Dental DecayPhase 3NCT00475618
Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Medellín City
A Phase 3 study testing topical fluoride varnish application., professional cleaning and No fluoride toothpaste in people with Dental Decay, run by CES University.
Trial 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… Read more about this study
- Who is it for?
- Ages 29 to 41 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Decay
- What is being tested?
- topical fluoride varnish application., professional cleaning and No fluoride toothpaste
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- May 2007to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 41 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children since 2.5 and 3.5 years old
- Deciduous teeth complete formula
- They are part of Su Salud health Service Company
- Healthy chlildrens
Who cannot join
- children with any mental or fhisical incapacity
About this study
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:
- 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.
Read the 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.
- Conditions
- Dental Decay
- Being tested
- topical fluoride varnish application., professional cleaning, No fluoride toothpaste
- Keywords
- Early chilhood caries, Prevention, Fluoride varnish, fluoride toothpaste, non fluoride tooth paste, Professional cleaning
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical fluoride varnish application.Procedure or surgery
Vanish application every 6 months in all accesible tooth surfaces
professional cleaningProcedure or surgery
Daily use fluoride toothpaste 500 ppm.
No fluoride toothpasteProcedure or surgery
Daily use no fluoride toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Varnish | Experimental | Professional cleaning + education + fluoride vanish Receives: Procedure: topical fluoride varnish application. |
| Fluoride Toothpaste 500 ppm | Active comparator | Professional cleaning + education + fluoride toothpaste 500 ppm Receives: Procedure: professional cleaning |
| No fluoride toothpaste | Active comparator | Professional cleaning + education + no fluoride toothpaste Receives: Procedure: No fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Caries reduction as if the patient has or not new dental caries.
Measured: Three years with clinical examination every one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DecayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Principal investigator, Alexandra Saldarriaga Cadavid Ms, CES University
- Investigators
- Alexandra Saldarriaga, Master of Sience, Principal investigator, CES University - Medellín - Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475618
- Sponsor's protocol ID
- 1-Mejia
- Status last verified
- May 2012
- First submitted
- 16 May 2007
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Metropolitan Area Sorrounded Medellín City. A Clinical Trial
- ClinicalTrials.gov ID
- NCT00475618
- Acronym / sponsor ID
- 1-Mejia
- Conditions
- Dental Decay
- Keywords
- Early chilhood caries, Prevention, Fluoride varnish, fluoride toothpaste, non fluoride tooth paste, Professional cleaning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- May 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish | Experimental | Procedure: topical fluoride varnish application.Professional cleaning + education + fluoride vanish |
| Fluoride Toothpaste 500 ppm | Active comparator | Procedure: professional cleaningProfessional cleaning + education + fluoride toothpaste 500 ppm |
| No fluoride toothpaste | Active comparator | Procedure: No fluoride toothpasteProfessional cleaning + education + no fluoride toothpaste |
Who may qualify
- Ages
- 29 to 41 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children since 2.5 and 3.5 years old
- Deciduous teeth complete formula
- They are part of Su Salud health Service Company
- Healthy chlildrens
Key exclusion criteria (1 listed)
- children with any mental or fhisical incapacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical fluoride varnish application.Vanish application every 6 months in all accesible tooth surfaces | Procedure or surgery | Fluoride Varnish |
| professional cleaningDaily use fluoride toothpaste 500 ppm. | Procedure or surgery | Fluoride Toothpaste 500 ppm |
| No fluoride toothpasteDaily use no fluoride toothpaste. | Procedure or surgery | No fluoride toothpaste |
Primary outcome
Dental Caries reduction as if the patient has or not new dental caries.
Time frame: Three years with clinical examination every one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Saldarriaga, Master of Sience principal investigator
CES University - Medellín - Colombia
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topical fluoride varnish application., professional cleaning and No fluoride toothpaste in people with Dental Decay, run by CES University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Caries reduction as if the patient has or not new dental caries. (time frame: Three years with clinical examination every one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2012.