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

Study Overview
=================
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.

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

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Procedure: Toothbrushing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 42 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental caries, fluoride, toothpaste, dentifrice