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Evaluation in Vivo of Mouthwash With Nanoencapsulated Fluoride

NCT05143086 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-12-03

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 mouthwashes is shown as an effective way to increase the fluoride intraoral availability. However, the current challenge is the substantivity, so new compounds have been introduced into these formulations. This study aims to evaluate the in vivo effect of fluoride mouthwash containing nanoencapsulated Fluoride (NanoF) - 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 rinsing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. It will be 3 mouthwashes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride and Free sodium fluoride. Between weeks of use, rinsing 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

Mouthwash 100% Nano-F

Use 10 ml of mouthwash 100% Nanoencapsulated Fluoride after brushing for one week, twice a day.

OTHER

Mouthwash 50% Nano-F

Use 10 ml of mouthwash 50% Nanoencapsulated Fluoride after brushing for one week, twice a day.

OTHER

Mouthwash standard

Use 10 ml of mothwash after brushing for one week, twice a day. It's for the positive control of fluoride.

OTHER

Placebo

Use 10 ml of mouthwash without fluoride

Sponsors & Collaborators

  • Fabio Correia Sampaio

    lead OTHER

Principal Investigators

  • Fábio Sampaio · 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
2016-11-01
Primary Completion
2017-11-15
Completion
2017-12-20

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 NCT05143086 on ClinicalTrials.gov