Elmex Gel Efficacy in Preventing White Spot Lesions - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 21, 2005

Last Updated Date

February 17, 2009

Start Date ^†

April 2006

Current Primary Outcome Measures ^†

time and frequency of visually detected WSL (white spot lesions) [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00268138 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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 ]

Original Secondary Outcome Measures ^†

mineral loss according to QLF readings
Frequency and chronoloy of WSL

Descriptive Information

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.

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

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Dental Caries

Intervention ^†

Drug: elmex gel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

314

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

10 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Andrea Engl, Dr.

++41614156056

a.engl@gaba.com

Location Countries ^†

Germany, Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00268138

Responsible Party

Dr Meir Redlich, Hadassah

Secondary IDs ^††

Study Sponsor ^†

Hadassah Medical Organization

Collaborators ^††

Gaba International AG

Investigators ^†

Principal Investigator:	Meir Redlich, DMD PhD	Hadassah Medical Center, Dept of Orthodontics
Principal Investigator:	Paul George Jost-Brinkmann, Prof	Charite - Berlin, Dept of Orthodontics, Center of Dentistry

Information Provided By

Hadassah Medical Organization

Verification Date

December 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.