Nanosilver Fluoride to Prevent Dental Biofilms Growth

NCT ID: NCT01950546

Last Updated: 2015-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-01-31

Brief Summary

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This study aims to evaluate the effectiveness of nanosilver fluoride for controlling the growth of S. mutans present in dental plaque of children.

Detailed Description

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The product will be apllied on cervical vestibular surfaces of incisors and canines healthy, with a total of 8 teeth, 4 upper and 4 below. Children will be instructed not to ingest any liquid or food within two hours after application. After a period of 7 days will be carried biofilm colect of cervical dental surfaces of incisors and / or canines upper and lower, with the aid of sterile spatulas. This material will be packaged in pre-weighed microfuge tubes containing 1.5 ml of buffered saline solution (0.9% sodium chloride), and transported under refrigeration immediately to the laboratory where analysis will be performed and the S. mutans colonies will be counted. The biofilm collect and posterior laboratorial analysis will be performed weekly.

Conditions

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Dental Caries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nanosilver fluoride

This product is a solution composed of: 390 mg / ml 9nm silver nanoparticles ;21 mg / ml chitosan ; 22 mg / ml NaF.The cariostatic agent, nanosilver fluoride, was formulated in a similar way to silver diamine fluoride, so that this new formulation contained 5% nanosilver fluoride, while commercial diamine silver fluoride contains 30% silver fluoride. It will be applied once with a microbrush on tooth surfaces to check if it prevents the growth of S. mutans biofilms on dental surfaces.

Group Type EXPERIMENTAL

nanosilver fluoride

Intervention Type DRUG

The product will be applied in the volunteers in the morning, before the first class, in relative isolation, made with cotton rolls and Vaseline to protect the soft tissue. It will apply 30mg of the product with microbrush, previously standardized in a pilot study on cervical vestibular surfaces of incisors and canines healthy, on a total of 8 teeth, 4 upper and 4 lower. After a period of 7 days,the cervical dental biofilms will be collect, third on the buccal surfaces of incisors and / or canines upper and lower, with the aid of sterile spatulas.

Interventions

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nanosilver fluoride

The product will be applied in the volunteers in the morning, before the first class, in relative isolation, made with cotton rolls and Vaseline to protect the soft tissue. It will apply 30mg of the product with microbrush, previously standardized in a pilot study on cervical vestibular surfaces of incisors and canines healthy, on a total of 8 teeth, 4 upper and 4 lower. After a period of 7 days,the cervical dental biofilms will be collect, third on the buccal surfaces of incisors and / or canines upper and lower, with the aid of sterile spatulas.

Intervention Type DRUG

Other Intervention Names

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silver nanoparticles

Eligibility Criteria

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Inclusion Criteria

* Have at least 4 upper teeth and 4 lower teeth deciduous;systemic health satisfactory; did not use antibiotics or nonsteroidal anti-inflammatory within one month before or during the study;do not use any other forms of chemical control of biofilm during the study period;not being a user of orthodontic devices or dentures;

Exclusion Criteria

* Presenting oral lesions, supragingival calculus and severe malocclusion.
Minimum Eligible Age

5 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

University of Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Priscila Lima de Luna Freire

Msc, School of Dentistry, University of Pernambuco,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aronita Rosenblatt, PhD

Role: STUDY_DIRECTOR

UPE

Locations

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Escola Municipal Anita Trigueiro do Valle

João Pessoa, Paraíba, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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FOP01

Identifier Type: -

Identifier Source: org_study_id

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