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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: Toothbrushing

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Children with at least on active caries lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Pea-size amount of non-F dentifrice; Non-fluoride dentifrice (0 ppm F); to be used twice/day. Amount to be used: 0.3 g (pea-size amount)	Procedure: Toothbrushing; Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
Experimental: 0.025 g of 1,100 ppm F dentifrice; Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.025 g	Procedure: Toothbrushing; Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
Experimental: 0.05 g of 1,100 ppm F dentifrice; Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.05 g	Procedure: Toothbrushing; Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
Experimental: 0.1 g of 1,100 ppm F dentifrice; Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day. Amount to be used: 0.1 g	Procedure: Toothbrushing; Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
Active Comparator: Pea-size amount of 1,100 ppm F dentifrice; 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; Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): December 31, 2010
• Study Completion (Actual): June 30, 2011

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: fluoride; dental caries; dentifrice; toothpaste
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: FOPBioq007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No