Clinical Trials Directory

Trials / Completed

CompletedNCT03455621

Effect of the Amount of Fluoride Toothpaste on Fluoride Availability in the Oral Fluids in Children

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
15 (actual)
Sponsor
University of Campinas, Brazil · Academic / Other
Sex
All
Age
18 Months – 42 Months
Healthy volunteers
Accepted

Summary

The aim of the study is to determine the fluoride availability in saliva and dental biofilm after the use of increasing amounts of fluoride toothpaste. Using a crossover and blind design, 15 children (18-42 months old) had their teeth brushed with increasing amounts of fluoride toothpaste. Fluoride concentration in saliva and dental biofilm was determined up to 30 min after brushing.

Detailed description

The aim of the study is to determine the fluoride availability in saliva and dental biofilm after the use of increasing amounts of fluoride toothpaste. Children from 18 to 42 months from a community daycare participated. The study had a crossover and blind design. The amounts of toothpastes tested were: 1. A pea-size amount (0.3 g) of a non-F toothpaste; 2. 0.025 g of a F toothpaste (1,100 ppm F, as NaF); 3. 0.05 g of the same F toothpaste; 4. 0.1 g of the same F toothpaste; or 5. 0.3 g (pea-size) of the same F toothpaste. Children were to brush their teeth with the designated amount of toothpaste twice/day from Monday to Friday. In order to allow biofilm accumulation, caregivers were instructed to brush only the occlusal surfaces of primary molars. On Friday morning, at least one hour after breakfast, saliva and one biofilm sample from the right or left hemiarch were collected and analyzed for fluoride concentration. Then, brushing with the respective amount of toothpaste was performed, and saliva was collected 5, 15 and 30 min later. The biofilm from the other side of the mouth was collected after 30 min. Fluoride concentration in saliva and biofilm samples was determined with an ion-specific electrode.

Conditions

Interventions

TypeNameDescription
PROCEDUREToothbrushingToothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)

Timeline

Start date
2010-03-01
Primary completion
2010-12-31
Completion
2011-06-30
First posted
2018-03-06
Last updated
2018-03-06

Source: ClinicalTrials.gov record NCT03455621. Inclusion in this directory is not an endorsement.