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
About this trial
This is an interventional treatment trial for Caries, Dental
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.
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
NCT ID
NCT03761485
First Posted
August 25, 2018
Last Updated
November 30, 2018
Sponsor
Federal University of Paraíba
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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Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice
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