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| Name | Class |
|---|---|
| Mott Children's Health Center | OTHER |
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The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF) for treatment of cavities in baby teeth. The investigators will compare the effectiveness of stopping the cavity, cost of the treatments and the opinions of the families and the dental providers.
To determine the effectiveness of the application of silver diamine fluoride (SDF) in comparison to conventional restorative treatments in International Caries Detection and Assessment System criteria (ICDAS) 5 and 6, one and two surface carious lesions in primary molars which will be assessed based on major and minor failure criteria when followed for one year. Additionally, parents'/children's and providers' perceptions will be assessed as well as the cost of both regimens, to include both chair time spent and materials' costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver Diamine Fluoride | Experimental | This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries. |
|
| Conventional Caries Management | Active Comparator | Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Diamine Fluoride | Device | No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet. |
| Measure | Description | Time Frame |
|---|---|---|
| Caries Arrest of Teeth in the SDF Group Measured by Change in Size | Number of participants in the SDF arm that had an increase in lesion size at any point in the 12 months of the trial, as this is a treatment failure. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were then removed from the trial for further clinical treatment. | 12 Months |
| Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black) | Color of the cavity at the end of the trial | 12 Months |
| Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard) | Texture of the cavity's dentin of soft means the cavity is still an active infection. If the cavity is hard, the cavity is no longer an active infection (has been arrested). Please note dentin texture cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment. | 12 Months |
| Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair) | Secondary caries, lost restorations, or restorations needing repair are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment. | 12 Months |
| Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess) | Signs of pulpal pathology are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less) | Data collected at baseline only. | Baseline |
| Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margherita R Fontana, DDS, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48109 | United States | ||
| Mott Children's Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35120408 | Derived | Cleary J, Al-Hadidi R, Scully A, Yahn W, Zaid Z, Boynton JR, Eckert GJ, Yanca E, Fontana M. A 12-Month Randomized Clinical Trial of 38% SDF vs. Restorative Treatment. JDR Clin Trans Res. 2022 Apr;7(2):135-144. doi: 10.1177/23800844211072741. Epub 2022 Feb 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Silver Diamine Fluoride | This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries. This is applied at baseline and at 6 Months. Silver Diamine Fluoride: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet. |
| FG001 | Conventional Caries Management | Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration. Conventional Caries Management: These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic and University of Michigan Pediatric Dental Clinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treatment failures were assessed throughout the 12 month duration of the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Silver Diamine Fluoride | This arm will receive Silver Diamine Fluoride applied to their carious lesion, at baseline and 6 months, in lieu of restoration placement, with the goal of arresting caries. Silver Diamine Fluoride: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride 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 | Caries Arrest of Teeth in the SDF Group Measured by Change in Size | Number of participants in the SDF arm that had an increase in lesion size at any point in the 12 months of the trial, as this is a treatment failure. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were then removed from the trial for further clinical treatment. | Posted | Count of Participants | Participants | 12 Months |
|
1 year
Patients were assessed clinically at baseline, 3, 6 and 12 months, and contacted at 1, 2, 4.5 and 9.5 months.
Some categories below have 0 patients at risk of the AE due to the AE only pertaining to one of the treatment arms. The SDF group did not have a restoration, so it could not have a missing restoration or secondary caries on that restoration. The Conventional group's lesion was no longer accessible as it was covered with a restoration, and so the the lesion texture could not be assessed.
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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 | This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries. This is applied at baseline and at 6 Months. Silver Diamine Fluoride: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride 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 |
|---|---|---|---|---|---|
| Radiographic signs of periapical infection | Infections and infestations | Systematic Assessment | Assessed at 12 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Yanca Project and Data Manager | University of Michigan School of Dentistry | 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 | Apr 27, 2016 | Aug 25, 2021 | Prot_SAP_000.pdf |
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|
| Conventional Caries Management | Procedure | These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration. |
|
|
| 12 Months |
| Baseline |
| Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable) | Baseline |
| Parent Assessment of Appearance of Child's Teeth | Parents were asked "Are you concerned with the appearance of your child's teeth?" | 12 Months |
| Parent Assessment of Treatment Provided | Parents were asked "If your child had another cavity, would you be willing to have that tooth treated with the same treatment option provided to your child in this study?" | 12 Months |
| Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad) | 12 Months |
| Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot) | 12 Months |
| Costs of Treatment (Dollars) | Cost of one application of SDF and one 1-2 surface conventional restoration. Cost was calculated by taking the average Medicaid reimbursement across all U.S. states. | Baseline |
| Time of Treatment Procedures (Duration of Time in Minutes) | Baseline |
| Flint |
| Michigan |
| 48503 |
| United States |
| BG001 | Conventional Caries Management | Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration. Conventional Caries Management: These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic and the University of Michigan School of Dentistry. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| dmft | A measure of the number of baby teeth impacted by dental decay in a child patient. A larger number means more decay. The range is 0 to 20. | Mean | Standard Deviation | dmft |
|
|
|
| Primary | Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black) | Color of the cavity at the end of the trial | Only 39 of the 40 children who attended the 12 month visit in the SDF arm had cavities available for assessment. One child's tooth exfoliated (fell out) normally one week prior to the 12 month appointment. Please note dentin color cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Primary | Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard) | Texture of the cavity's dentin of soft means the cavity is still an active infection. If the cavity is hard, the cavity is no longer an active infection (has been arrested). Please note dentin texture cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment. | Only 39 of the 40 children who attended the 12 month visit in the SDF arm had cavities available for assessment. One child's tooth exfoliated (fell out) normally one week prior to the 12 month appointment. Dentin texture cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Primary | Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair) | Secondary caries, lost restorations, or restorations needing repair are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment. | Please note restoration integrity cannot be assessed for the SDF group as this group does not receive a restoration. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Primary | Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess) | Signs of pulpal pathology are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment. | All children were assessed for signs of pulpal pathology throughout the trial. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less) | Data collected at baseline only. | The 98 instances of treatment below were given by about 15 providers. The provider stated how much time each treatment instance took compared to the alternate arm. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty) | The 98 instances of treatment below were given by about 15 providers. The provider stated the ease of treatment for each treatment instance. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable) | The 98 instances of treatment below were given by about 15 providers. The provider stated their treatment preference for each treatment instance. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Parent Assessment of Appearance of Child's Teeth | Parents were asked "Are you concerned with the appearance of your child's teeth?" | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | Parent Assessment of Treatment Provided | Parents were asked "If your child had another cavity, would you be willing to have that tooth treated with the same treatment option provided to your child in this study?" | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad) | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot) | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | Costs of Treatment (Dollars) | Cost of one application of SDF and one 1-2 surface conventional restoration. Cost was calculated by taking the average Medicaid reimbursement across all U.S. states. | Posted | Mean | Full Range | Dollars | Baseline |
|
|
|
| Secondary | Time of Treatment Procedures (Duration of Time in Minutes) | Posted | Mean | Full Range | Time in Minutes | Baseline |
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 36 |
| 56 |
| EG001 | Conventional Caries Management | Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration. Conventional Caries Management: These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic and University of Michigan Pediatric Dental Clinic. | 0 | 42 | 0 | 42 | 3 | 42 |
|
| Extraction | Infections and infestations | Systematic Assessment | Assessed at 12 months. |
|
| Active (soft) Lesion | Infections and infestations | Systematic Assessment |
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| Active (soft) Lesion with Progression | Infections and infestations | Systematic Assessment |
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| Hard (arrested) Lesion with Progression | Infections and infestations | Systematic Assessment |
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| Missing Restoration | Infections and infestations | Systematic Assessment |
|
| Secondary caries and lesion progression | Infections and infestations | Systematic Assessment |
|
| Reversible Pulpitis | Infections and infestations | Systematic Assessment |
|
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| Periapical Infection |
|
| No Sign of Pulpal Pathology |
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| Less time |
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| Harder for the provider |
|
| Less preferable treatment for provider |
|
| Very Sad |
|
| Hurt a Lot |
|