Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Medellín City
1 other identifier
interventional
180
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2007
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 16, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 31, 2012
May 1, 2012
5 years
May 16, 2007
May 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dental Caries reduction as if the patient has or not new dental caries.
Three years with clinical examination every one year.
Study Arms (3)
Fluoride Varnish
EXPERIMENTALProfessional cleaning + education + fluoride vanish
Fluoride Toothpaste 500 ppm
ACTIVE COMPARATORProfessional cleaning + education + fluoride toothpaste 500 ppm
No fluoride toothpaste
ACTIVE COMPARATORProfessional cleaning + education + no fluoride toothpaste
Interventions
Vanish application every 6 months in all accesible tooth surfaces
Eligibility Criteria
You may qualify if:
- Children since 2.5 and 3.5 years old
- Deciduous teeth complete formula
- They are part of Su Salud health Service Company
- Healthy chlildrens
You may not qualify if:
- children with any mental or fhisical incapacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CES Universitylead
- Colgate Palmolivecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandra Saldarriaga, Master of Sience
CES University - Medellín - Colombia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 16, 2007
First Posted
May 21, 2007
Study Start
May 1, 2007
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 31, 2012
Record last verified: 2012-05