Healthy IndividualsFNCT01568541
Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes
A study testing Regular toothpastes and Children's toothpastes in people with Healthy Individuals, run by Federal University of Minas Gerais at 3 sites in Brazil.
Trial summary
There are controversial data about fluoride intake by children when tooth brushing with children's or regular toothpastes. However, a study have showed that children were exposed to a dose of 0.051 mg F/Kg/day and 0.046 mg F/kg/day by tooth brushing with children's and and regular toothpaste, respectively. Read more about this study
- Who is it for?
- Ages 6 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Regular toothpastes and Children's toothpastes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 3 sitesBrazil
- Study dates
- Oct 2007to Mar 2009
- 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 6 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Consent demonstrates understanding of the study and willingness to participate as evidenced by voluntary written of informed consent and has received a signed and dated copy of the informed consent form.
- Age up to 48 months.
- Compliance understands of the study and ability to comply with the study procedures.
- Good oral health as considered by the investigator.
- Good general health as considered by the investigator, with no clinically significant and/or relevant abnormalities of medical history.
Who cannot join
- Children aging older than 48 months or younger of 6 months.
- Parents who do not allow the child's participation.
- Children that refuse to follow the study procedure.
- Volunteers that do not complete the whole study protocol.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
State University of Montes Claros
Montes Claros, Minas Gerais, 39401-089
Piracicaba School of Dentistry of State University of Campinas
Piracicaba, São Paulo, 13414-903
About this study
Official title: Fluoride Intake From Tooth Brushing With Children's and Regular Toothpastes: a Study With Preschooler Children
There are controversial data about fluoride intake by children when tooth brushing with children's or regular toothpastes. However, a study have showed that children were exposed to a dose of 0.051 mg F/Kg/day and 0.046 mg F/kg/day by tooth brushing with children's and and regular toothpaste, respectively. Fluorides doses were too close and is questioned if there is a real clinical relevance in terms of risk of dental fluorosis. It is important to evaluate if children's toothpastes does really represent a risk of fluoride intake when compared to the regular toothpastes in terms of risk of dental fluorosis. The hypothesis is that both children's and regular toothpastes can represente risks of development of dental fluorosis and can represent similar fluoride exposure by children.
Read the detailed description
Subjects: Children at age of development of dental fluorosis (up to 4 years) enrolled at day care centres from the city of Montes Claros (0.7 ppm F), Brazil.
The study design has two phases:
- In the first phase, children are required to bring at the day care centres the tooth brush and the toothpaste used at home. There is no randomization, since the inclusion in either children's or regular toothpaste groups will be done based on each child's preference. The children are requested to tooth brush as the usual manner that the parent and the child do at home. Saliva expectorates are collected as the protocol described by Guha-Chowdhury et al. (1996). No instructions are provided in this phase or interventions by the researcher. Saliva expectorates are collected for further laboratory analysis. Toothpastes are collected for laboratory analysis.
- In the second phase, children are required to toothbrush with other type of toothbrush following the same tooth brushing protocol. For example, children that previously used children's toothpaste will be provided a regular toothpaste, and vice-versa.
Parents are requested to answer a questionnaire regarding their children's tooth brushing habits and socioeconomic factors.
Laboratory analysis provides estimation of fluoride intake from tooth brushing with both toothpastes.
Analysis will base on dose of fluoride intake (mg F/Kg body weight/day) considering children's and regular toothpastes.
- Conditions
- Healthy Individuals
- Being tested
- Regular toothpastes, Children's toothpastes
- Keywords
- children, dentifrice, fluoride, dental fluorosis
- Medical subject headings
- Fluorosis, Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular toothpastesDrug
One tooth brushing
Children's toothpastesDrug
One tooth brushing
| Study group | Role | What they receive |
|---|---|---|
| Children' toothpaste | Active comparator | Children's toothpastes Receives: Drug: Regular toothpastes |
| Regular toothpastes | Active comparator | Regular toothpastes Receives: Drug: Children's toothpastes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of mean dose of fluoride intake from tooth brushing with children's and regular toothpastes.
Measured: One week interval between two tooth brushings
Secondary outcomes (1)
Fluoride concentrations in toothpastes used by children.
Measured: From date of toothpastes collection until laboratorial analysis, assessed up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy IndividualsStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil, State University of Montes Claros, Coordination for the Improvement of Higher Education Personnel, Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Carolina Castro Martins, Federal University of Minas Gerais
- Investigators
- Carolina C Martins, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568541
- Sponsor's protocol ID
- NCT17591320
- Acronym
- F
- Status last verified
- Sep 2012
- First submitted
- 28 Mar 2012
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martins CC, Paiva SM, Lima-Arsati YB, Ramos-Jorge ML, Cury JA. Prospective study of the association between fluoride intake and dental fluorosis in permanent teeth. Caries Res. 2008;42(2):125-33. doi: 10.1159/000119520. Epub 2008 Mar 4.
PubMed 18319589Martins CC, Paiva SM, Cury JA. Effect of discontinuation of fluoride intake from water and toothpaste on urinary excretion in young children. Int J Environ Res Public Health. 2011 Jun;8(6):2132-41. doi: 10.3390/ijerph8062132. Epub 2011 Jun 10.
PubMed 21776221Oliveira MJ, Paiva SM, Martins LH, Ramos-Jorge ML, Lima YB, Cury JA. Fluoride intake by children at risk for the development of dental fluorosis: comparison of regular dentifrices and flavoured dentifrices for children. Caries Res. 2007;41(6):460-6. doi: 10.1159/000107933. Epub 2007 Sep 7.
PubMed 17823508Cury JA, Oliveira MJ, Martins CC, Tenuta LM, Paiva SM. Available fluoride in toothpastes used by Brazilian children. Braz Dent J. 2010;21(5):396-400. doi: 10.1590/s0103-64402010000500003.
PubMed 21180793Martins CC, Oliveira MJ, Pordeus IA, Cury JA, Paiva SM. Association between socioeconomic factors and the choice of dentifrice and fluoride intake by children. Int J Environ Res Public Health. 2011 Nov;8(11):4284-99. doi: 10.3390/ijerph8114284. Epub 2011 Nov 10.
PubMed 22163207
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoride Intake From Tooth Brushing With Children's and Regular Toothpastes: a Study With Preschooler Children
- ClinicalTrials.gov ID
- NCT01568541
- Acronym / sponsor ID
- F / NCT17591320
- Conditions
- Healthy Individuals
- Keywords
- children, dentifrice, fluoride, dental fluorosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil, State University of Montes Claros, Coordination for the Improvement of Higher Education Personnel, Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Apr 2012 (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.
There are controversial data about fluoride intake by children when tooth brushing with children's or regular toothpastes. However, a study have showed that children were exposed to a dose of 0.051 mg F/Kg/day and 0.046 mg F/kg/day by tooth brushing with children's and and regular toothpaste, respectively. Fluorides doses were too close and is questioned if there is a real clinical relevance in terms of risk of dental fluorosis. It is important to evaluate if children's toothpastes does really represent a risk of fluoride intake when compared to the regular toothpastes in terms of risk of dental fluorosis. The hypothesis is that both children's and regular toothpastes can represente risks of development of dental fluorosis and can represent similar fluoride exposure by children.
Detailed description
Subjects: Children at age of development of dental fluorosis (up to 4 years) enrolled at day care centres from the city of Montes Claros (0.7 ppm F), Brazil.
The study design has two phases:
- In the first phase, children are required to bring at the day care centres the tooth brush and the toothpaste used at home. There is no randomization, since the inclusion in either children's or regular toothpaste groups will be done based on each child's preference. The children are requested to tooth brush as the usual manner that the parent and the child do at home. Saliva expectorates are collected as the protocol described by Guha-Chowdhury et al. (1996). No instructions are provided in this phase or interventions by the researcher. Saliva expectorates are collected for further laboratory analysis. Toothpastes are collected for laboratory analysis.
- In the second phase, children are required to toothbrush with other type of toothbrush following the same tooth brushing protocol. For example, children that previously used children's toothpaste will be provided a regular toothpaste, and vice-versa.
Parents are requested to answer a questionnaire regarding their children's tooth brushing habits and socioeconomic factors.
Laboratory analysis provides estimation of fluoride intake from tooth brushing with both toothpastes.
Analysis will base on dose of fluoride intake (mg F/Kg body weight/day) considering children's and regular toothpastes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children' toothpaste | Active comparator | Drug: Regular toothpastesChildren's toothpastes |
| Regular toothpastes | Active comparator | Drug: Children's toothpastesRegular toothpastes |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Consent demonstrates understanding of the study and willingness to participate as evidenced by voluntary written of informed consent and has received a signed and dated copy of the informed consent form.
- Age up to 48 months.
- Compliance understands of the study and ability to comply with the study procedures.
- Good oral health as considered by the investigator.
- Good general health as considered by the investigator, with no clinically significant and/or relevant abnormalities of medical history.
Key exclusion criteria (4 listed)
- Children aging older than 48 months or younger of 6 months.
- Parents who do not allow the child's participation.
- Children that refuse to follow the study procedure.
- Volunteers that do not complete the whole study protocol.
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 |
|---|---|---|
| Regular toothpastesOne tooth brushing | Drug | Children' toothpaste |
| Children's toothpastesOne tooth brushing | Drug | Regular toothpastes |
Primary outcome
Evidence of mean dose of fluoride intake from tooth brushing with children's and regular toothpastes.
Time frame: One week interval between two tooth brushings
1 secondary outcome
Fluoride concentrations in toothpastes used by children.
Time frame: From date of toothpastes collection until laboratorial analysis, assessed up to 4 months
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 18 Sep 2012.
- Background: PubMed 18319589Martins CC, Paiva SM, Lima-Arsati YB, Ramos-Jorge ML, Cury JA. Prospective study of the association between fluoride intake and dental fluorosis in permanent teeth. Caries Res. 2008;42(2):125-33. doi: 10.1159/000119520. Epub 2008 Mar 4.
- Background: PubMed 21776221Martins CC, Paiva SM, Cury JA. Effect of discontinuation of fluoride intake from water and toothpaste on urinary excretion in young children. Int J Environ Res Public Health. 2011 Jun;8(6):2132-41. doi: 10.3390/ijerph8062132. Epub 2011 Jun 10.
- Background: PubMed 17823508Oliveira MJ, Paiva SM, Martins LH, Ramos-Jorge ML, Lima YB, Cury JA. Fluoride intake by children at risk for the development of dental fluorosis: comparison of regular dentifrices and flavoured dentifrices for children. Caries Res. 2007;41(6):460-6. doi: 10.1159/000107933. Epub 2007 Sep 7.
- Results publication: PubMed 21180793Cury JA, Oliveira MJ, Martins CC, Tenuta LM, Paiva SM. Available fluoride in toothpastes used by Brazilian children. Braz Dent J. 2010;21(5):396-400. doi: 10.1590/s0103-64402010000500003.
- Results publication: PubMed 22163207Martins CC, Oliveira MJ, Pordeus IA, Cury JA, Paiva SM. Association between socioeconomic factors and the choice of dentifrice and fluoride intake by children. Int J Environ Res Public Health. 2011 Nov;8(11):4284-99. doi: 10.3390/ijerph8114284. Epub 2011 Nov 10.
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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.
Carolina C Martins, PhD principal investigator
Federal University of Minas Gerais
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular toothpastes and Children's toothpastes in people with Healthy Individuals, run by Federal University of Minas Gerais at 3 sites in Brazil.
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 5 inclusion and 4 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 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Evidence of mean dose of fluoride intake from tooth brushing with children's and regular toothpastes. (time frame: One week interval between two tooth brushings). 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 NCT01568541, which also lists 5 linked publications.
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 18 Sep 2012.