Dental FluorosisPhase 3EPHFCDCCNCT01049503

Effect of pH and Fluoride Concentration of Dentifrices on Caries Control

A Phase 3 study testing Low fluoride and conventional dentifrices with different pH in people with Dental Fluorosis and Dental Caries, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 4 yearsHealthy volunteers can take part
Conditions the study is for: Dental Fluorosis, Dental Caries
What is being tested?: Low fluoride and conventional dentifrices with different pH
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 315 participants
Where: 1 siteBrazil
Study dates: Nov 2009to Feb 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

>= 2 years and <= 4 years
Not having participated in any other clinical study within 3 months prior to selection;
Not having very large carious lesions or dentin sensitivity during the study (if this occurs, the child will be referred for treatment);
Signature of informed consent by the parents

Who cannot join

Using orthodontic appliances

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Public primary schools in Bauru
Bauru, São Paulo

Other trials in Brazil

About this study

Official title: Effect of pH and Fluoride Concentration of Liquid Dentifrices on Caries Control in a Fluoridated Area: a Randomized Clinical Trial

This study aims to assess the overall effect of pH and fluoride concentration of liquid dentifrices in the control of children dental caries of a fluoridated area, through visual inspection and the quantitative light-induced fluorescence (QLF) method. Toenail F concentration of a subsample of the children enrolled will be evaluated, in order to assess F bioavailability from these formulations and the evaluation of the concentration of fluoride incorporated into the biofilm will be done 6 months after initiation of the dentifrices use.

Read the detailed description

Dentifrices have been recognized as one of the contributors in the increased prevalence of dental fluorosis, due to the fact that children in early childhood usually eat lots of them during brushing. As an alternative to the reduction of fluorosis have been suggested to reduce the concentration of fluoride toothpaste, however, its efficacy is not well established, increasing when the pH of the toothpaste is acidic, with a greater diffusion of F in the enamel. Therefore, this study aims to assess the overall effect of pH and fluoride concentration of liquid dentifrices in the control of children dental caries of a fluoridated area. A randomized double-blind study will be conducted with approximately 360 children aged 2 to 4 years old at public daycare centers located in a fluoridated area. Children will be examined by two examiners and classified according to caries activity. For 12 months, children will use 3 times a day, one of the toothpaste to be tested, with different concentrations of fluoride and pH. At the end of this period, children will be examined by the same examiners to check the progression of lesions. Clinical examinations should be performed by 2 calibrated examiners (kappa 0.8) at baseline and after 12 months. The diagnostic criteria of caries activity (active, inactive) and integrity of the surface of the lesion will be used. There will be a quantitative assessment of carious lesions fluorescence with a portable QLF equipment. In half of the sample, nails and plaque will be collected 6 months after initiation of the dentifrices use. Samples of plaque will be analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). The presence of nails F will be analyzed as described above. For statistical analysis will be used ANOVA and test for individual comparisons.

Conditions: Dental Fluorosis, Dental Caries
Being tested: Low fluoride and conventional dentifrices with different pH
Keywords: Dentifrices, Fluoride, Nails, Plaque
Medical subject headings: Fluorosis, Dental, Dental Caries, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low fluoride and conventional dentifrices with different pHOther
Also called Dentifrice with 550 ppm F (NaF) and neutral pH (7.0), Dentifrice with 550 ppm F (NaF) and acidic pH (4.5), Dentifrice with 1100 ppm F (NaF) and neutral pH (7.0)
Comparison of different dentifrice fluoride concentrations and pH on caries control

Study groups in NCT01049503
Study group	Role	What they receive
Caries-active 550 ppm F, pH 7.0	Active comparator	This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months. Receives: Other: Low fluoride and conventional dentifrices with different pH
Caries-active 550 ppm F, pH 4.5	Active comparator	This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months. Receives: Other: Low fluoride and conventional dentifrices with different pH
Caries-active 1100 ppm F, pH 7.0	Active comparator	This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months. Receives: Other: Low fluoride and conventional dentifrices with different pH
Caries-inactive 550 ppm F, pH 7.0	Active comparator	This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months. Receives: Other: Low fluoride and conventional dentifrices with different pH
Caries-inactive 550 ppm F, pH 4.5	Active comparator	This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months. Receives: Other: Low fluoride and conventional dentifrices with different pH
Caries-inactive 1100 ppm F, pH 7.0	Active comparator	This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months. Receives: Other: Low fluoride and conventional dentifrices with different pH

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.
Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).
Measured: 6 months
Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.
Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).
Measured: 6 months

Secondary outcomes (5)

Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used
The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.
Measured: baseline and 12 months
Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used
The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.
Measured: baseline and 12 months
Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the Quantitative Light Induced Method (QLF)(Fluorescence Change (∆F in %))
The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline - 12 months)were calculated by the software at the QLF threshold of 5%. A negative ∆F value indicates caries regression.
Measured: baseline and 12 months
Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the the Quantitative Light Induced Method (QLF) (Lesion Area (mm^2))
The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline - 12 months)were calculated by the software at the QLF threshold of 5%.
Measured: baseline and 12 months
Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used
The lesions' progression was evaluated by the data from the examinations at baseline and after 12 months. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an ANC lesion or cavity (untreated cavity or filled tooth).
Measured: baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Feb 2012

First posted14 Jan 2010 (estimated)
Study startNov 2009
Primary completionDec 2010
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dental FluorosisStudies of the same condition, open and under way.
More trials run by University of Sao PauloThe sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 315 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01049503
Sponsor's protocol ID: USP0162009
Acronym: EPHFCDCC
Status last verified: Aug 2012
First submitted: 12 Jan 2010
Last updated: 30 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

de Almeida Baldini Cardoso C, Mangueira DF, Olympio KP, Magalhaes AC, Rios D, Honorio HM, Vilhena FV, Sampaio FC, Buzalaf MA. The effect of pH and fluoride concentration of liquid dentifrices on caries progression. Clin Oral Investig. 2014 Apr;18(3):761-7. doi: 10.1007/s00784-013-1031-2. Epub 2013 Jul 20.
PubMed 23873319

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingObservational study
Clinical Severity of Dental Fluorosis and Associated Risk Factors Among a Group of Children in Rural Region, Dendera Center in Egypt
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RecruitingObservational study
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Not yet recruitingPhase 4
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All Dental Fluorosis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of pH and Fluoride Concentration of Liquid Dentifrices on Caries Control in a Fluoridated Area: a Randomized Clinical Trial
ClinicalTrials.gov ID: NCT01049503
Acronym / sponsor ID: EPHFCDCC / USP0162009
Conditions: Dental Fluorosis, Dental Caries
Keywords: Dentifrices, Fluoride, Nails, Plaque
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 315 participants (actual)
Lead sponsor: University of Sao PauloUniversity, hospital or other
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Study start: Nov 2009
Primary completion: Dec 2010 (actual)
Study completion: Feb 2012 (actual)
First posted: 14 Jan 2010 (estimated)
Results: Posted 21 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Caries-active 550 ppm F, pH 7.0	Active comparator	Other: Low fluoride and conventional dentifrices with different pHThis arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
Caries-active 550 ppm F, pH 4.5	Active comparator	Other: Low fluoride and conventional dentifrices with different pHThis arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
Caries-active 1100 ppm F, pH 7.0	Active comparator	Other: Low fluoride and conventional dentifrices with different pHThis arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
Caries-inactive 550 ppm F, pH 7.0	Active comparator	Other: Low fluoride and conventional dentifrices with different pHThis arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
Caries-inactive 550 ppm F, pH 4.5	Active comparator	Other: Low fluoride and conventional dentifrices with different pHThis arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
Caries-inactive 1100 ppm F, pH 7.0	Active comparator	Other: Low fluoride and conventional dentifrices with different pHThis arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.

Who may qualify

Ages: 2 to 4 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

>= 2 years and <= 4 years
Not having participated in any other clinical study within 3 months prior to selection;
Not having very large carious lesions or dentin sensitivity during the study (if this occurs, the child will be referred for treatment);
Signature of informed consent by the parents

Key exclusion criteria (1 listed)

Using orthodontic appliances

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
Low fluoride and conventional dentifrices with different pHAlso: Dentifrice with 550 ppm F (NaF) and neutral pH (7.0), Dentifrice with 550 ppm F (NaF) and acidic pH (4.5), Dentifrice with 1100 ppm F (NaF) and neutral pH (7.0)Comparison of different dentifrice fluoride concentrations and pH on caries control	Other	Caries-active 1100 ppm F, pH 7.0, Caries-active 550 ppm F, pH 4.5, Caries-active 550 ppm F, pH 7.0, Caries-inactive 1100 ppm F, pH 7.0, Caries-inactive 550 ppm F, pH 4.5, Caries-inactive 550 ppm F, pH 7.0

Primary outcome

Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.
Time frame: 6 months
Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).
Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.
Time frame: 6 months
Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).

5 secondary outcomes

Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used
Time frame: baseline and 12 months
Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used
Time frame: baseline and 12 months
Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the Quantitative Light Induced Method (QLF)(Fluorescence Change (∆F in %))
Time frame: baseline and 12 months
Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the the Quantitative Light Induced Method (QLF) (Lesion Area (mm^2))
Time frame: baseline and 12 months
Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used
Time frame: baseline and 12 months

Results and safety

Results posted to the registry on 21 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Caries-active 550 Ppm F, pH 7.0	52	41
Caries-active 550 Ppm F, pH 4.5	48	36
Caries-active 1100 Ppm F, pH 7.0	56	32
Caries-inactive 550ppm F, pH 7.0	55	29
Caries-inactive 550 Ppm F, pH 4.5	56	29
Caries-inactive 1100 Ppm F, pH 7.0	48	40

Primary outcome: Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.

Time frame: 6 months. Mean (Standard Deviation). Unit: mmol/kg

Measure	550 Ppm F, pH 7.0 n = 16	550 Ppm F, pH 4.5 n = 15	1100 ppmF , pH 7.0 n = 16
Value	0.80 (0.08)	1.32 (0.23)	1.74 (0.24)

550 Ppm F, pH 7.0 vs 550 Ppm F, pH 4.5 vs 1100 ppmF , pH 7.0: p <0.05, ANOVA

Population analysed: The sample size was calculated according to Pessan et al. (2008). From the trial participants in the fluoridated area, a convenience sample of 47 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.

Primary outcome: Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.

Time frame: 6 months. Mean (Standard Deviation). Unit: µgF/g

Measure	550 Ppm F, pH 7.0 n = 58	550 Ppm F, pH 4.5 n = 53	1100 Ppm F, pH 7.0 n = 50
Value	1.73 (0.68)	1.80 (0.92)	2.56 (1.31)

550 Ppm F, pH 7.0 vs 550 Ppm F, pH 4.5 vs 1100 Ppm F, pH 7.0: p <0.05, ANOVA

Population analysed: The sample size was calculated according to Buzalaf et al. (2009). From the trial participants in the fluoridated area, a convenience sample of 161 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Caries-active 550 Ppm F, pH 7.0	0 of 52 (0%)	0 of 52 (0%)	Not reported
Caries-active 550 Ppm F, pH 4.5	0 of 48 (0%)	0 of 48 (0%)	Not reported
Caries-active 1100 Ppm F, pH 7.0	0 of 56 (0%)	0 of 56 (0%)	Not reported
Caries-inactive 550ppm F, pH 7.0	0 of 55 (0%)	0 of 55 (0%)	Not reported
Caries-inactive 550 Ppm F, pH 4.5	0 of 56 (0%)	0 of 56 (0%)	Not reported
Caries-inactive 1100 Ppm F, pH 7.0	0 of 48 (0%)	0 of 48 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23873319de Almeida Baldini Cardoso C, Mangueira DF, Olympio KP, Magalhaes AC, Rios D, Honorio HM, Vilhena FV, Sampaio FC, Buzalaf MA. The effect of pH and fluoride concentration of liquid dentifrices on caries progression. Clin Oral Investig. 2014 Apr;18(3):761-7. doi: 10.1007/s00784-013-1031-2. Epub 2013 Jul 20.

Related trials for Dental Fluorosis

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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.

Marília AR Buzalaf, PhD principal investigator

Bauru Dental School, University of São Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Low fluoride and conventional dentifrices with different pH in people with Dental Fluorosis and Dental Caries, run by University of Sao Paulo at 1 site 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 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 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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?

Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01049503, 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 30 Aug 2012.