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Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Medellín City

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ClinicalTrials.gov Identifier: NCT00475618
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : May 31, 2012
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Alexandra Saldarriaga Cadavid Ms, CES University

Brief Summary:

The propouse of this study is to evaluate some combined preventive measures, of easy application in children under 6 years old as education, brush teeth, fluoride free tooth paste,fluoridated tooth paste, professional cleaning and fluoride varnish application, to determine between three groups of differents combined preventive measures, wich one is better in reduting dental caries appearance.

Hypothesis:

  1. Ho: Dental caries reduction percentage is larger or equal in the group with only prevention education and Professional cleaning, than in the groups intercepted with fluoride varnish or fluoride toothpaste.
  2. Ha: Dental caries reduction percentage is less in the group with only prevention education and Professional cleaning, than in the groups intercepted with fluoride varnish or fluoride toothpaste.

Condition or disease Intervention/treatment Phase
Dental Decay Procedure: topical fluoride varnish application. Procedure: professional cleaning Procedure: No fluoride toothpaste Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Metropolitan Area Sorrounded Medellín City. A Clinical Trial
Study Start Date : May 2007
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Fluoride Varnish
Professional cleaning + education + fluoride vanish
Procedure: topical fluoride varnish application.
Vanish application every 6 months in all accesible tooth surfaces

Active Comparator: Fluoride Toothpaste 500 ppm
Professional cleaning + education + fluoride toothpaste 500 ppm
Procedure: professional cleaning
Daily use fluoride toothpaste 500 ppm.

Active Comparator: No fluoride toothpaste
Professional cleaning + education + no fluoride toothpaste
Procedure: No fluoride toothpaste
Daily use no fluoride toothpaste.




Primary Outcome Measures :
  1. Dental Caries reduction as if the patient has or not new dental caries. [ Time Frame: Three years with clinical examination every one year. ]


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Ages Eligible for Study:   29 Months to 41 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children since 2.5 and 3.5 years old
  • Deciduous teeth complete formula
  • They are part of Su Salud health Service Company
  • Healthy chlildrens

Exclusion Criteria:

  • children with any mental or fhisical incapacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475618


Sponsors and Collaborators
CES University
Colgate Palmolive
Investigators
Principal Investigator: Alexandra Saldarriaga, Master of Sience CES University - Medellín - Colombia

Responsible Party: Alexandra Saldarriaga Cadavid Ms, Principal investigator, CES University
ClinicalTrials.gov Identifier: NCT00475618     History of Changes
Other Study ID Numbers: 1-Mejia
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: May 2012

Keywords provided by Alexandra Saldarriaga Cadavid Ms, CES University:
Early chilhood caries
Prevention
Fluoride varnish
fluoride toothpaste
non fluoride tooth paste
Professional cleaning

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs