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Nanosilver Fluoride to Prevent Dental Biofilms Growth (NSFCT)

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ClinicalTrials.gov Identifier: NCT01950546
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : June 10, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Dental Caries Drug: nanosilver fluoride Phase 1

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Nanosilver Fluoride: a Microbiological and Clinical Trial
Study Start Date : September 2014
Primary Completion Date : December 2014
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: silver nanoparticles


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950546


Locations
Brazil
Escola Municipal Anita Trigueiro do Valle
João Pessoa, Paraíba, Brazil, 58046020
Sponsors and Collaborators
University of Pernambuco
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Study Director: Aronita Rosenblatt, PhD UPE
More Information

Responsible Party: Priscila Lima de Luna Freire, Msc, School of Dentistry, University of Pernambuco,, University of Pernambuco
ClinicalTrials.gov Identifier: NCT01950546     History of Changes
Other Study ID Numbers: FOP01
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by Priscila Lima de Luna Freire, University of Pernambuco:
silver nanoparticles
antimicrobial activity
toxicity
biofilm
cariostatic agents

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs