Dental Office Prevention Strategies for Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02004990|
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : December 21, 2016
Last Update Posted : March 10, 2017
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.
|Condition or disease||Intervention/treatment|
|Dental Plaque||Procedure: Single cleansing procedure of 10% Povidone Iodine|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||January 2014|
|Primary Completion Date :||September 2015|
|Study Completion Date :||November 2015|
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
- Dental Plaque Levels Measures on Scale of 0-2 [ Time Frame: 2-4 weeks ]Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)
- Dental Plaque Composition Measured by Numbers of Bacteria Present [ Time Frame: 2-4 weeks ]Dental plaque is a multispecies bacterial biofilm and the specific bacteria populating this biofilm will be measured. Measurement will be change in thickness of the biofilm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004990
|United States, Minnesota|
|University of Minnesota Pediatric Dental Clinic|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Robert Jones, DDS||University of Minnesota - Clinical and Translational Science Institute|