Nanosilver Fluoride to Prevent Dental Biofilms Growth

Dental Caries Clinical Trial

— NSFCT  

Official title:

Nanosilver Fluoride: a Microbiological and Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950546
• Other study ID #: FOP01
• Status: Completed
• Phase: Phase 1
• First received: September 16, 2013
• Last updated: June 8, 2015
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: University of Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effectiveness of nanosilver fluoride for controlling the growth of S. mutans present in dental plaque of children.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 6 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
Brazil	Escola Municipal Anita Trigueiro do Valle	João Pessoa	Paraíba

Sponsors (2)

Lead Sponsor	Collaborator
University of Pernambuco	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Collection of dental biofilm will after four weeks of product application.	Collection of dental biofilm will be performed after four weeks of product application and colony count will be performed in the laboratory.	Four weeks	Yes
Other	Collection of dental biofilm after eight weeks of product application	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.	Eight weeks	Yes
Primary	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	Yes
Secondary	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	Yes