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

This study has been completed.
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Alexandra Saldarriaga Cadavid Ms, CES University
ClinicalTrials.gov Identifier:
NCT00475618
First received: May 16, 2007
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Dental Decay Procedure: topical fluoride varnish application. Procedure: professional cleaning Procedure: No fluoride toothpaste Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alexandra Saldarriaga Cadavid Ms, CES University:

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

Enrollment: 180
Study Start Date: May 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475618

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

Responsible Party: Alexandra Saldarriaga Cadavid Ms, Principal investigator, CES University
ClinicalTrials.gov Identifier: NCT00475618     History of Changes
Other Study ID Numbers: 1-Mejia
Study First Received: May 16, 2007
Last Updated: May 29, 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

ClinicalTrials.gov processed this record on September 21, 2017