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OpenTrials
Completed

NCT Number: NCT02004990

Dental Office Prevention Strategies for Children

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.

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Key information

Conditions

Dental Plaque Dental Deposits Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Stomatognathic Diseases Tooth Diseases

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Pediatric Dental Clinic

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single cleansing procedure of 10% Povidone Iodine

Procedure

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

Primary outcomes

  1. Dental Plaque Levels Measures on Scale of 0-2

    Time frame: 2-4 weeks

    Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)

Secondary outcomes

  1. Dental Plaque Composition Measured by Numbers of Bacteria Present

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2013
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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