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Elmex Gel Efficacy in Preventing White Spot Lesions

Primary Purpose

Dental Caries

Status

Unknown status

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

elmex gel

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring amine fluoride, white spot lesions, qlf

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Charite UniversityRecruiting
Hadassah Medical Organization, Jerusalem, IsraelRecruiting

Outcomes

Primary Outcome Measures

time and frequency of visually detected WSL (white spot lesions)

Secondary Outcome Measures

mineral loss according to QLF readings

Frequency and chronoloy of WSL

Full Information

NCT ID

NCT00268138

First Posted

December 21, 2005

Last Updated

February 17, 2009

Sponsor

Hadassah Medical Organization

Collaborators

Gaba International AG

1. Study Identification

Unique Protocol Identification Number

NCT00268138

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2005

Overall Recruitment Status

Unknown status

Study Start Date

April 2006 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

Collaborators

Gaba International AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

amine fluoride, white spot lesions, qlf

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

314 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

elmex gel

Other Intervention Name(s)

fluoride

Intervention Description

elmex gel once a week

Primary Outcome Measure Information:

Title

time and frequency of visually detected WSL (white spot lesions)

Time Frame

3 month

Secondary Outcome Measure Information:

Title

mineral loss according to QLF readings

Time Frame

3 month

Title

Frequency and chronoloy of WSL

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Engl, Dr.

Phone

++41614156056

a.engl@gaba.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meir Redlich, DMD PhD

Organizational Affiliation

Hadassah Medical Center, Dept of Orthodontics

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paul George Jost-Brinkmann, Prof

Organizational Affiliation

Charite - Berlin, Dept of Orthodontics, Center of Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charite University

City

Berlin

ZIP/Postal Code

D-13353

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul-Georg Jost-Brinkmann, Prof

Phone

++4930450562532

paul-g.jost-brinkmann@charite.de

Facility Name

Hadassah Medical Organization, Jerusalem, Israel

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arik tzukert, DMD

Phone

00 972 2 6776095

arik@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Hadas Lemberg, Phd

Phone

00 972 2 6777572

lhadas@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Meir Redlich, DMD PhD

12. IPD Sharing Statement

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Elmex Gel Efficacy in Preventing White Spot Lesions

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