Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice
Condition: Caries, Dental; Fluorosis, Dental
MeSH terms: Dental Caries; Fluorosis, Dental; Fluoride Poisoning
Study type: Interventional
Phase: Phase 4

Summary: 
      This research aimed to evaluate the risk of dental fluorosis by using an experimental
      fluoridated acidulated dentifrice compared to conventional dentifrices in
      two-to-four-year-old children residing in a non fluoridated area by the concentration of
      fluoride incorporated in childrens' nails, as well as the incorporation of F into the
      biofilm. Two hundred and ten children participated on this study. They were randomly
      allocated into three groups differing according to the type of dentifrice used over 12
      months: G1:1100 ppm F, pH 4.5; G2:750 ppm F, pH 4.5; G3:1100 ppm F, pH 7.0. The dentifrice
      was placed on the toothbrush using the "drop" technique. The toenails of the biggest toe were
      collected in three moments, corresponding to the experimental period of use of the
      dentifrices (T1, T2 and T3), as well as the biofilm which was collected twice, 5 and 60
      minutes after brushing. The nails and biofilm fluoride concentration were analyzed on a
      specific electrode using the HMDS diffusion facilitated technique.
    

Detailed description: 
      This is a randomized, double-blind, interventional trial, adopting a strategy for collecting
      data, collecting data from the children's biofilm. This study was carried out in three Child
      Education Reference Centers (CREIs) located in different points of the city of João Pessoa
      PB.

      The city is located in the Northeast region of Brazil, on the coast of the state of Paraíba
      and has about 600 thousand inhabitants (IBGE, 2013). João Pessoa has already had fluoridated
      water for a period of two years until the mid-1980s, but so far the project has been
      deactivated.

      The 452 children participating in the study were divided into three groups according to the
      dentifrice used in a 12 - month period: G1: 1,100 ppm F - pH 4.5; G2: 750 ppm F-pH 4.5; and
      G3: 1100 ppm F-pH 7.0. The toothpaste was supplied by Oralls (São Jose dos Campos-SP, Brazil)
      and dental brushes by Bitufo (Hypermarcas, São Paulo, SP-, Brazil) and there was no conflict
      of interest. For the random distribution of the groups, the CREIs were considered as units,
      so that only one type of toothpaste was distributed in each CREI, thus facilitating the
      control of the dentifrices delivery by the teachers, as well as the supervised brushing in
      CREI itself.

      The toenails of the biggest toe were collected in three moments, corresponding to the
      experimental period of use of the dentifrices (T1, T2 and T3), as well as the biofilm which
      was collected twice, 5 and 60 minutes after brushing. The nails and biofilm fluoride
      concentration were analyzed on a specific electrode using the HMDS diffusion facilitated
      technique.

      Nails of the large toes were collected because they provide a sufficient nail mass for
      analysis and because there has been a reported possibility of contamination of the toenails
      (Buzalaf, Pessan et al., 2006). The nail samples of each child were cleaned with deionized
      water using a dental brush, taken to the ultrasound apparatus with deionized water for 10
      min, dried at 60 ± 5 ° C and weighed on the analytical balance The presence of F was analyzed
      as described in the previous item, according to the method of Taves (1968), as modified by
      Whitford (1996). F patterns (0.00475, 0.0095, 0.019, 0.095, 0.190 and 0.95 mg F) were
      prepared by serial dilution of a stock solution of 0.1 MF (Orion) in triplicate and diffused
      in the same manner as the samples. The average repeatability of the readings based on
      duplicate samples was 95%. Whenever the sample weight was> 20 mg, the analysis was performed
      in duplicate.
    

Intervention name(s): Use of Dentifrice Fluoride
Intervention type(s): Other
Intervention description(s): Use of few of dentifrice on brushing during a year
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double blind clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment