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Evaluation in Vivo of Dentifrice With Nanoencapsulated Fluoride

NCT03008759 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-01-02

No results posted yet for this study

Summary

The literature recognizes that fluoride is the most widely used and studied means for dental remineralization. The use of fluoride toothpaste in brushing is considered more rational method for the prevention of caries. However, the current challenge of toothpaste is the substantivity, so new compounds have been introduced into these formulations. This study aims to evaluate the in vivo effect of fluoride dentifrice containing nanoencapsulated Fluoride (Nano-F) - in fluoride retention in saliva and dental plaque. A study of the clinical and laboratory type, crossover, double-blind, randomized will be held. After sample calculation, the total of 12 individuals aged between 18 and 35 years old, healthy, decayed, missing, and filled teeth index less than 6 and residents in brazilian northeast capital will be part of the sample. Fluoride bioavailability will be evaluated in the biofilm and saliva after the use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h after brushing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. It will be 3 toothpastes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride and Free sodium fluoride. Between weeks of use, brushing will be extended washout (without fluoride) to avoid carryover effect. inferential data analysis will be carried out, considering the amount of alpha \<0.05. So knowing that caries is a dynamic process, the largest fluoride retention in the oral fluids promoted by the Nanoencapsulated Fluoride may have important impact on Des-Re process and in the control of dental caries

Conditions

  • Dental Caries

Interventions

OTHER

Dentifrice 100% Nano-F

Use of few of dentifrice 100% Nanoencapsulated Fluoride on brushing for one week, twice day.

OTHER

Dentifrice 50% Nano-F

Use of few of dentifrice 50% Nanoencapsulated Fluoride on brushing for one week, twice day.

OTHER

Dentifrice standard

Use of few of dentifrice on brushing for one week, twice day. It's for the positive control of fluorid

Sponsors & Collaborators

  • Fabio Correia Sampaio

    lead OTHER

Principal Investigators

  • Fábio Sampaio, Doctor · University Federal of Paraiba

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
32 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-11-30
Completion
2017-02-28

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03008759 on ClinicalTrials.gov