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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01950546
Other study ID # FOP01
Secondary ID
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


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
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