Nanosilver Fluoride to Prevent Dental Biofilms Growth (NSFCT)
This study aims to evaluate the effectiveness of nanosilver fluoride for controlling the growth of S. mutans present in dental plaque of children.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Nanosilver Fluoride: a Microbiological and Clinical Trial|
- Initial biofilm collecting before applying the product and after nanosilver fluoride application. [ Time Frame: one week ] [ Designated as safety issue: Yes ]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.
- Evaluation of effectiveness of nanosilver fluoride on bacterial growth in the dental biofilm [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]Collection of dental biofilm will be performed after two weeks of product application and colony count will be performed in the laboratory.
- Collection of dental biofilm will after four weeks of product application. [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]Collection 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 application [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||September 2014|
|Study Completion Date:||January 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: nanosilver fluoride
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.
Other Name: silver nanoparticles
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01950546
|Escola Municipal Anita Trigueiro do Valle|
|João Pessoa, Paraíba, Brazil, 58046020|
|Study Director:||Aronita Rosenblatt, PhD||UPE|