Effect of the Amount of Fluoride Toothpaste on Fluoride Availability in the Oral Fluids in Children
27. februar 2018 opdateret af: Livia Maria Andaló Tenuta, University of Campinas, Brazil
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Fase 4
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 år til 3 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- All children with an informed consent signed by the parents/guardians
Exclusion Criteria:
- Children with at least on active caries lesion
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: 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)
|
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
|
|
Eksperimentel: 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
|
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
|
|
Eksperimentel: 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
|
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
|
|
Eksperimentel: 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
|
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
|
|
Aktiv komparator: 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)
|
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Fluoride concentration in saliva before brushing
Tidsramme: Before brushing (baseline)
|
Before brushing (baseline)
|
|
Fluoride concentration in saliva 5 min after brushing
Tidsramme: 5 minutes after brushing
|
5 minutes after brushing
|
|
Fluoride concentration in saliva 15 min after brushing
Tidsramme: 15 min after brushing
|
15 min after brushing
|
|
Fluoride concentration in saliva 30 min after brushing
Tidsramme: 30 min after brushing
|
30 min after brushing
|
|
Fluoride concentration in dental biofilm (fluid fraction) before brushing
Tidsramme: Before brushing (baseline)
|
Before brushing (baseline)
|
|
Fluoride concentration in dental biofilm (fluid fraction) 30 min after brushing
Tidsramme: 30 min after brushing
|
30 min after brushing
|
|
Fluoride concentration in dental biofilm (solid fraction) before brushing
Tidsramme: Before brushing (baseline)
|
Before brushing (baseline)
|
|
Fluoride concentration in dental biofilm (solid fraction) 30 min after brushing
Tidsramme: 30 min after brushing
|
30 min after brushing
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2010
Primær færdiggørelse (Faktiske)
31. december 2010
Studieafslutning (Faktiske)
30. juni 2011
Datoer for studieregistrering
Først indsendt
21. februar 2018
Først indsendt, der opfyldte QC-kriterier
27. februar 2018
Først opslået (Faktiske)
6. marts 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FOPBioq007
Plan for individuelle deltagerdata (IPD)
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