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Effect of pH and Fluoride Concentration of Dentifrices on Caries Control

NCT ID: NCT01049503

Last Updated: 2012-08-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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

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Dental Fluorosis Dental Caries

Keywords

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Dentifrices Fluoride Nails Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Caries-inactive 1100 ppm F, pH 7.0

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.

Group Type ACTIVE_COMPARATOR

Low fluoride and conventional dentifrices with different pH

Intervention Type OTHER

Comparison of different dentifrice fluoride concentrations and pH on caries control

Caries-active 550 ppm F, pH 7.0

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.

Group Type ACTIVE_COMPARATOR

Low fluoride and conventional dentifrices with different pH

Intervention Type OTHER

Comparison of different dentifrice fluoride concentrations and pH on caries control

Caries-active 550 ppm F, pH 4.5

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.

Group Type ACTIVE_COMPARATOR

Low fluoride and conventional dentifrices with different pH

Intervention Type OTHER

Comparison of different dentifrice fluoride concentrations and pH on caries control

Caries-active 1100 ppm F, pH 7.0

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.

Group Type ACTIVE_COMPARATOR

Low fluoride and conventional dentifrices with different pH

Intervention Type OTHER

Comparison of different dentifrice fluoride concentrations and pH on caries control

Caries-inactive 550 ppm F, pH 7.0

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.

Group Type ACTIVE_COMPARATOR

Low fluoride and conventional dentifrices with different pH

Intervention Type OTHER

Comparison of different dentifrice fluoride concentrations and pH on caries control

Caries-inactive 550 ppm F, pH 4.5

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.

Group Type ACTIVE_COMPARATOR

Low fluoride and conventional dentifrices with different pH

Intervention Type OTHER

Comparison of different dentifrice fluoride concentrations and pH on caries control

Interventions

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Low fluoride and conventional dentifrices with different pH

Comparison of different dentifrice fluoride concentrations and pH on caries control

Intervention Type OTHER

Other Intervention Names

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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)

Eligibility Criteria

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Inclusion Criteria

* \>= 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

Exclusion Criteria

* Using orthodontic appliances
Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Marilia Afonso Rabelo Buzalaf

Chair professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marília AR Buzalaf, PhD

Role: PRINCIPAL_INVESTIGATOR

Bauru Dental School, University of São Paulo

Locations

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Public primary schools in Bauru

Bauru, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 23873319 (View on PubMed)

Other Identifiers

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USP0162009

Identifier Type: -

Identifier Source: org_study_id