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

Primary Purpose

Dental Caries

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Toothbrushing

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring dental caries, fluoride, toothpaste, dentifrice

Eligibility Criteria

18 Months - 42 Months (Child)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Pea-size amount of non-F dentifrice

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

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Fluoride concentration in saliva before brushing

Fluoride concentration in saliva 5 min after brushing

Fluoride concentration in saliva 15 min after brushing

Fluoride concentration in saliva 30 min after brushing

Fluoride concentration in dental biofilm (fluid fraction) before brushing

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

Fluoride concentration in dental biofilm (solid fraction) before brushing

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03455621

First Posted

February 21, 2018

Last Updated

February 27, 2018

Sponsor

University of Campinas, Brazil

1. Study Identification

Unique Protocol Identification Number

NCT03455621

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

March 1, 2010 (Actual)

Primary Completion Date

December 31, 2010 (Actual)

Study Completion Date

June 30, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Campinas, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

dental caries, fluoride, toothpaste, dentifrice

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pea-size amount of non-F dentifrice

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

0.025 g of 1,100 ppm F dentifrice

Arm Type

Experimental

Arm Description

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

Arm Title

0.05 g of 1,100 ppm F dentifrice

Arm Type

Experimental

Arm Description

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

Arm Title

0.1 g of 1,100 ppm F dentifrice

Arm Type

Experimental

Arm Description

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

Arm Title

Pea-size amount of 1,100 ppm F dentifrice

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Toothbrushing

Intervention Description

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

Primary Outcome Measure Information:

Title

Fluoride concentration in saliva before brushing

Time Frame

Before brushing (baseline)

Title

Fluoride concentration in saliva 5 min after brushing

Time Frame

5 minutes after brushing

Title

Fluoride concentration in saliva 15 min after brushing

Time Frame

15 min after brushing

Title

Fluoride concentration in saliva 30 min after brushing

Time Frame

30 min after brushing

Title

Fluoride concentration in dental biofilm (fluid fraction) before brushing

Time Frame

Before brushing (baseline)

Title

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

Time Frame

30 min after brushing

Title

Fluoride concentration in dental biofilm (solid fraction) before brushing

Time Frame

Before brushing (baseline)

Title

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

Time Frame

30 min after brushing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Months

Maximum Age & Unit of Time

42 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All children with an informed consent signed by the parents/guardians Exclusion Criteria: Children with at least on active caries lesion

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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