Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Medellín City
Condition: Dental Decay
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): topical fluoride varnish application.; professional cleaning; No fluoride toothpaste
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Vanish application every 6 months in all accesible tooth surfaces; Daily use fluoride toothpaste 500 ppm.; Daily use no fluoride toothpaste.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Early chilhood caries; Prevention; Fluoride varnish; fluoride toothpaste; non fluoride tooth paste; Professional cleaning