Trial Outcomes & Findings for Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques (NCT NCT02601833)
NCT ID: NCT02601833
Last Updated: 2021-11-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
98 participants
Primary outcome timeframe
12 Months
Results posted on
2021-11-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
42
|
|
Overall Study
COMPLETED
|
40
|
29
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques
Baseline characteristics by cohort
| Measure |
Silver Diamine Fluoride
n=56 Participants
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.
|
Conventional Caries Management
n=42 Participants
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.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
56 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.7 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
4.8 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
4.8 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
42 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
dmft
|
5.6 dmft
STANDARD_DEVIATION 3.7 • n=5 Participants
|
7.2 dmft
STANDARD_DEVIATION 3.8 • n=7 Participants
|
6.3 dmft
STANDARD_DEVIATION 3.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsNumber 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.
Outcome measures
| Measure |
Silver Diamine Fluoride
n=56 Participants
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.
|
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.
|
|---|---|---|
|
Caries Arrest of Teeth in the SDF Group Measured by Change in Size
|
10 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: 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.
Color of the cavity at the end of the trial
Outcome measures
| Measure |
Silver Diamine Fluoride
n=39 Participants
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.
|
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.
|
|---|---|---|
|
Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)
Black
|
37 Participants
|
—
|
|
Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)
Brown
|
0 Participants
|
—
|
|
Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)
Yellow
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Silver Diamine Fluoride
n=39 Participants
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.
|
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.
|
|---|---|---|
|
Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard)
Hard Dentin
|
29 Participants
|
—
|
|
Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard)
Soft Dentin
|
10 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Please note restoration integrity cannot be assessed for the SDF group as this group does not receive a restoration.
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.
Outcome measures
| Measure |
Silver Diamine Fluoride
n=42 Participants
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.
|
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.
|
|---|---|---|
|
Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)
Missing restoration
|
1 Participants
|
—
|
|
Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)
Secondary caries and lesion progression
|
1 Participants
|
—
|
|
Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)
Intact restoration
|
40 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: All children were assessed for signs of pulpal pathology throughout the trial.
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.
Outcome measures
| Measure |
Silver Diamine Fluoride
n=56 Participants
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.
|
Conventional Caries Management
n=42 Participants
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.
|
|---|---|---|
|
Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)
Reversible Pulpitis
|
1 Participants
|
1 Participants
|
|
Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)
Reversible Pulpitis and Later Periapical Infection
|
2 Participants
|
0 Participants
|
|
Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)
Periapical Infection
|
2 Participants
|
0 Participants
|
|
Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)
No Sign of Pulpal Pathology
|
51 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
Data collected at baseline only.
Outcome measures
| Measure |
Silver Diamine Fluoride
n=56 Participants
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.
|
Conventional Caries Management
n=42 Participants
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.
|
|---|---|---|
|
Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)
More time
|
0 Participants
|
12 Participants
|
|
Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)
Same amount of time
|
1 Participants
|
27 Participants
|
|
Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)
Less time
|
55 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: The 98 instances of treatment below were given by about 15 providers. The provider stated the ease of treatment for each treatment instance.
Outcome measures
| Measure |
Silver Diamine Fluoride
n=56 Participants
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.
|
Conventional Caries Management
n=42 Participants
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.
|
|---|---|---|
|
Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)
Easier for the provider
|
46 Participants
|
2 Participants
|
|
Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)
The same level of difficulty for provider
|
10 Participants
|
31 Participants
|
|
Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)
Harder for the provider
|
0 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: The 98 instances of treatment below were given by about 15 providers. The provider stated their treatment preference for each treatment instance.
Outcome measures
| Measure |
Silver Diamine Fluoride
n=56 Participants
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.
|
Conventional Caries Management
n=42 Participants
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.
|
|---|---|---|
|
Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)
More preferable treatment for provider
|
21 Participants
|
0 Participants
|
|
Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)
No preference in treatment for provider
|
35 Participants
|
41 Participants
|
|
Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)
Less preferable treatment for provider
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsParents were asked "Are you concerned with the appearance of your child's teeth?"
Outcome measures
| Measure |
Silver Diamine Fluoride
n=40 Participants
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.
|
Conventional Caries Management
n=29 Participants
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.
|
|---|---|---|
|
Parent Assessment of Appearance of Child's Teeth
No
|
33 Participants
|
26 Participants
|
|
Parent Assessment of Appearance of Child's Teeth
Yes
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsParents 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?"
Outcome measures
| Measure |
Silver Diamine Fluoride
n=40 Participants
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.
|
Conventional Caries Management
n=29 Participants
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.
|
|---|---|---|
|
Parent Assessment of Treatment Provided
Yes
|
33 Participants
|
26 Participants
|
|
Parent Assessment of Treatment Provided
No
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Silver Diamine Fluoride
n=40 Participants
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.
|
Conventional Caries Management
n=29 Participants
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.
|
|---|---|---|
|
Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)
Very Happy
|
29 Participants
|
26 Participants
|
|
Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)
Not Happy or Sad
|
7 Participants
|
3 Participants
|
|
Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)
Very Sad
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Silver Diamine Fluoride
n=40 Participants
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.
|
Conventional Caries Management
n=29 Participants
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.
|
|---|---|---|
|
Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)
Didn't Hurt at All
|
27 Participants
|
25 Participants
|
|
Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)
Hurt a Little
|
10 Participants
|
4 Participants
|
|
Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)
Hurt a Lot
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: BaselineCost 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.
Outcome measures
| Measure |
Silver Diamine Fluoride
n=56 Participants
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.
|
Conventional Caries Management
n=42 Participants
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.
|
|---|---|---|
|
Costs of Treatment (Dollars)
|
20.62 Dollars
Interval 2.71 to 98.5
|
79.68 Dollars
Interval 30.0 to 178.8
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Silver Diamine Fluoride
n=56 Participants
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.
|
Conventional Caries Management
n=42 Participants
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.
|
|---|---|---|
|
Time of Treatment Procedures (Duration of Time in Minutes)
|
5 Time in Minutes
Interval 5.0 to 10.0
|
30 Time in Minutes
Interval 17.0 to 40.0
|
Adverse Events
Silver Diamine Fluoride
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Conventional Caries Management
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Silver Diamine Fluoride
n=56 participants at risk
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.
|
Conventional Caries Management
n=42 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Radiographic signs of periapical infection
|
7.1%
4/56 • 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.
|
0.00%
0/42 • 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.
|
|
Infections and infestations
Extraction
|
5.4%
3/56 • 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.
|
0.00%
0/42 • 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.
|
|
Infections and infestations
Active (soft) Lesion
|
44.6%
25/56 • 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.
|
—
0/0 • 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.
|
|
Infections and infestations
Active (soft) Lesion with Progression
|
12.5%
7/56 • 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.
|
—
0/0 • 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.
|
|
Infections and infestations
Hard (arrested) Lesion with Progression
|
5.4%
3/56 • 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.
|
—
0/0 • 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.
|
|
Infections and infestations
Missing Restoration
|
—
0/0 • 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.
|
2.4%
1/42 • 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.
|
|
Infections and infestations
Secondary caries and lesion progression
|
—
0/0 • 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.
|
2.4%
1/42 • 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.
|
|
Infections and infestations
Reversible Pulpitis
|
5.4%
3/56 • 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.
|
2.4%
1/42 • 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.
|
Additional Information
Emily Yanca Project and Data Manager
University of Michigan School of Dentistry
Phone: 734-763-3988
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place