Dental Decay Clinical Trial
Official title:
Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Metropolitan Area Sorrounded Medellín City. A Clinical Trial
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.
Dental caries is a public health problem in any society. Even though caries prevalence has
decreased in many industrialized countries, dental caries in the early infancy still has
high prevalence in non developing countries. In Colombia as well Medellín, there are not
data of dental caries prevalence in children under 5 years old.
The fact that the official studies do not recognize this world tendency and are limited to
age groups over 5 years old, underestimate the disease as an early appearing process in
life, specially in underprivileged groups. When dental caries is not properly treated, it
becomes a risk factor for other systemic and infectious diseases. Early infant dental caries
has been strongly related with malnutrition in children under 6 years old; is has been
proved that once their dental problem is treated, weight and size are recovered.
Design and implementation of prevention programs for preschool children must be a
priority.This study pretends evaluate some combined preventive measures of easy application
in children under 6 as education, brush teeth, fluoride free and fluoridated tooth paste,
professional cleaning and fluoride varnish application considering this an easy application
measure for this group of age, which eventually it could be more cost-effective than the
sealant.
The importance of doing new clinical studies to evaluate the efficacy of fluoride varnishes
combined with other preventive measures, is supported in most of other studies have used a
non treated group or placebo as a control group.12 The evaluation of the non fluoride
toothpaste will give us an exact idea of the contribution of each of the preventive measures
in dental caries reduction.
In Colombia, there is not doubt that past preventive programs had a positive effect in
dental health of school children. However, preschool children have been out of these
programs.
New programs should be carried on to educational establishment and infant care centres
without distinction of the type of social health insurance or coverage.
The study pretends to evaluate the efficacy of therapeutics measures like fluoride varnish
application and professional cleaning, which are characterized for their low cost and easy
application. In the first place, parents and children in the study will receive education
lecture, they will be provided with tooth brush and toothpaste with or without fluoride
depending the group assigned. At the same time the study pretends to generate knowledge that
contributes to minimize invasive and painful treatments in this group of age.
What effect has the inclusion of fluoride varnish and 500 ppm fluoridated toothpaste as
preventive measures complementary to oral health education and professional tooth cleaning
in reduction of dental caries in children under 5 years old?
Comparisons and Study group design: three groups will be randomly assigned to an
experimental group:
1. Group A: Dental health education with brush and 500 PPM fluoride tooth paste; with
professional cleaning each 6 months.
2. Group B: Dental health education with brush and non fluoride tooth paste; with
professional cleaning each 6 months.
3. Group C: Dental health education with brush and non fluoride tooth paste; with
professional cleaning each 6 months and topical fluoride varnish application.
The study will be a random controlled double blind assay made in children with primary
dentition and 2.5 or 3.5 years old at the beginning, from socio-economic status 2 and 3 that
are attended in Su Salud IPS ( Service lender institution) at the Metropolitan area of
Medellín city with 3 years follow-up.
A second part of the study pretends to measure presence of dental fluorosis in the permanent
dentition of the children that took part in the first assay. This proposal will be designed
in that moment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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