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Nanosilver Fluoride to Prevent Dental Biofilms Growth (NSFCT)

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
nanosilver fluoride
Sponsored by
University of Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring silver nanoparticles, antimicrobial activity, toxicity, biofilm, cariostatic agents

Eligibility Criteria

5 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Escola Municipal Anita Trigueiro do Valle

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nanosilver fluoride

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2013
Last Updated
June 8, 2015
Sponsor
University of Pernambuco
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT01950546
Brief Title
Nanosilver Fluoride to Prevent Dental Biofilms Growth
Acronym
NSFCT
Official Title
Nanosilver Fluoride: a Microbiological and Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pernambuco
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
silver nanoparticles, antimicrobial activity, toxicity, biofilm, cariostatic agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nanosilver fluoride
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
nanosilver fluoride
Other Intervention Name(s)
silver nanoparticles
Intervention Description
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.
Primary Outcome Measure Information:
Title
Initial biofilm collecting before applying the product and after nanosilver fluoride application.
Description
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Evaluation of effectiveness of nanosilver fluoride on bacterial growth in the dental biofilm
Description
Collection of dental biofilm will be performed after two weeks of product application and colony count will be performed in the laboratory.
Time Frame
two weeks
Other Pre-specified Outcome Measures:
Title
Collection of dental biofilm will after four weeks of product application.
Description
Collection of dental biofilm will be performed after four weeks of product application and colony count will be performed in the laboratory.
Time Frame
Four weeks
Title
Collection of dental biofilm after eight weeks of product application
Description
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.
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aronita Rosenblatt, PhD
Organizational Affiliation
UPE
Official's Role
Study Director
Facility Information:
Facility Name
Escola Municipal Anita Trigueiro do Valle
City
João Pessoa
State/Province
Paraíba
ZIP/Postal Code
58046020
Country
Brazil

12. IPD Sharing Statement

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Nanosilver Fluoride to Prevent Dental Biofilms Growth

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