Child Dental Health |
Dental Health, Child |
Clinical Trial: Elmex Gel Efficacy in Preventing White Spot Lesions
This study is not yet open for patient recruitment.
Verified by Hadassah Medical Organization December 2005
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Dental Caries | Drug: elmex gel | Phase IV |
MedlinePlus related topics: Tooth Disorders
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
Secondary Outcomes: mineral loss according to QLF readings; Frequency and chronoloy of WSL
Expected Total Enrollment: 157
Study start: April 2006; Expected completion: December 2009
Last follow-up: December 2009; Data entry closure: December 2009
157 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
Accepts Healthy Volunteers
Inclusion Criteria:
treatment plan: minimum of 10 teeth to be bonded labially al least 10 years old written declaration of informed consent -
Exclusion Criteria:
known allergy to components of test products handicapped patientss 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
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Location and Contact Information
Israel
Hadassah Medical Organization, Jerusalem, Israel, Jerusalem, 91120, Israel
Hadas Lemberg, Phd 00 972 2 6777572 lhadas@hadassah.org.il
meir redlich, DMD PhD, Principal Investigator
meir redlich, DMD PhD, Principal Investigator, Hadassah Medical Center
More Information
Last Updated: December 21, 2005
Record first received: December 21, 2005
ClinicalTrials.gov Identifier: NCT00268138
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10

Not Signed In -


