Dental Office Prevention Strategies for Children
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:
- to measure the changes in overall plaque levels after using a 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.
- 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Dental Office Prevention Strategies for Children: 10% Povidone Iodine (PI) Cleansing Prior to Fluoride Varnish (FV) Application|
- dental plaque levels [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]Modified plaque index for the mixed dentition
- dental plaque composition [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]Dental plaque is a multispecies bacterial biofilm and the specific bacteria populating this biofilm will be measured.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Single cleansing procedure of 10% povidone iodine cleansing
10% povidone iodine cleansing
Procedure: Single cleansing procedure of 10% Povidone Iodine
Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application
Please refer to this study by its ClinicalTrials.gov identifier: NCT02004990
|Contact: Robert Jones, DDS PhDemail@example.com|
|United States, Minnesota|
|University of Minnesota Pediatric Dental Clinic||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Robert Jones 612-659-4900 firstname.lastname@example.org|
|Principal Investigator: Robert Jones, DDS PhD|
|Sub-Investigator: Mike Steinmetz, DDS|
|Sub-Investigator: Madeline Goettl, DDS|
|Principal Investigator:||Robert Jones, DDS||University of Minnesota - Clinical and Translational Science Institute|