Dental Office Prevention Strategies for Children

Not Applicable

Completed

• Conditions: Dental Plaque
• Interventions: Procedure: Single cleansing procedure of 10% Povidone Iodine

• Registration Number: NCT02004990
• Lead Sponsor: University of Minnesota

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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Study Start: 2014-01
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Results First Submitted: 2016-05-17
• Results First Submitted QC: 2016-10-28
• Results First Posted: 2016-12-21
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single cleansing procedure of 10% povidone iodine cleansing	Single cleansing procedure of 10% Povidone Iodine	10% povidone iodine cleansing

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Dental Plaque Composition Measured by Numbers of Bacteria Present	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

Trial Locations

Locations (1)

University of Minnesota Pediatric Dental Clinic; 🇺🇸 Minneapolis, Minnesota, United States