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

NCT03455621 | Completed Phase 4

• 1 other identifier: FOPBioq007
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries

Keywords

dental caries; fluoride; toothpaste; dentifrice

Outcome Measures

Primary Outcomes (8)

• Fluoride concentration in saliva before brushing

  Before brushing (baseline)

• Fluoride concentration in saliva 5 min after brushing

  5 minutes after brushing

• Fluoride concentration in saliva 15 min after brushing

  15 min after brushing

• Fluoride concentration in saliva 30 min after brushing

  30 min after brushing

• Fluoride concentration in dental biofilm (fluid fraction) before brushing

  Before brushing (baseline)

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

  30 min after brushing

• Fluoride concentration in dental biofilm (solid fraction) before brushing

  Before brushing (baseline)

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

  30 min after brushing

Study Arms (5)

Pea-size amount of non-F dentifrice

PLACEBO COMPARATOR

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

Procedure: Toothbrushing

0.025 g of 1,100 ppm F dentifrice

EXPERIMENTAL

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

Procedure: Toothbrushing

0.05 g of 1,100 ppm F dentifrice

EXPERIMENTAL

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

Procedure: Toothbrushing

0.1 g of 1,100 ppm F dentifrice

EXPERIMENTAL

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

Procedure: Toothbrushing

Pea-size amount of 1,100 ppm F dentifrice

ACTIVE COMPARATOR

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

Procedure: Toothbrushing

Interventions

Toothbrushing PROCEDURE

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

0.025 g of 1,100 ppm F dentifrice; 0.05 g of 1,100 ppm F dentifrice; 0.1 g of 1,100 ppm F dentifrice; Pea-size amount of 1,100 ppm F dentifrice; Pea-size amount of non-F dentifrice

Eligibility Criteria

• Age: 18 Months - 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children with at least on active caries lesion

Sponsors & Collaborators

• University of Campinas, Brazil: lead

MeSH Terms

Conditions

Dental Caries

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: March 6, 2018
• Study Start: March 1, 2010
• Primary Completion: December 31, 2010
• Study Completion: June 30, 2011
• Last Updated: March 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share