Dental Plaque
Conditions
Keywords
Children, Plaque
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.
Interventions
PROCEDURESingle cleansing procedure of 10% Povidone Iodine
Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Cleansing Procedure of 10% Povidone Iodine Cleansing 10% povidone iodine cleansing
Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Single Cleansing Procedure of 10% Povidone Iodine Cleansing |
|---|---|
| Age, Categorical <=18 years | 12 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Dental Plaque Levels Measures on Scale of 0-2
Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)
Time frame: 2-4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Cleansing Procedure of 10% Povidone Iodine Cleansing | Dental Plaque Levels Measures on Scale of 0-2 | 0.391 units on a scale | Standard Deviation 0.126 |
Secondary
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
Time frame: 2-4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Cleansing Procedure of 10% Povidone Iodine Cleansing | Dental Plaque Composition Measured by Numbers of Bacteria Present | 1.25 micrometers | Standard Deviation 0.04 |