Caries, DentalPhase 4NCT03761485
Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice
A Phase 4 study testing Use of Dentifrice Fluoride in people with Caries, Dental and Fluorosis, Dental, run by Federal University of Paraíba.
Trial summary
This research aimed to evaluate the risk of dental fluorosis by using an experimental fluoridated acidulated dentifrice compared to conventional dentifrices in two-to-four-year-old children residing in a non fluoridated area by the concentration of fluoride incorporated in childrens' nails, as well as the… Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental, Fluorosis, Dental
- What is being tested?
- Use of Dentifrice Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2015to 15 Jan 2018
- Phase
- Phase 4
- 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 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age group of 2 to 4 years of age of both sexes
- Who were enrolled in one of the 3 CREIs that participated in the research
- Presence of deciduos teeth
Who cannot join
- Presented high mobility of the children (incompatible with the planning of a longitudinal study)
- Children who did not allow the clinical examination in the school
- Children using orthodontic appliances or children with extensive caries lesions with dentin sensitivity
- Children not residing in the city of João Pessoa-PB from birth to 4 years due to the fluoridation of water from public supply.
About this study
Official title: Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice: Clinical Trial - Epidemiological Study With Children Residing in an área Without Public Water Fluoridation
This research aimed to evaluate the risk of dental fluorosis by using an experimental fluoridated acidulated dentifrice compared to conventional dentifrices in two-to-four-year-old children residing in a non fluoridated area by the concentration of fluoride incorporated in childrens' nails, as well as the incorporation of F into the biofilm. Two hundred and ten children participated on this study. They were randomly allocated into three groups differing according to the type of dentifrice used over 12 months: G1:1100 ppm F, pH 4.5; G2:750 ppm F, pH 4.5; G3:1100 ppm F, pH 7.0. The dentifrice was placed on the toothbrush using the "drop" technique. The toenails of the biggest toe were collected in three moments, corresponding to the experimental period of use of the dentifrices (T1, T2 and T3), as well as the biofilm which was collected twice, 5 and 60 minutes after brushing. The nails and biofilm fluoride concentration were analyzed on a specific electrode using the HMDS diffusion facilitated technique.
Read the detailed description
This is a randomized, double-blind, interventional trial, adopting a strategy for collecting data, collecting data from the children's biofilm. This study was carried out in three Child Education Reference Centers (CREIs) located in different points of the city of João Pessoa PB.
The city is located in the Northeast region of Brazil, on the coast of the state of Paraíba and has about 600 thousand inhabitants (IBGE, 2013). João Pessoa has already had fluoridated water for a period of two years until the mid-1980s, but so far the project has been deactivated.
The 452 children participating in the study were divided into three groups according to the dentifrice used in a 12 - month period: G1: 1,100 ppm F - pH 4.5; G2: 750 ppm F-pH 4.5; and G3: 1100 ppm F-pH 7.0. The toothpaste was supplied by Oralls (São Jose dos Campos-SP, Brazil) and dental brushes by Bitufo (Hypermarcas, São Paulo, SP-, Brazil) and there was no conflict of interest. For the random distribution of the groups, the CREIs were considered as units, so that only one type of toothpaste was distributed in each CREI, thus facilitating the control of the dentifrices delivery by the teachers, as well as the supervised brushing in CREI itself.
The toenails of the biggest toe were collected in three moments, corresponding to the experimental period of use of the dentifrices (T1, T2 and T3), as well as the biofilm which was collected twice, 5 and 60 minutes after brushing. The nails and biofilm fluoride concentration were analyzed on a specific electrode using the HMDS diffusion facilitated technique.
Nails of the large toes were collected because they provide a sufficient nail mass for analysis and because there has been a reported possibility of contamination of the toenails (Buzalaf, Pessan et al., 2006). The nail samples of each child were cleaned with deionized water using a dental brush, taken to the ultrasound apparatus with deionized water for 10 min, dried at 60 ± 5 ° C and weighed on the analytical balance The presence of F was analyzed as described in the previous item, according to the method of Taves (1968), as modified by Whitford (1996). F patterns (0.00475, 0.0095, 0.019, 0.095, 0.190 and 0.95 mg F) were prepared by serial dilution of a stock solution of 0.1 MF (Orion) in triplicate and diffused in the same manner as the samples. The average repeatability of the readings based on duplicate samples was 95%. Whenever the sample weight was> 20 mg, the analysis was performed in duplicate.
- Conditions
- Caries, Dental, Fluorosis, Dental
- Being tested
- Use of Dentifrice Fluoride
- Medical subject headings
- Dental Caries, Fluorosis, Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Dentifrice FluorideOther
Use of few of dentifrice on brushing during a year
| Study group | Role | What they receive |
|---|---|---|
| Dentifrice 750 ppm of NaF acidulated | Experimental | Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months Receives: Other: Use of Dentifrice Fluoride |
| Dentifrice 1.100 ppm of NaF neutral | Active comparator | Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months Receives: Other: Use of Dentifrice Fluoride |
| Dentifrice 1.100 ppm of NaF acidulated | Active comparator | Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months Receives: Other: Use of Dentifrice Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of intraoral fluoride
Effective of capacity to concentration of fluoride in biofilm (ppm)
Measured: 1 year
Effect of intraoral fluoride - software
Reduction of initial lesions carie give by mm² analysed by software
Measured: 1 year
Effect of intraoral fluoride
Reduction of initial lesions carie give by visual scale (Nyvad scale)
Measured: 1 year
Concentration of nail fluorid
Concentration of fluoride in nail (ppm)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start15 Jan 2015
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Correia Sampaio, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761485
- Sponsor's protocol ID
- Acidulated fluoride dentifrice
- Status last verified
- Nov 2018
- First submitted
- 25 Aug 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice: Clinical Trial - Epidemiological Study With Children Residing in an área Without Public Water Fluoridation
- ClinicalTrials.gov ID
- NCT03761485
- Acronym / sponsor ID
- Acidulated fluoride dentifrice
- Conditions
- Caries, Dental, Fluorosis, Dental
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 3 Dec 2018 (actual)
- 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.
This research aimed to evaluate the risk of dental fluorosis by using an experimental fluoridated acidulated dentifrice compared to conventional dentifrices in two-to-four-year-old children residing in a non fluoridated area by the concentration of fluoride incorporated in childrens' nails, as well as the incorporation of F into the biofilm. Two hundred and ten children participated on this study. They were randomly allocated into three groups differing according to the type of dentifrice used over 12 months: G1:1100 ppm F, pH 4.5; G2:750 ppm F, pH 4.5; G3:1100 ppm F, pH 7.0. The dentifrice was placed on the toothbrush using the "drop" technique. The toenails of the biggest toe were collected in three moments, corresponding to the experimental period of use of the dentifrices (T1, T2 and T3), as well as the biofilm which was collected twice, 5 and 60 minutes after brushing. The nails and biofilm fluoride concentration were analyzed on a specific electrode using the HMDS diffusion facilitated technique.
Detailed description
This is a randomized, double-blind, interventional trial, adopting a strategy for collecting data, collecting data from the children's biofilm. This study was carried out in three Child Education Reference Centers (CREIs) located in different points of the city of João Pessoa PB.
The city is located in the Northeast region of Brazil, on the coast of the state of Paraíba and has about 600 thousand inhabitants (IBGE, 2013). João Pessoa has already had fluoridated water for a period of two years until the mid-1980s, but so far the project has been deactivated.
The 452 children participating in the study were divided into three groups according to the dentifrice used in a 12 - month period: G1: 1,100 ppm F - pH 4.5; G2: 750 ppm F-pH 4.5; and G3: 1100 ppm F-pH 7.0. The toothpaste was supplied by Oralls (São Jose dos Campos-SP, Brazil) and dental brushes by Bitufo (Hypermarcas, São Paulo, SP-, Brazil) and there was no conflict of interest. For the random distribution of the groups, the CREIs were considered as units, so that only one type of toothpaste was distributed in each CREI, thus facilitating the control of the dentifrices delivery by the teachers, as well as the supervised brushing in CREI itself.
The toenails of the biggest toe were collected in three moments, corresponding to the experimental period of use of the dentifrices (T1, T2 and T3), as well as the biofilm which was collected twice, 5 and 60 minutes after brushing. The nails and biofilm fluoride concentration were analyzed on a specific electrode using the HMDS diffusion facilitated technique.
Nails of the large toes were collected because they provide a sufficient nail mass for analysis and because there has been a reported possibility of contamination of the toenails (Buzalaf, Pessan et al., 2006). The nail samples of each child were cleaned with deionized water using a dental brush, taken to the ultrasound apparatus with deionized water for 10 min, dried at 60 ± 5 ° C and weighed on the analytical balance The presence of F was analyzed as described in the previous item, according to the method of Taves (1968), as modified by Whitford (1996). F patterns (0.00475, 0.0095, 0.019, 0.095, 0.190 and 0.95 mg F) were prepared by serial dilution of a stock solution of 0.1 MF (Orion) in triplicate and diffused in the same manner as the samples. The average repeatability of the readings based on duplicate samples was 95%. Whenever the sample weight was> 20 mg, the analysis was performed in duplicate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized double blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Dentifrice 750 ppm of NaF acidulated | Experimental | Other: Use of Dentifrice FluorideUse of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months |
| Dentifrice 1.100 ppm of NaF neutral | Active comparator | Other: Use of Dentifrice FluorideUse of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months |
| Dentifrice 1.100 ppm of NaF acidulated | Active comparator | Other: Use of Dentifrice FluorideUse of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age group of 2 to 4 years of age of both sexes
- Who were enrolled in one of the 3 CREIs that participated in the research
- Presence of deciduos teeth
Key exclusion criteria (4 listed)
- Presented high mobility of the children (incompatible with the planning of a longitudinal study)
- Children who did not allow the clinical examination in the school
- Children using orthodontic appliances or children with extensive caries lesions with dentin sensitivity
- Children not residing in the city of João Pessoa-PB from birth to 4 years due to the fluoridation of water from public supply.
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 |
|---|---|---|
| Use of Dentifrice FluorideUse of few of dentifrice on brushing during a year | Other | Dentifrice 1.100 ppm of NaF acidulated, Dentifrice 1.100 ppm of NaF neutral, Dentifrice 750 ppm of NaF acidulated |
Primary outcome
Concentration of intraoral fluoride
Time frame: 1 year
Effective of capacity to concentration of fluoride in biofilm (ppm)
Effect of intraoral fluoride - software
Time frame: 1 year
Reduction of initial lesions carie give by mm² analysed by software
Effect of intraoral fluoride
Time frame: 1 year
Reduction of initial lesions carie give by visual scale (Nyvad scale)
Concentration of nail fluorid
Time frame: 1 year
Concentration of fluoride in nail (ppm)
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 3 Dec 2018.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Use of Dentifrice Fluoride in people with Caries, Dental and Fluorosis, Dental, run by Federal University of Paraíba.
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 3 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 3 Dec 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Concentration of intraoral fluoride (time frame: 1 year). The study lists 4 primary outcomes in all. 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 3 Dec 2018.