Elmex Gel Efficacy in Preventing White Spot Lesions - Full Text View

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

ChemIDplus related topics:

Fluoride Sodium fluoride Stannous fluoride Elmex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), 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 Outcome Measures:

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

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 ]

Estimated Enrollment:	314
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

elmex gel once a week

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

Eligibility

Ages Eligible for Study:	10 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268138

Contacts


Contact: Andrea Engl, Dr.	++41614156056	a.engl@gaba.com

Locations


Germany
	Charite University	Recruiting
	Berlin, Germany, D-13353
	Contact: Paul-Georg Jost-Brinkmann, Prof ++4930450562532 paul-g.jost-brinkmann@charite.de

Israel
	Hadassah Medical Organization, Jerusalem, Israel	Recruiting
	Jerusalem, Israel, 91120
	Contact: Arik tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
	Contact: Hadas Lemberg, Phd 00 972 2 6777572 lhadas@hadassah.org.il
	Principal Investigator: Meir Redlich, DMD PhD

Sponsors and Collaborators

Hadassah Medical Organization

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

More Information

Responsible Party:	Hadassah ( Dr Meir Redlich )
Study ID Numbers:	123456-HMO-CTIL
First Received:	December 21, 2005
Last Updated:	June 29, 2008
ClinicalTrials.gov Identifier:	NCT00268138
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

amine fluoride

white spot lesions

qlf

Study placed in the following topic categories:

Tooth Diseases

Stomatognathic Diseases

Fluorides

Dental Caries

Additional relevant MeSH terms:

Tooth Demineralization

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Hadassah Medical Organization Gaba International AG
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00268138