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Completed

NCT Number: NCT03455621

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 month–42 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children with at least on active caries lesion

Treatment and study plan

Toothbrushing

Procedure

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

Primary outcomes

  1. Fluoride concentration in saliva before brushing

    Time frame: Before brushing (baseline)

  2. Fluoride concentration in saliva 5 min after brushing

    Time frame: 5 minutes after brushing

  3. Fluoride concentration in saliva 15 min after brushing

    Time frame: 15 min after brushing

  4. Fluoride concentration in saliva 30 min after brushing

    Time frame: 30 min after brushing

  5. Fluoride concentration in dental biofilm (fluid fraction) before brushing

    Time frame: Before brushing (baseline)

  6. Fluoride concentration in dental biofilm (fluid fraction) 30 min after brushing

    Time frame: 30 min after brushing

  7. Fluoride concentration in dental biofilm (solid fraction) before brushing

    Time frame: Before brushing (baseline)

  8. Fluoride concentration in dental biofilm (solid fraction) 30 min after brushing

    Time frame: 30 min after brushing

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 6, 2018
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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