Dental Office Prevention Strategies for Children

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Procedure: Single cleansing procedure of 10% Povidone Iodine

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Pediatric Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria: Ages 6-12 years age. Recent history (< 24 months) of childhood caries, weight ≥ 15 kg, and current dental radiographic films within standard of care practices. At this time, we are looking for longitudinal changes within this cohort and are not using condition-matched controls.

Exclusion Criteria:

• Exclusion criteria: Weight <15 kg; Iodine or seafood allergy; hypersensitivity to fluoride varnish; antibiotics within the past 3 months; thyroid disease; significant past or current medical problem history, especially conditions that may affect salivary flow, dietary intake patterns, or routine oral hygiene.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Plaque Levels Measures on Scale of 0-2	Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)	2-4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Plaque Composition Measured by Numbers of Bacteria Present	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	2-4 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Robert Jones, DDS, University of Minnesota

Publications and helpful links

General Publications

• Reilly C, Goettl M, Steinmetz M, Nikrad J, Jones RS. Short-term effects of povidone iodine and sodium fluoride therapy on plaque levels and microbiome diversity. Oral Dis. 2016 Mar;22(2):155-61. doi: 10.1111/odi.12407. Epub 2016 Jan 14.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: December 3, 2013
• First Posted (ESTIMATE): December 9, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Children, Plaque
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: 1310M44463; 8UL1TR000114-02 (NIH)