center, Dept of Orthodontics
Paul George Jost-Brinkmann, Prof, Principal Investigator, Charite - Berlin, Dept of Orthodontics, Center of Dentistry
More Information
Study ID Numbers:
123456-HMO-CTIL
Last Updated:
September 11, 2006
Record first received:
December 21, 2005
ClinicalTrials.gov Identifier:
NCT00268138Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-09-29
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