Dental CariesPhase 4NCT03455621
Effect of the Amount of Fluoride Toothpaste on Fluoride Availability in the Oral Fluids in Children
A Phase 4 study testing Toothbrushing in people with Dental Caries, run by University of Campinas, Brazil.
Trial summary
The aim of the study is to determine the fluoride availability in saliva and dental biofilm after the use of increasing amounts of fluoride toothpaste. Using a crossover and blind design, 15 children (18-42 months old) had their teeth brushed with increasing amounts of fluoride toothpaste. Read more about this study
- Who is it for?
- Ages 18 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Toothbrushing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2010to 30 Jun 2011
- 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 18 to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children with an informed consent signed by the parents/guardians
Who cannot join
- Children with at least on active caries lesion
About this study
The aim of the study is to determine the fluoride availability in saliva and dental biofilm after the use of increasing amounts of fluoride toothpaste. Using a crossover and blind design, 15 children (18-42 months old) had their teeth brushed with increasing amounts of fluoride toothpaste. Fluoride concentration in saliva and dental biofilm was determined up to 30 min after brushing.
Read the detailed description
The aim of the study is to determine the fluoride availability in saliva and dental biofilm after the use of increasing amounts of fluoride toothpaste. Children from 18 to 42 months from a community daycare participated. The study had a crossover and blind design. The amounts of toothpastes tested were: 1. A pea-size amount (0.3 g) of a non-F toothpaste; 2. 0.025 g of a F toothpaste (1,100 ppm F, as NaF); 3. 0.05 g of the same F toothpaste; 4. 0.1 g of the same F toothpaste; or 5. 0.3 g (pea-size) of the same F toothpaste. Children were to brush their teeth with the designated amount of toothpaste twice/day from Monday to Friday. In order to allow biofilm accumulation, caregivers were instructed to brush only the occlusal surfaces of primary molars. On Friday morning, at least one hour after breakfast, saliva and one biofilm sample from the right or left hemiarch were collected and analyzed for fluoride concentration. Then, brushing with the respective amount of toothpaste was performed, and saliva was collected 5, 15 and 30 min later. The biofilm from the other side of the mouth was collected after 30 min. Fluoride concentration in saliva and biofilm samples was determined with an ion-specific electrode.
- Conditions
- Dental Caries
- Being tested
- Toothbrushing
- Keywords
- dental caries, fluoride, toothpaste, dentifrice
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothbrushingProcedure or surgery
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
| Study group | Role | What they receive |
|---|---|---|
| Pea-size amount of non-F dentifrice | Placebo comparator | Non-fluoride dentifrice (0 ppm F); to be used twice/day. Amount to be used: 0.3 g (pea-size amount) Receives: Procedure: Toothbrushing |
| 0.025 g of 1,100 ppm F dentifrice | Experimental | Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.025 g Receives: Procedure: Toothbrushing |
| 0.05 g of 1,100 ppm F dentifrice | Experimental | Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.05 g Receives: Procedure: Toothbrushing |
| 0.1 g of 1,100 ppm F dentifrice | Experimental | Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.1 g Receives: Procedure: Toothbrushing |
| Pea-size amount of 1,100 ppm F dentifrice | Active comparator | Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.3 g (pea-size amount) Receives: Procedure: Toothbrushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoride concentration in saliva before brushing
Measured: Before brushing (baseline)
Fluoride concentration in saliva 5 min after brushing
Measured: 5 minutes after brushing
Fluoride concentration in saliva 15 min after brushing
Measured: 15 min after brushing
Fluoride concentration in saliva 30 min after brushing
Measured: 30 min after brushing
Fluoride concentration in dental biofilm (fluid fraction) before brushing
Measured: Before brushing (baseline)
Fluoride concentration in dental biofilm (fluid fraction) 30 min after brushing
Measured: 30 min after brushing
Fluoride concentration in dental biofilm (solid fraction) before brushing
Measured: Before brushing (baseline)
Fluoride concentration in dental biofilm (solid fraction) 30 min after brushing
Measured: 30 min after brushing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Mar 2010
- Primary completion31 Dec 2010
- Study completion30 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Maria Andaló Tenuta, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455621
- Sponsor's protocol ID
- FOPBioq007
- Status last verified
- Feb 2018
- First submitted
- 21 Feb 2018
- Last updated
- 6 Mar 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 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Amount of Fluoride Toothpaste on Fluoride Availability in the Oral Fluids in Children
- ClinicalTrials.gov ID
- NCT03455621
- Acronym / sponsor ID
- FOPBioq007
- Conditions
- Dental Caries
- Keywords
- dental caries, fluoride, toothpaste, dentifrice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 30 Jun 2011 (actual)
- First posted
- 6 Mar 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.
The aim of the study is to determine the fluoride availability in saliva and dental biofilm after the use of increasing amounts of fluoride toothpaste. Using a crossover and blind design, 15 children (18-42 months old) had their teeth brushed with increasing amounts of fluoride toothpaste. Fluoride concentration in saliva and dental biofilm was determined up to 30 min after brushing.
Detailed description
The aim of the study is to determine the fluoride availability in saliva and dental biofilm after the use of increasing amounts of fluoride toothpaste. Children from 18 to 42 months from a community daycare participated. The study had a crossover and blind design. The amounts of toothpastes tested were: 1. A pea-size amount (0.3 g) of a non-F toothpaste; 2. 0.025 g of a F toothpaste (1,100 ppm F, as NaF); 3. 0.05 g of the same F toothpaste; 4. 0.1 g of the same F toothpaste; or 5. 0.3 g (pea-size) of the same F toothpaste. Children were to brush their teeth with the designated amount of toothpaste twice/day from Monday to Friday. In order to allow biofilm accumulation, caregivers were instructed to brush only the occlusal surfaces of primary molars. On Friday morning, at least one hour after breakfast, saliva and one biofilm sample from the right or left hemiarch were collected and analyzed for fluoride concentration. Then, brushing with the respective amount of toothpaste was performed, and saliva was collected 5, 15 and 30 min later. The biofilm from the other side of the mouth was collected after 30 min. Fluoride concentration in saliva and biofilm samples was determined with an ion-specific electrode.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pea-size amount of non-F dentifrice | Placebo comparator | Procedure: ToothbrushingNon-fluoride dentifrice (0 ppm F); to be used twice/day. Amount to be used: 0.3 g (pea-size amount) |
| 0.025 g of 1,100 ppm F dentifrice | Experimental | Procedure: ToothbrushingFluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.025 g |
| 0.05 g of 1,100 ppm F dentifrice | Experimental | Procedure: ToothbrushingFluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.05 g |
| 0.1 g of 1,100 ppm F dentifrice | Experimental | Procedure: ToothbrushingFluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.1 g |
| Pea-size amount of 1,100 ppm F dentifrice | Active comparator | Procedure: ToothbrushingFluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.3 g (pea-size amount) |
Who may qualify
- Ages
- 18 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children with an informed consent signed by the parents/guardians
Key exclusion criteria (1 listed)
- Children with at least on active caries lesion
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 |
|---|---|---|
| ToothbrushingToothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control) | Procedure or surgery | 0.025 g of 1,100 ppm F dentifrice, 0.05 g of 1,100 ppm F dentifrice, 0.1 g of 1,100 ppm F dentifrice, Pea-size amount of 1,100 ppm F dentifrice, Pea-size amount of non-F dentifrice |
Primary outcome
Fluoride concentration in saliva before brushing
Time frame: Before brushing (baseline)
Fluoride concentration in saliva 5 min after brushing
Time frame: 5 minutes after brushing
Fluoride concentration in saliva 15 min after brushing
Time frame: 15 min after brushing
Fluoride concentration in saliva 30 min after brushing
Time frame: 30 min after brushing
Fluoride concentration in dental biofilm (fluid fraction) before brushing
Time frame: Before brushing (baseline)
Fluoride concentration in dental biofilm (fluid fraction) 30 min after brushing
Time frame: 30 min after brushing
Fluoride concentration in dental biofilm (solid fraction) before brushing
Time frame: Before brushing (baseline)
Fluoride concentration in dental biofilm (solid fraction) 30 min after brushing
Time frame: 30 min after brushing
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 6 Mar 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 Toothbrushing in people with Dental Caries, run by University of Campinas, 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 1 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 6 Mar 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. Some participants in this study may receive a placebo. 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?
Fluoride concentration in saliva before brushing (time frame: Before brushing (baseline)). The study lists 8 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 6 Mar 2018.