Nanosilver Fluoride to Prevent Dental Biofilms Growth

NCT01950546 | Completed Phase 1 DMC

• 1 other identifier: FOP01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  one week

Secondary Outcomes (1)

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

  two weeks

Other Outcomes (2)

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

  Four weeks

• Collection of dental biofilm after eight weeks of product application

  Eight weeks

Study Arms (1)

Nanosilver fluoride

EXPERIMENTAL

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

Interventions

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.

Also known as: silver nanoparticles

Nanosilver fluoride

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• Presenting oral lesions, supragingival calculus and severe malocclusion.

Sponsors & Collaborators

• University of Pernambuco: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Escola Municipal Anita Trigueiro do Valle

João Pessoa, Paraíba, 58046020, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Interventions

colloidal silver

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Aronita Rosenblatt, PhD

  UPE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc, School of Dentistry, University of Pernambuco,

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 25, 2013
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

BR (1)