Nanosilver Fluoride to Prevent Dental Biofilms Growth (NSFCT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by University of Pernambuco
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Priscila Lima de Luna Freire, University of Pernambuco
ClinicalTrials.gov Identifier:
NCT01950546
First received: September 16, 2013
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Dental Caries
Drug: nanosilver fluoride
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Nanosilver Fluoride: a Microbiological and Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Pernambuco:

Primary Outcome Measures:
  • Initial biofilm collecting before applying the product and after nanosilver fluoride application. [ Time Frame: one week ] [ Designated as safety issue: Yes ]
    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:
  • Evaluation of effectiveness of nanosilver fluoride on bacterial growth in the dental biofilm [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
    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:
  • Collection of dental biofilm will after four weeks of product application. [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
    Collection of dental biofilm will be performed after four weeks of product application and colony count will be performed in the laboratory.

  • Collection of dental biofilm after eight weeks of product application [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: September 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 6 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950546

Contacts
Contact: PRISCILA L FREIRE, MSc +55 83 32446101 perezila@hotmail.com

Locations
Brazil
Escola Municipal Anita Trigueiro do Valle Not yet recruiting
João Pessoa, Paraíba, Brazil, 58046020
Contact: Priscila LL FREIRE    558332446101    perezila@hotmail.com   
Principal Investigator: Priscila LL Freire, MSc         
Sponsors and Collaborators
University of Pernambuco
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Study Director: Aronita Rosenblatt, PhD UPE
  More Information

No publications provided

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
Study First Received: September 16, 2013
Last Updated: August 18, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Pernambuco:
silver nanoparticles
antimicrobial activity
toxicity
biofilm
cariostatic agents

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

ClinicalTrials.gov processed this record on October 23, 2014