Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Medellín City - Full Text View

Sponsors and Collaborators:	CES University Colgate Palmolive
Information provided by:	CES University
ClinicalTrials.gov Identifier:	NCT00475618

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:

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.
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	Phase III

Drug Information available for: Fluoride Sodium fluoride Stannous fluoride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Metropolitan Area Sorrounded Medellín City. A Clinical Trial

Further study details as provided by 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. ]

Estimated Enrollment:	429
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2009

Show Detailed Description

Eligibility

Ages Eligible for Study:	29 Months to 41 Months
Genders Eligible for Study:	Both
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

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

Contacts

Contact: Alexandra Saldarriaga, Master´s

574- 444 05 55 ext 534

asaldarriaga@ces.edu.co

Sponsors and Collaborators

CES University

Colgate Palmolive

Investigators

Principal Investigator:

Alexandra Saldarriaga, Master´s

CES U niversity - Medellín Colombia

More Information

Study ID Numbers:	1-Mejia
Study First Received:	May 16, 2007
Last Updated:	June 19, 2007
ClinicalTrials.gov Identifier:	NCT00475618
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by CES University:

Early chilhood caries
Prevention
Fluoride varnish

fluoride toothpaste
non fluoride tooth paste
Professional cleaning

Study placed in the following topic categories:

Fluorides, Topical
Tooth Diseases
Stomatognathic Diseases
Fluorides
Dental Caries

Additional relevant MeSH terms:

Cariostatic Agents
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions
Tooth Demineralization

ClinicalTrials.gov processed this record on January 16, 2009