Nanosilver Fluoride to Prevent Dental Biofilms Growth

Phase 1

Completed

• Conditions: Dental Caries
• Interventions: Drug: nanosilver fluoride

• Registration Number: NCT01950546
• Lead Sponsor: University of Pernambuco

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.

Study Timeline

• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-21
• Study First Posted: 2013-09-25
• Study Start: 2014-09
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nanosilver fluoride	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.

Primary Outcome Measures

Name	Time	Method
Initial biofilm collecting before applying the product and after nanosilver fluoride application.	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

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

Trial Locations

Locations (1)

Escola Municipal Anita Trigueiro do Valle; 🇧🇷 João Pessoa, Paraíba, Brazil