Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice

NCT03761485 | Completed Phase 4

• 1 other identifier: Acidulated fluoride dentifrice
• Study Type: interventional
• Target: 452
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caries, Dental; Fluorosis, Dental

Outcome Measures

Primary Outcomes (4)

• Concentration of intraoral fluoride

  Effective of capacity to concentration of fluoride in biofilm (ppm)

  1 year

• Effect of intraoral fluoride - software

  Reduction of initial lesions carie give by mm² analysed by software

  1 year

• Effect of intraoral fluoride

  Reduction of initial lesions carie give by visual scale (Nyvad scale)

  1 year

• Concentration of nail fluorid

  Concentration of fluoride in nail (ppm)

  1 year

Study Arms (3)

Dentifrice 750 ppm of NaF acidulated

EXPERIMENTAL

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

Other: Use of Dentifrice Fluoride

Dentifrice 1.100 ppm of NaF neutral

ACTIVE COMPARATOR

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

Other: Use of Dentifrice Fluoride

Dentifrice 1.100 ppm of NaF acidulated

ACTIVE COMPARATOR

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

Other: Use of Dentifrice Fluoride

Interventions

Use of Dentifrice Fluoride OTHER

Use of few of dentifrice on brushing during a year

Dentifrice 1.100 ppm of NaF acidulated; Dentifrice 1.100 ppm of NaF neutral; Dentifrice 750 ppm of NaF acidulated

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

MeSH Terms

Conditions

Dental Caries; Fluorosis, Dental

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized double blind clinical trial

Study Record Dates

• First Submitted: August 25, 2018
• First Posted: December 3, 2018
• Study Start: January 15, 2015
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: December 3, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share