Effect of pH and Fluoride Concentration of Dentifrices on Caries Control
Condition: Dental Fluorosis; Dental Caries
MeSH terms: Dental Caries; Fluorosis, Dental
Study type: Interventional
Phase: Phase 3

Summary: 
      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: 
      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.
    

Intervention name(s): Low fluoride and conventional dentifrices with different pH
Intervention type(s): Other
Intervention description(s): Comparison of different dentifrice fluoride concentrations and pH on caries control
Other intervention name(s): 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)
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dentifrices; Fluoride; Nails; Plaque