Caries, Dental Clinical Trial
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
Verified date | November 2018 |
Source | Federal University of Paraíba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 452 |
Est. completion date | January 15, 2018 |
Est. primary completion date | January 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 4 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federal University of Paraíba |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of intraoral fluoride | Effective of capacity to concentration of fluoride in biofilm (ppm) | 1 year | |
Primary | Effect of intraoral fluoride - software | Reduction of initial lesions carie give by mm² analysed by software | 1 year | |
Primary | Effect of intraoral fluoride | Reduction of initial lesions carie give by visual scale (Nyvad scale) | 1 year | |
Primary | Concentration of nail fluorid | Concentration of fluoride in nail (ppm) | 1 year |
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