Nanosilver Fluoride to Prevent Dental Biofilms Growth

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nanosilver Fluoride: a Microbiological and Clinical Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: nanosilver fluoride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nanosilver fluoride<br>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<br>* 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.<br>* Other names: silver nanoparticles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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silver nanoparticles, antimicrobial activity, toxicity, biofilm, cariostatic agents