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Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice

Primary Purpose

Caries, Dental, Fluorosis, Dental

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Use of Dentifrice Fluoride
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries, Dental

Eligibility Criteria

2 Years - 4 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age group of 2 to 4 years of age of both sexes
  • Who were enrolled in one of the 3 CREIs that participated in the research
  • Presence of deciduos teeth

Exclusion Criteria:

  • Presented high mobility of the children (incompatible with the planning of a longitudinal study)
  • Children who did not allow the clinical examination in the school
  • Children using orthodontic appliances or children with extensive caries lesions with dentin sensitivity
  • Children not residing in the city of João Pessoa-PB from birth to 4 years due to the fluoridation of water from public supply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Dentifrice 750 ppm of NaF acidulated

    Dentifrice 1.100 ppm of NaF neutral

    Dentifrice 1.100 ppm of NaF acidulated

    Arm Description

    Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months

    Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months

    Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months

    Outcomes

    Primary Outcome Measures

    Concentration of intraoral fluoride
    Effective of capacity to concentration of fluoride in biofilm (ppm)
    Effect of intraoral fluoride - software
    Reduction of initial lesions carie give by mm² analysed by software
    Effect of intraoral fluoride
    Reduction of initial lesions carie give by visual scale (Nyvad scale)
    Concentration of nail fluorid
    Concentration of fluoride in nail (ppm)

    Secondary Outcome Measures

    Full Information

    First Posted
    August 25, 2018
    Last Updated
    November 30, 2018
    Sponsor
    Federal University of Paraíba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03761485
    Brief Title
    Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice
    Official Title
    Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice: Clinical Trial - Epidemiological Study With Children Residing in an área Without Public Water Fluoridation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 15, 2015 (Actual)
    Primary Completion Date
    January 15, 2018 (Actual)
    Study Completion Date
    January 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Paraíba

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caries, Dental, Fluorosis, Dental

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized double blind clinical trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    double blind
    Allocation
    Randomized
    Enrollment
    452 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dentifrice 750 ppm of NaF acidulated
    Arm Type
    Experimental
    Arm Description
    Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months
    Arm Title
    Dentifrice 1.100 ppm of NaF neutral
    Arm Type
    Active Comparator
    Arm Description
    Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months
    Arm Title
    Dentifrice 1.100 ppm of NaF acidulated
    Arm Type
    Active Comparator
    Arm Description
    Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months
    Intervention Type
    Other
    Intervention Name(s)
    Use of Dentifrice Fluoride
    Intervention Description
    Use of few of dentifrice on brushing during a year
    Primary Outcome Measure Information:
    Title
    Concentration of intraoral fluoride
    Description
    Effective of capacity to concentration of fluoride in biofilm (ppm)
    Time Frame
    1 year
    Title
    Effect of intraoral fluoride - software
    Description
    Reduction of initial lesions carie give by mm² analysed by software
    Time Frame
    1 year
    Title
    Effect of intraoral fluoride
    Description
    Reduction of initial lesions carie give by visual scale (Nyvad scale)
    Time Frame
    1 year
    Title
    Concentration of nail fluorid
    Description
    Concentration of fluoride in nail (ppm)
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age group of 2 to 4 years of age of both sexes Who were enrolled in one of the 3 CREIs that participated in the research Presence of deciduos teeth Exclusion Criteria: Presented high mobility of the children (incompatible with the planning of a longitudinal study) Children who did not allow the clinical examination in the school Children using orthodontic appliances or children with extensive caries lesions with dentin sensitivity Children not residing in the city of João Pessoa-PB from birth to 4 years due to the fluoridation of water from public supply.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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