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Dental Research Programs in Jerusalem Israel


Elmex Gel Efficacy in Preventing White Spot Lesions

This study is currently recruiting patients

Verified by Hadassah Medical Organization December 2005

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


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

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

Further study details as provided by Hadassah Medical Organization:
Primary Outcomes: time and frequency of visually detected WSL (white spot lesions)
Secondary Outcomes: mineral loss according to QLF readings; Frequency and chronoloy of WSL
Expected Total Enrollment:  314

Study start: April 2006;  Expected completion: December 2009
Last follow-up: December 2009;  Data entry closure: December 2009

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   -   60 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00268138

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

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

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

Study chairs or principal investigators

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

More Information

Study ID Numbers:  123456-HMO-CTIL
Last Updated:  September 11, 2006
Record first received:  December 21, 2005
ClinicalTrials.gov Identifier:  NCT00268138
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-09-29





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