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Effect of pH, Consistency and Concentration of Fluoride in Toothpaste in the Caries Control

2014-08-27 03:16:39 | BioPortfolio

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. Additionally,the investigators will also evaluate the effect of the consistency of toothpaste on the biofilm incorporation of F. Both studies will be divided into: Part I - 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. In half of the sample will be collected nails and dental biofilm for analysis of fluoride content. 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 and the evaluation of the concentration of fluoride incorporated into the biofilm will be done 6 months after initiation of use of toothpaste. Samples of plaque will be analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). The presence of F will be analyzed as described above. For statistical analysis will be used ANOVA and test for individual comparisons. Part II - A randomized double-blind crossover study will be carried out with 25 children with 8 to 10 years old, of public schools. The factor under study is the incorporation of F in dental biofilm on two levels (1 h and 12 h after brushing), and fluidity of toothpaste at 3 levels (low, medium and high). The dependent variable is the concentration of F incorporated into the dental biofilm. The study will be done in 3 successive stages, each lasting one week, separated by an interval of 2 weeks, when volunteers will use liquid dentifrice without F (wash-out). The evaluation of the concentration of F in the biofilm, as well as statistical analysis will be made as described in Part I.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Conditions

Dental Fluoroses

Intervention

Fluoride intake

Location

Bauru Dental School, University of São Paulo
Bauru
São Paulo
Brazil
17012-901

Status

Enrolling by invitation

Source

University of Sao Paulo

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:39-0400

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Poisoning that results from chronic or acute ingestion, injection, inhalation, or skin absorption of FLUORIDE compounds.

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