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Dental Office Prevention Strategies for Children

NCT02004990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-03-10

Study results available
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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

  • Dental Plaque

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Robert Jones, DDS · University of Minnesota

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-09-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02004990 on ClinicalTrials.gov