Dental CariesCZCNCT02578966
Cohort Zero Caries
A study testing Motivational Interview and Traditional health education in people with Dental Caries and Early Childhood Caries, run by Hospital Nossa Senhora da Conceicao.
Trial summary
The purpose of this study is to compare the effectiveness of a traditional oral health educational program and a program based on the theories of the Motivational Interview directed to the child's mothers/fathers/responsible parents to reduce childhood caries (2 and 3 years of age). Read more about this study
- Who is it for?
- Ages 12 to 14 months
- Conditions the study is for
- Dental Caries, Early Childhood Caries
- What is being tested?
- Motivational Interview and Traditional health education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2025
- Phase
- Interventional
- 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 12 to 14 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children born in 2014 in the attended territory of 12 Basic Health Units of the Community Health Service of Grupo Hospitalar Conceição, located in the city of Porto Alegre, Rio Grande do Sul, Brazil and who are correctly registered and under follow-up medical attention in the Children Program;
- Mothers/fathers/responsible adults: the person responsible for the child's oral health care and who follows all dental appointments in the health unit will be considered.
Who cannot join
- Children with special needs or syndromes;
- Children who left the attended territory of Community Health Service of Grupo Hospitalar Conceição health units for more than 6 consecutive months;
- Mothers/fathers/responsible adults without cognitive conditions to answer the study's surveys.
About this study
Official title: Impact of Preventive Child Oral Health Programs in Primary Health Care.
The purpose of this study is to compare the effectiveness of a traditional oral health educational program and a program based on the theories of the Motivational Interview directed to the child's mothers/fathers/responsible parents to reduce childhood caries (2 and 3 years of age).
Read the detailed description
Early Childhood Caries - ECC - is a highly prevalent and severe disease that affects children during their first years of life and, hence, requires early interventions and approaches, on an individual and collective basis. Early childhood is the ideal period to introduce good habits and begin an educational/preventive oral health program; however, family participation is utmost important, especially because the child's parents or responsible adults tend to pass improper knowledge on oral health care in this stage of life. Once prioritizing educational actions directed to this audience in primary health care is essential, Grupo Hospitalar Conceição's (Conceição Hospital Group - GHC) Community Health Service implemented, in its 12 Basic Health Units (UBS), an oral health action program with the goal that all children born after 2010 have at least one dental appointment in their first, second and third year of life. In these appointments, the child's oral health conditions are evaluated and their mother/father or responsible adult receive guidance on proper oral health care; however, little is known on the effectiveness of these preventive programs and what is their impact on ECC reduction in the population. With the purpose of qualifying oral health care strategies at the Brazilian Unified Health System's Primary Health Care (APS-SUS), with a scientific background, it is necessary to assess the effectiveness of these programmatic actions in comparison with conventional dental care by free demand. In light of this, this study has a technological innovation character, with a potential to be directly applicable in the oral health care staff of the Family Health Strategy program throughout Brazil.
The purpose of this study is to compare the effectiveness of a traditional oral health educational program and a program based on the theories of the Motivational Interview directed to the child's mothers/fathers/responsible parents to reduce childhood caries (2 and 3 years of age).
Randomized clinical trial nested in a cohort. The study will be conducted at SSC-GHC, which is composed of 12 Basic Health Units (UBS) located in the Northern region of the city of Porto Alegre, RS-Brazil.
- Conditions
- Dental Caries, Early Childhood Caries
- Being tested
- Motivational Interview, Traditional health education
- Keywords
- Early Childhood Caries, Randomized clinical trial, Motivational Interviewing
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewBehavioural
Traditional health educationOther
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview | Experimental | INTERVENTION GROUP: in this group, composed of 6 UBS, the children and their respective mothers/fathers/responsible adults will be attended by the dentists at least once a year with an approach based on the Motivational Interview. Receives: Behavioral: Motivational Interview |
| Traditional health education | Active comparator | CONTROL GROUP: in this group, composed of 6 UBS, the children and their respective mother/fathers/responsible adults will be attended by the dentists at least once a year based on the recommendations by the Brazilian Ministry of Health (BRASIL,2008-a) and on SSC-GHC's protocol (BRASIL, 2008-b). Additionally, the professional guidance script and the parents' booklet of SSC-GHC's oral health Program may be used. Receives: Other: Traditional health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing the prevalence of Early Childhood Caries after 3 years of follow verified by the ICDAS index (International Caries Detection & Assessment System) from the realization of reduction of at least 30% of the index pre and post intervention.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578966
- Sponsor's protocol ID
- HNSC-CZC
- Acronym
- CZC
- Status last verified
- Sep 2024
- First submitted
- 14 Oct 2015
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Colvara BC, Faustino-Silva DD, Meyer E, Hugo FN, Hilgert JB, Celeste RK. Motivational Interviewing in Preventing Early Childhood Caries in Primary Healthcare: A Community-based Randomized Cluster Trial. J Pediatr. 2018 Oct;201:190-195. doi: 10.1016/j.jpeds.2018.05.016. Epub 2018 Jun 6.
PubMed 29885752
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preventive Child Oral Health Programs in Primary Health Care.
- ClinicalTrials.gov ID
- NCT02578966
- Acronym / sponsor ID
- CZC / HNSC-CZC
- Conditions
- Dental Caries, Early Childhood Caries
- Keywords
- Early Childhood Caries, Randomized clinical trial, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Oct 2015 (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 purpose of this study is to compare the effectiveness of a traditional oral health educational program and a program based on the theories of the Motivational Interview directed to the child's mothers/fathers/responsible parents to reduce childhood caries (2 and 3 years of age).
Detailed description
Early Childhood Caries - ECC - is a highly prevalent and severe disease that affects children during their first years of life and, hence, requires early interventions and approaches, on an individual and collective basis. Early childhood is the ideal period to introduce good habits and begin an educational/preventive oral health program; however, family participation is utmost important, especially because the child's parents or responsible adults tend to pass improper knowledge on oral health care in this stage of life. Once prioritizing educational actions directed to this audience in primary health care is essential, Grupo Hospitalar Conceição's (Conceição Hospital Group - GHC) Community Health Service implemented, in its 12 Basic Health Units (UBS), an oral health action program with the goal that all children born after 2010 have at least one dental appointment in their first, second and third year of life. In these appointments, the child's oral health conditions are evaluated and their mother/father or responsible adult receive guidance on proper oral health care; however, little is known on the effectiveness of these preventive programs and what is their impact on ECC reduction in the population. With the purpose of qualifying oral health care strategies at the Brazilian Unified Health System's Primary Health Care (APS-SUS), with a scientific background, it is necessary to assess the effectiveness of these programmatic actions in comparison with conventional dental care by free demand. In light of this, this study has a technological innovation character, with a potential to be directly applicable in the oral health care staff of the Family Health Strategy program throughout Brazil.
The purpose of this study is to compare the effectiveness of a traditional oral health educational program and a program based on the theories of the Motivational Interview directed to the child's mothers/fathers/responsible parents to reduce childhood caries (2 and 3 years of age).
Randomized clinical trial nested in a cohort. The study will be conducted at SSC-GHC, which is composed of 12 Basic Health Units (UBS) located in the Northern region of the city of Porto Alegre, RS-Brazil.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview | Experimental | Behavioral: Motivational InterviewINTERVENTION GROUP: in this group, composed of 6 UBS, the children and their respective mothers/fathers/responsible adults will be attended by the dentists at least once a year with an approach based on the Motivational Interview. |
| Traditional health education | Active comparator | Other: Traditional health educationCONTROL GROUP: in this group, composed of 6 UBS, the children and their respective mother/fathers/responsible adults will be attended by the dentists at least once a year based on the recommendations by the Brazilian Ministry of Health (BRASIL,2008-a) and on SSC-GHC's protocol (BRASIL, 2008-b). Additionally, the professional guidance script and the parents' booklet of SSC-GHC's oral health Program may be used. |
Who may qualify
- Ages
- 12 to 14 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children born in 2014 in the attended territory of 12 Basic Health Units of the Community Health Service of Grupo Hospitalar Conceição, located in the city of Porto Alegre, Rio Grande do Sul, Brazil and who are correctly registered and under follow-up medical attention in the Children Program;
- Mothers/fathers/responsible adults: the person responsible for the child's oral health care and who follows all dental appointments in the health unit will be considered.
Key exclusion criteria (3 listed)
- Children with special needs or syndromes;
- Children who left the attended territory of Community Health Service of Grupo Hospitalar Conceição health units for more than 6 consecutive months;
- Mothers/fathers/responsible adults without cognitive conditions to answer the study's surveys.
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 |
|---|---|---|
| Motivational Interview | Behavioural | Motivational Interview |
| Traditional health education | Other | Traditional health education |
Primary outcome
Reducing the prevalence of Early Childhood Caries after 3 years of follow verified by the ICDAS index (International Caries Detection & Assessment System) from the realization of reduction of at least 30% of the index pre and post intervention.
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 29885752Colvara BC, Faustino-Silva DD, Meyer E, Hugo FN, Hilgert JB, Celeste RK. Motivational Interviewing in Preventing Early Childhood Caries in Primary Healthcare: A Community-based Randomized Cluster Trial. J Pediatr. 2018 Oct;201:190-195. doi: 10.1016/j.jpeds.2018.05.016. Epub 2018 Jun 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview and Traditional health education in people with Dental Caries and Early Childhood Caries, run by Hospital Nossa Senhora da Conceicao.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
Reducing the prevalence of Early Childhood Caries after 3 years of follow verified by the ICDAS index (International Caries Detection & Assessment System) from the realization of reduction of at least 30% of the index pre and post intervention. (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02578966, which also lists 1 linked publication.
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 19 Sep 2024; AzTrials last refreshed its copy on 27 Oct 2026.