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

Phase 4
Completed
Conditions
Dental Caries
Interventions
Procedure: Toothbrushing
Registration Number
NCT03455621
Lead Sponsor
University of Campinas, Brazil
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria
  • All children with an informed consent signed by the parents/guardians
Exclusion Criteria
  • Children with at least on active caries lesion

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
0.025 g of 1,100 ppm F dentifriceToothbrushingFluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.025 g
0.05 g of 1,100 ppm F dentifriceToothbrushingFluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.05 g
0.1 g of 1,100 ppm F dentifriceToothbrushingFluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.1 g
Pea-size amount of 1,100 ppm F dentifriceToothbrushingFluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.3 g (pea-size amount)
Pea-size amount of non-F dentifriceToothbrushingNon-fluoride dentifrice (0 ppm F); to be used twice/day. Amount to be used: 0.3 g (pea-size amount)
Primary Outcome Measures
NameTimeMethod
Fluoride concentration in dental biofilm (fluid fraction) 30 min after brushing30 min after brushing
Fluoride concentration in saliva before brushingBefore brushing (baseline)
Fluoride concentration in saliva 15 min after brushing15 min after brushing
Fluoride concentration in saliva 30 min after brushing30 min after brushing
Fluoride concentration in dental biofilm (solid fraction) 30 min after brushing30 min after brushing
Fluoride concentration in saliva 5 min after brushing5 minutes after brushing
Fluoride concentration in dental biofilm (fluid fraction) before brushingBefore brushing (baseline)
Fluoride concentration in dental biofilm (solid fraction) before brushingBefore brushing (baseline)
Secondary Outcome Measures
NameTimeMethod
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