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Completed

NCT Number: NCT01950546

Nanosilver Fluoride to Prevent Dental Biofilms Growth

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

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Escola Municipal Anita Trigueiro do Valle

João Pessoa, Paraíba, 58046020, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nanosilver fluoride

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.

Other names: silver nanoparticles

Primary outcomes

  1. Initial biofilm collecting before applying the product and after nanosilver fluoride application.

    Time frame: one week

    The initial dental biofilm collection will be conducted to count colony-forming units of S. mutans and then the product will be applied on these dental surfaces after the collect. After one week, a new collect will be performed and the colony-forming units of S. mutans will be counting to compare with the initial.

Secondary outcomes

  1. Evaluation of effectiveness of nanosilver fluoride on bacterial growth in the dental biofilm

    Time frame: two weeks

    Collection of dental biofilm will be performed after two weeks of product application and colony count will be performed in the laboratory.

Other outcomes

  1. Collection of dental biofilm will after four weeks of product application.

    Time frame: Four weeks

    Collection of dental biofilm will be performed after four weeks of product application and colony count will be performed in the laboratory.

  2. Collection of dental biofilm after eight weeks of product application

    Time frame: Eight weeks

    Collection of dental biofilm will be performed after eight weeks of product application and will be compared with the initial score of S. mutans colony forming units.

Sponsors and collaborators

Lead sponsor

University of Pernambuco

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

Nanosilver Fluoride: a Microbiological and Clinical Trial

Acronym: NSFCT

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 25, 2013
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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