Clinical trial NCT02004990: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Keywords: Children, Plaque
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Dental Plaque Levels Measures on Scale of 0-2
timeFrame: 2-4 weeks
Secondary outcomes:
measure: Dental Plaque Composition Measured by Numbers of Bacteria Present
timeFrame: 2-4 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Pediatric Dental Clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Robert Jones, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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.