Clinical Trials Directory

Trials / Completed

CompletedNCT02004990

Dental Office Prevention Strategies for Children

Dental Office Prevention Strategies for Children: 10% Povidone Iodine (PI) Cleansing Prior to Fluoride Varnish (FV) Application

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
University of Minnesota · Academic / Other
Sex
All
Age
6 Years – 13 Years
Healthy volunteers
Accepted

Summary

The overall goal of this study is to improve the standard of care in treating young children who often suffer from chronic caries (dental decay). Current standard of care for children under 12 years old includes a dental cleaning and fluoride treatment. Often this dental cleaning includes a 'dental prophylaxis' with a pumice based paste delivered by a small rubber-like cup that rotates on a slow-speed dental handpiece. The procedure of this dental prophylaxis removes the gross levels of plaque around the supragingival tooth surfaces. After this prophylaxis, a fluoride treatment is delivered. The National Maternal and Child Oral Health Resource Center at Georgetown University has published (Bertness J, Holt K) an extensive publication proving that 5% sodium fluoride varnish has become the 'standard of care' for fluoride treatment in children. This study includes this fluoride standard of care. Prior to the administration of this standard of care fluoride treatment, a separate step of cleansing the tooth after the dental prophylaxis is added. This study uses a cleansing procedure of 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application. The primary aims of this study are: 1. to measure the changes in overall plaque levels after using a 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application. 2. to measure the short term changes in the oral microbial ecology of dental plaque after 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.

Conditions

Interventions

TypeNameDescription
PROCEDURESingle cleansing procedure of 10% Povidone IodineSingle cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application

Timeline

Start date
2014-01-01
Primary completion
2015-09-01
Completion
2015-11-01
First posted
2013-12-09
Last updated
2017-03-10
Results posted
2016-12-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02004990. Inclusion in this directory is not an endorsement.