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| ID | Type | Description | Link |
|---|---|---|---|
| 8UL1TR000114-02 | U.S. NIH Grant/Contract | View source |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single cleansing procedure of 10% povidone iodine cleansing | Experimental | 10% povidone iodine cleansing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dental Plaque Levels Measures on Scale of 0-2 | Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse) | 2-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2-4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Jones, DDS | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Pediatric Dental Clinic | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26662044 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | units on a scale | 2-4 weeks |
|
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert S. Jones DDS PhD | University of Minnesota | 612-626-2900 | rsjones@umn.edu |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 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 | Posted | Mean | Standard Deviation | micrometers | 2-4 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |