NCT00268138

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
314

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 18, 2009

Status Verified

December 1, 2005

Enrollment Period

4.7 years

First QC Date

December 21, 2005

Last Update Submit

February 17, 2009

Conditions

Dental Caries

Keywords

amine fluoridewhite spot lesionsqlf

Outcome Measures

Primary Outcomes (1)

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

    3 month

Secondary Outcomes (2)

  • mineral loss according to QLF readings

    3 month

  • Frequency and chronoloy of WSL

    3 month

Interventions

elmex gelDRUG

elmex gel once a week

Also known as: fluoride

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • treatment plan: minimum of 10 teeth to be bonded labially at least 10 years old
  • written declaration of informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charite University

Berlin, D-13353, Germany

RECRUITING

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Fluorides

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Engl, Dr.

CONTACT

++41614156056a.engl@gaba.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 22, 2005

Study Start

April 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 18, 2009

Record last verified: 2005-12

Locations

IL(1)DE(1)