Effect of pH and Fluoride Concentration of Dentifrices on Caries Control (EPHFCDCC)

University of Sao Paulo

Status and phase: Completed; Phase 3

Conditions: Dental Fluorosis; Dental Caries

Treatments: Other: Low fluoride and conventional dentifrices with different pH

Study type: Interventional

Funder types: Other

Identifiers

NCT01049503

USP0162009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 315 patients

Sex: All

Ages: 2 to 4 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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315 participants in 6 patient groups

Caries-active 550 ppm F, pH 7.0

Active Comparator group

Description:

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.

Treatment:

Other: Low fluoride and conventional dentifrices with different pH

Caries-active 550 ppm F, pH 4.5

Active Comparator group

Description:

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.

Treatment:

Other: Low fluoride and conventional dentifrices with different pH

Caries-active 1100 ppm F, pH 7.0

Active Comparator group

Description:

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.

Treatment:

Other: Low fluoride and conventional dentifrices with different pH

Caries-inactive 550 ppm F, pH 7.0

Active Comparator group

Description:

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.

Treatment:

Other: Low fluoride and conventional dentifrices with different pH

Caries-inactive 550 ppm F, pH 4.5

Active Comparator group

Description:

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.

Treatment:

Other: Low fluoride and conventional dentifrices with different pH

Caries-inactive 1100 ppm F, pH 7.0

Active Comparator group

Description:

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.

Treatment:

Other: Low fluoride and conventional dentifrices with different pH