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| Name | Class |
|---|---|
| The Forsyth Institute | OTHER |
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The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment.
To assess the effect of silver diamine fluoride (SDF) treatment on microorganisms present in root caries or cervical lesions by collecting microbial deposits before and 1 month after SDF application. Bacterial samples will be collected from 20 adult subjects at the initial visit before application of SDF and one month after. At the 1 month recall, examination for caries arrest will be performed. All 40 bacterial samples will be sent to the Forsyth Institute to verify bacterial composition using HOMINGS technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver Diamine Fluoride (SDF) | Experimental | Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Diamine Fluoride (SDF) | Device | No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions | Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application. | baseline, One month after SDF |
| Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard) | Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below. | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled) | Each subject was asked if they were concerned with the appearance of the tooth that SDF was applied too. They were also asked if they wanted the study tooth to be filled with a tooth color filling. | One month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heba Mitwalli, DDS | University of Michigan | Principal Investigator |
| Margherita Fontana, DDS, PhD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Silver Diamine Fluoride (SDF) | Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application. Silver Diamine Fluoride (SDF): No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Silver Diamine Fluoride (SDF) | Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application. Silver Diamine Fluoride (SDF): No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet |
| 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 | Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions | Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application. | Posted | Number | bacterial count | baseline, One month after SDF |
|
7 months
Number of Participants at Risk is equal to the number of participants enrolled
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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 | Silver Diamine Fluoride (SDF) | Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application. Silver Diamine Fluoride (SDF): No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unfavorable taste | General disorders | Non-systematic Assessment | When applying the SDF |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Yanca | University of Michigan | 734-763-3988 | emthorpe@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2016 | Apr 2, 2018 | Prot_SAP_000.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard) | Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below. | Posted | Number | cervical lesions | One month |
|
|
|
| Secondary | Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled) | Each subject was asked if they were concerned with the appearance of the tooth that SDF was applied too. They were also asked if they wanted the study tooth to be filled with a tooth color filling. | Posted | Count of Participants | Participants | One month |
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| 0 |
| 21 |
| 0 |
| 21 |
| 21 |
| 21 |
| Burning sensation | General disorders | Non-systematic Assessment | When applying the SDF |
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| Black stain | General disorders | Non-systematic Assessment | Subjects had black stain in the cavity |
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