A Phase 3 interventional study of Silver Diamine Fluoride and Conventional Caries Management in Caries, sponsored by University of Michigan. Completed at 2 sites in United States. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by University of Michigan · Phase 3, Interventional, and Treatment
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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Exclusion Criteria:
This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries.
Device: Silver Diamine Fluoride
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.
Procedure: Conventional Caries Management
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.
Also known as: Silver Dental Arrest
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.
Also known as: Filling, Restoration
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 Months
Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)
Data collected at baseline only.
Time frame: Baseline
Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)
Time frame: Baseline
Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)
Time frame: Baseline
Parent Assessment of Appearance of Child's Teeth
Parents were asked "Are you concerned with the appearance of your child's teeth?"
Time frame: 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?"
Time frame: 12 Months
Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)
Time frame: 12 Months
Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)
Time frame: 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.
Time frame: Baseline
Time of Treatment Procedures (Duration of Time in Minutes)
Time frame: Baseline
| Milestone | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| Started | 56 | 42 |
| Completed | 40 | 29 |
| Not completed | 16 | 13 |
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.
| Participants | Silver Diamine Fluoride |
|---|---|
| Caries Arrest of Teeth in the SDF Group Measured by Change in Size | 10 |
Color of the cavity at the end of the trial
| Participants | Silver Diamine Fluoride |
|---|---|
| Black | 37 |
| Brown | 0 |
| Yellow | 2 |
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.
| Participants | Silver Diamine Fluoride |
|---|---|
| Soft Dentin | 10 |
| Hard Dentin | 29 |
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.
| Participants | Conventional Caries Management |
|---|---|
| Missing restoration | 1 |
| Secondary caries and lesion progression | 1 |
| Intact restoration | 40 |
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.
| Participants | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| Reversible Pulpitis | 1 | 1 |
| Reversible Pulpitis and Later Periapical Infection | 2 | 0 |
| Periapical Infection | 2 | 0 |
| No Sign of Pulpal Pathology | 51 | 41 |
Data collected at baseline only.
| Participants | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| More time | 0 | 12 |
| Same amount of time | 1 | 27 |
| Less time | 55 | 3 |
| Participants | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| Easier for the provider | 46 | 2 |
| The same level of difficulty for provider | 10 | 31 |
| Harder for the provider | 0 | 9 |
| Participants | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| More preferable treatment for provider | 21 | 0 |
| No preference in treatment for provider | 35 | 41 |
| Less preferable treatment for provider | 0 | 1 |
Parents were asked "Are you concerned with the appearance of your child's teeth?"
| Participants | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| No | 33 | 26 |
| Yes | 7 | 3 |
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?"
| Participants | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| No | 7 | 3 |
| Yes | 33 | 26 |
| Participants | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| Very Happy | 29 | 26 |
| Not Happy or Sad | 7 | 3 |
| Very Sad | 4 | 0 |
| Participants | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| Didn't Hurt at All | 27 | 25 |
| Hurt a Little | 10 | 4 |
| Hurt a Lot | 3 | 0 |
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.
| Dollars | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| Costs of Treatment (Dollars) | 20.62 (2.71 to 98.50) | 79.68 (30.00 to 178.80) |
| Time in Minutes | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| Time of Treatment Procedures (Duration of Time in Minutes) | 5 (5 to 10) | 30 (17 to 40) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Silver Diamine Fluoride | 0/56 (0%) | 0/56 (0%) | 36/56 (64.3%) |
| Conventional Caries Management | 0/42 (0%) | 0/42 (0%) | 3/42 (7.1%) |
| Event | Silver Diamine Fluoride | Conventional Caries Management |
|---|---|---|
| Active (soft) LesionInfections and infestations | 25/56 | — |
| Active (soft) Lesion with ProgressionInfections and infestations | 7/56 | — |
| Radiographic signs of periapical infectionInfections and infestations | 4/56 | 0/42 |
| ExtractionInfections and infestations | 3/56 | 0/42 |
| Hard (arrested) Lesion with ProgressionInfections and infestations | 3/56 | — |
| Reversible PulpitisInfections and infestations | 3/56 | 1/42 |
| Missing RestorationInfections and infestations | — | 1/42 |
| Secondary caries and lesion progressionInfections and infestations | — | 1/42 |
Treatment failures were assessed throughout the 12 month duration of the trial.
| Age, Categorical(Participants) | Silver Diamine Fluoride | Conventional Caries Management | Total |
|---|---|---|---|
| <=18 years | 56 | 42 | 98 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Silver Diamine Fluoride | Conventional Caries Management | Total |
|---|---|---|---|
| Mean | 4.7 ± 1.9 | 4.8 ± 1.7 | 4.8 ± 1.8 |
| Sex: Female, Male(Participants) | Silver Diamine Fluoride | Conventional Caries Management | Total |
|---|---|---|---|
| Female | 29 | 16 | 45 |
| Male | 27 | 26 | 53 |
| Ethnicity (NIH/OMB)(Participants) | Silver Diamine Fluoride | Conventional Caries Management | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 2 | 7 |
| Not Hispanic or Latino | 51 | 40 | 91 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Silver Diamine Fluoride | Conventional Caries Management | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 32 | 22 | 54 |
| White | 14 | 16 | 30 |
| More than one race | 6 | 4 | 10 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Region of Enrollment(participants) | Silver Diamine Fluoride | Conventional Caries Management | Total |
|---|---|---|---|
| United States | 56 | 42 | 98 |
| dmft(dmft) | Silver Diamine Fluoride | Conventional Caries Management | Total |
|---|---|---|---|
| Mean | 5.6 ± 3.7 | 7.2 ± 3.8 | 6.3 ± 3.9 |
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