NCT02004990

Brief 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. 1.to measure the changes in overall plaque levels after using a 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 21, 2016

Completed
Last Updated

March 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

November 18, 2013

Results QC Date

May 17, 2016

Last Update Submit

January 27, 2017

Conditions

Dental Plaque

Keywords

Children, Plaque

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Dental Plaque Composition Measured by Numbers of Bacteria Present

    2-4 weeks

Study Arms (1)

Single cleansing procedure of 10% povidone iodine cleansing

EXPERIMENTAL

10% povidone iodine cleansing

Procedure: Single cleansing procedure of 10% Povidone Iodine

Interventions

Single cleansing procedure of 10% Povidone IodinePROCEDURE

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

Single cleansing procedure of 10% povidone iodine cleansing

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Pediatric Dental Clinic

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • 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.

    PMID: 26662044RESULT

MeSH Terms

Conditions

Dental PlaquePlaque, Amyloid

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Robert S. Jones DDS PhD
Organization
University of Minnesota
rsjones@umn.edu
612-626-2900

Study Officials

  • Robert Jones, DDS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2013

First Posted

December 9, 2013

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

March 10, 2017

Results First Posted

December 21, 2016

Record last verified: 2017-01

Locations

US(1)