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

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Dental Caries

Treatments: Procedure: Toothbrushing

Study type: Interventional

Funder types: Other

Identifiers

NCT03455621

FOPBioq007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 42 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Children with at least on active caries lesion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 5 patient groups, including a placebo group

Pea-size amount of non-F dentifrice

Placebo Comparator group

Description:

Non-fluoride dentifrice (0 ppm F); to be used twice/day. Amount to be used: 0.3 g (pea-size amount)

Treatment:

Procedure: Toothbrushing

0.025 g of 1,100 ppm F dentifrice

Experimental group

Description:

Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.025 g

Treatment:

Procedure: Toothbrushing

0.05 g of 1,100 ppm F dentifrice

Experimental group

Description:

Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.05 g

Treatment:

Procedure: Toothbrushing

0.1 g of 1,100 ppm F dentifrice

Experimental group

Description:

Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.1 g

Treatment:

Procedure: Toothbrushing

Pea-size amount of 1,100 ppm F dentifrice

Active Comparator group

Description:

Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.3 g (pea-size amount)

Treatment:

Procedure: Toothbrushing