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
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
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
NCT ID
NCT00475618
First Posted
May 16, 2007
Last Updated
May 29, 2012
Sponsor
CES University
Collaborators
Colgate Palmolive
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
Learn more about this trial
Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Medellín City
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