Dental Office Prevention Strategies for Children
Primary Purpose
Dental Plaque
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single cleansing procedure of 10% Povidone Iodine
Sponsored by
About this trial
This is an interventional basic science trial for Dental Plaque focused on measuring Children, Plaque
Eligibility Criteria
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.
Sites / Locations
- University of Minnesota Pediatric Dental Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single cleansing procedure of 10% povidone iodine cleansing
Arm Description
10% povidone iodine cleansing
Outcomes
Primary Outcome Measures
Dental Plaque Levels Measures on Scale of 0-2
Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02004990
First Posted
November 18, 2013
Last Updated
January 27, 2017
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT02004990
Brief Title
Dental Office Prevention Strategies for Children
Official Title
Dental Office Prevention Strategies for Children: 10% Povidone Iodine (PI) Cleansing Prior to Fluoride Varnish (FV) Application
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Children, Plaque
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single cleansing procedure of 10% povidone iodine cleansing
Arm Type
Experimental
Arm Description
10% povidone iodine cleansing
Intervention Type
Procedure
Intervention Name(s)
Single cleansing procedure of 10% Povidone Iodine
Intervention Description
Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application
Primary Outcome Measure Information:
Title
Dental Plaque Levels Measures on Scale of 0-2
Description
Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)
Time Frame
2-4 weeks
Secondary Outcome Measure Information:
Title
Dental Plaque Composition Measured by Numbers of Bacteria Present
Description
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
Time Frame
2-4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jones, DDS
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Pediatric Dental Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26662044
Citation
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.
Results Reference
result
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Dental Office Prevention Strategies for Children
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