- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03761485
Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dentifrice 750 ppm of NaF acidulated
Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months
|
Use of few of dentifrice on brushing during a year
|
ACTIVE_COMPARATOR: Dentifrice 1.100 ppm of NaF neutral
Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months
|
Use of few of dentifrice on brushing during a year
|
ACTIVE_COMPARATOR: Dentifrice 1.100 ppm of NaF acidulated
Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months
|
Use of few of dentifrice on brushing during a year
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of intraoral fluoride
Time Frame: 1 year
|
Effective of capacity to concentration of fluoride in biofilm (ppm)
|
1 year
|
Effect of intraoral fluoride - software
Time Frame: 1 year
|
Reduction of initial lesions carie give by mm² analysed by software
|
1 year
|
Effect of intraoral fluoride
Time Frame: 1 year
|
Reduction of initial lesions carie give by visual scale (Nyvad scale)
|
1 year
|
Concentration of nail fluorid
Time Frame: 1 year
|
Concentration of fluoride in nail (ppm)
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acidulated fluoride dentifrice
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Caries, Dental
-
Ain Shams UniversityCompletedPulpitis | Caries | Caries,Dental | Reversible Pulpitis | Caries Class I | Caries; DentinEgypt
-
National University of San Marcos, PeruNot yet recruitingPit and Fissure Caries | Caries,Dental | Sealant DentalPeru
-
University of MinnesotaCompletedUsing Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood CariesCaries | Caries,DentalUnited States
-
3MUniversity of MichiganActive, not recruiting
-
Hue University of Medicine and PharmacyRecruitingOcclusal Caries | Caries,Dental | Caries; InitialVietnam
-
Rawda Hesham Abd ElAzizRecruitingCaries,Dental | Caries Class IIEgypt
-
The University of Texas Health Science Center,...National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCaries,DentalUnited States
-
Federal University of PelotasRecruiting
-
Kompetansesenteret Tannhelse Midt (TkMidt)Karolinska Institutet; University of Bergen; Norwegian University of Science... and other collaboratorsActive, not recruiting
-
Marmara UniversityCompleted
Clinical Trials on Use of Dentifrice Fluoride
-
Procter and GambleCompleted
-
Procter and GambleCompleted
-
Federal University of ParaíbaCompleted
-
Colgate PalmoliveActive, not recruiting
-
Pearl NetworkCompleted
-
Federal University of ParaíbaConselho Nacional de Desenvolvimento Científico e Tecnológico; Coordination...Completed
-
Colgate PalmoliveCompleted
-
Procter and GambleCompleted
-
Procter and GambleCompleted
-
GlaxoSmithKlineCompleted