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

Primary Purpose

Dental Decay

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
topical fluoride varnish application.
professional cleaning
No fluoride toothpaste
Sponsored by
CES University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Decay focused on measuring Early chilhood caries, Prevention, Fluoride varnish, fluoride toothpaste, non fluoride tooth paste, Professional cleaning

Eligibility Criteria

29 Months - 41 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Fluoride Varnish

    Fluoride Toothpaste 500 ppm

    No fluoride toothpaste

    Arm Description

    Professional cleaning + education + fluoride vanish

    Professional cleaning + education + fluoride toothpaste 500 ppm

    Professional cleaning + education + no fluoride toothpaste

    Outcomes

    Primary Outcome Measures

    Dental Caries reduction as if the patient has or not new dental caries.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 16, 2007
    Last Updated
    May 29, 2012
    Sponsor
    CES University
    Collaborators
    Colgate Palmolive
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00475618
    Brief Title
    Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Medellín City
    Official Title
    Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Metropolitan Area Sorrounded Medellín City. A Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    May 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CES University
    Collaborators
    Colgate Palmolive

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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: 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.
    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: Group A: Dental health education with brush and 500 PPM fluoride tooth paste; with professional cleaning each 6 months. Group B: Dental health education with brush and non fluoride tooth paste; with professional cleaning each 6 months. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Decay
    Keywords
    Early chilhood caries, Prevention, Fluoride varnish, fluoride toothpaste, non fluoride tooth paste, Professional cleaning

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluoride Varnish
    Arm Type
    Experimental
    Arm Description
    Professional cleaning + education + fluoride vanish
    Arm Title
    Fluoride Toothpaste 500 ppm
    Arm Type
    Active Comparator
    Arm Description
    Professional cleaning + education + fluoride toothpaste 500 ppm
    Arm Title
    No fluoride toothpaste
    Arm Type
    Active Comparator
    Arm Description
    Professional cleaning + education + no fluoride toothpaste
    Intervention Type
    Procedure
    Intervention Name(s)
    topical fluoride varnish application.
    Intervention Description
    Vanish application every 6 months in all accesible tooth surfaces
    Intervention Type
    Procedure
    Intervention Name(s)
    professional cleaning
    Intervention Description
    Daily use fluoride toothpaste 500 ppm.
    Intervention Type
    Procedure
    Intervention Name(s)
    No fluoride toothpaste
    Intervention Description
    Daily use no fluoride toothpaste.
    Primary Outcome Measure Information:
    Title
    Dental Caries reduction as if the patient has or not new dental caries.
    Time Frame
    Three years with clinical examination every one year.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    29 Months
    Maximum Age & Unit of Time
    41 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexandra Saldarriaga, Master of Sience
    Organizational Affiliation
    CES University - Medellín - Colombia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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