Clinical trial NCT03455621: Effect of the Amount of Fluoride Toothpaste on Fluoride Availability in the Oral Fluids in Children
Official title: Effect of the Amount of Fluoride Toothpaste on Fluoride Availability in the Oral Fluids in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Keywords: dental caries
fluoride
toothpaste
dentifrice
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All children with an informed consent signed by the parents/guardians

Exclusion Criteria:

* Children with at least on active caries lesion

Primary outcomes:
measure: Fluoride concentration in saliva before brushing
timeFrame: Before brushing (baseline)
measure: Fluoride concentration in saliva 5 min after brushing
timeFrame: 5 minutes after brushing
measure: Fluoride concentration in saliva 15 min after brushing
timeFrame: 15 min after brushing
measure: Fluoride concentration in saliva 30 min after brushing
timeFrame: 30 min after brushing
measure: Fluoride concentration in dental biofilm (fluid fraction) before brushing
timeFrame: Before brushing (baseline)
measure: Fluoride concentration in dental biofilm (fluid fraction) 30 min after brushing
timeFrame: 30 min after brushing
measure: Fluoride concentration in dental biofilm (solid fraction) before brushing
timeFrame: Before brushing (baseline)
measure: Fluoride concentration in dental biofilm (solid fraction) 30 min after brushing
timeFrame: 30 min after brushing
Secondary outcomes:
Other outcomes:
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