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Nanosilver Fluoride to Prevent Dental Biofilms Growth

Nanosilver Fluoride: a Microbiological and Clinical Trial

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01950546
Acronym
NSFCT
Enrollment
30
Registered
2013-09-25
Start date
2014-09-30
Completion date
2015-01-31
Last updated
2015-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

silver nanoparticles, antimicrobial activity, toxicity, biofilm, cariostatic agents

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.

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.

Interventions

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.

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
University of Pernambuco
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 6 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Initial biofilm collecting before applying the product and after nanosilver fluoride application.one weekThe 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

MeasureTime frameDescription
Evaluation of effectiveness of nanosilver fluoride on bacterial growth in the dental biofilmtwo weeksCollection of dental biofilm will be performed after two weeks of product application and colony count will be performed in the laboratory.

Other

MeasureTime frameDescription
Collection of dental biofilm will after four weeks of product application.Four weeksCollection 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 applicationEight weeksCollection 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026