Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT04127929 - Investigation of Glass Carbomer Performance N/A
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Active, not recruiting NCT04475679 - Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy N/A
Completed NCT05438381 - Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars N/A
Not yet recruiting NCT03037814 - Clinical Performance of Restorative Materials in Primary Teeth N/A
Active, not recruiting NCT05202665 - Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion N/A
Terminated NCT01147835 - Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers N/A
Not yet recruiting NCT04033263 - Maintaining Oral Health With Bio-products N/A
Enrolling by invitation NCT04438252 - Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions N/A
Not yet recruiting NCT03609034 - Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT02473107 - Impact of Detecting Initial and Active Caries Lesions in Primary Teeth N/A
Active, not recruiting NCT02537184 - Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children N/A
Recruiting NCT02734420 - Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial Phase 1
Completed NCT02020681 - Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions N/A
Completed NCT02426619 - Arresting Active Dental Caries in Preschool Children by Topical Fluorides Phase 2/Phase 3
Completed NCT02234609 - Effectiveness of Modified Class IV Atraumatic Restorative Treatment N/A
Completed NCT01268605 - Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial Phase 3
Completed NCT01623362 - Evaluation of a Low Fluoride Dentifrice for Caries Control Phase 3