Trial Outcomes & Findings for Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions (NCT NCT03649659)
NCT ID: NCT03649659
Last Updated: 2026-08-12
Results Overview
Arrested trial lesions will be assessed by determining if the lesion is hard or soft by pressing on the lesion using a standard probe as assessed by calibrated examiners.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
830 participants
Primary outcome timeframe
6 months
Results posted on
2026-08-12
Participant Flow
Participant milestones
| Measure |
Silver Diamine Fluoride (SDF)
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
|---|---|---|
|
Overall Study
STARTED
|
414
|
416
|
|
Overall Study
COMPLETED
|
278
|
265
|
|
Overall Study
NOT COMPLETED
|
136
|
151
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions
Baseline characteristics by cohort
| Measure |
Silver Diamine Fluoride (SDF)
n=414 Participants
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
n=416 Participants
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
Total
n=830 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Child Age 1 Years
|
15 Participants
n=1 Participants
|
19 Participants
n=1 Participants
|
34 Participants
n=1 Participants
|
|
Age, Customized
Child Age 2 Years
|
56 Participants
n=1 Participants
|
56 Participants
n=1 Participants
|
112 Participants
n=1 Participants
|
|
Age, Customized
Child Age 3 Years
|
124 Participants
n=1 Participants
|
107 Participants
n=1 Participants
|
231 Participants
n=1 Participants
|
|
Age, Customized
Child Age 4 Years
|
155 Participants
n=1 Participants
|
170 Participants
n=1 Participants
|
325 Participants
n=1 Participants
|
|
Age, Customized
Child Age 5 Years
|
64 Participants
n=1 Participants
|
64 Participants
n=1 Participants
|
128 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
228 Participants
n=1 Participants
|
200 Participants
n=1 Participants
|
428 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=1 Participants
|
216 Participants
n=1 Participants
|
402 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
182 Participants
n=1 Participants
|
183 Participants
n=1 Participants
|
365 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
228 Participants
n=1 Participants
|
219 Participants
n=1 Participants
|
447 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=1 Participants
|
14 Participants
n=1 Participants
|
18 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=1 Participants
|
24 Participants
n=1 Participants
|
50 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
85 Participants
n=1 Participants
|
86 Participants
n=1 Participants
|
171 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=1 Participants
|
132 Participants
n=1 Participants
|
270 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
24 Participants
n=1 Participants
|
37 Participants
n=1 Participants
|
61 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
138 Participants
n=1 Participants
|
134 Participants
n=1 Participants
|
272 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
414 participants
n=1 Participants
|
416 participants
n=1 Participants
|
830 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsArrested trial lesions will be assessed by determining if the lesion is hard or soft by pressing on the lesion using a standard probe as assessed by calibrated examiners.
Outcome measures
| Measure |
Silver Diamine Fluoride (SDF)
n=414 Participants
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
n=416 Participants
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
|---|---|---|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo
|
54 percentage of lesions arrested
Interval 43.1 to 64.4
|
22.5 percentage of lesions arrested
Interval 15.3 to 31.8
|
SECONDARY outcome
Timeframe: 8 monthsArrested trial lesions will be assessed by determining if the lesion is hard or soft after two SDF applications by pressing on the lesion using a standard probe as assessed by calibrated examiners.
Outcome measures
| Measure |
Silver Diamine Fluoride (SDF)
n=414 Participants
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
n=416 Participants
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
|---|---|---|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After Two Treatments With SDF or Placebo
|
50.2 percentage of lesions arrested
Interval 39.5 to 60.9
|
17.4 percentage of lesions arrested
Interval 11.4 to 25.7
|
SECONDARY outcome
Timeframe: 3 monthsProportion of arrested trial lesions will be assessed by determining if the lesion is hard or soft by pressing on the lesion using a standard probe as assessed by calibrated examiners. The effect of a single application will be assessed at 3-month follow-up post initial treatment.
Outcome measures
| Measure |
Silver Diamine Fluoride (SDF)
n=414 Participants
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
n=416 Participants
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
|---|---|---|
|
Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo
|
57.5 percentage of lesion arrest
Interval 46.5 to 67.8
|
18.8 percentage of lesion arrest
Interval 12.4 to 27.5
|
SECONDARY outcome
Timeframe: Baseline, 24-48 hour call, 1.5 month, 3 month, 4.5 month, 6 month, 24-48 hours after 6 month, 7 month, 8 monthThe presence of pain associated with a trial lesion was screened at baseline a score of 1 or higher using the Dental Discomfort Questionnaire (DDQ). The DDQ is a validated tool assessing pain in children 5 and younger, as reported by parents/legal guardians, based on observation of toothache pain-related behaviors by the child. It consists of two parts: a question of the occurrence of toothache and when (if no pain DDQ score of 0,best), and 8 validated questions about behaviors associated with toothache or discomfort due to caries on a three-point scale: 0 'never', 1 'sometimes', and 2 'often'. Total score is the sum of the 8 questions in part two, ranging from 0 (no pain) to 16 (worst score). A DDQ score of 1 or higher may not be caused by pain in a trial tooth, so children with a DDQ score of 1 or higher were examined during a clinical visit to determine if the trial teeth had pain. Pain associated with a trial tooth at any time after baseline treatment counted as trial lesion pain.
Outcome measures
| Measure |
Silver Diamine Fluoride (SDF)
n=414 Participants
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
n=416 Participants
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
|---|---|---|
|
Proportion of Trial Lesions With Pain Prior to or at the 8-month Visit
|
2.7 percentage of trial lesions with pain
Interval 0.8 to 8.9
|
2.8 percentage of trial lesions with pain
Interval 0.8 to 9.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Data were stratified by sex
NIH-required analysis. Arrested trial lesions will be assessed by determining if the lesion is hard or soft by pressing on the lesion using a standard probe as assessed by calibrated examiners.
Outcome measures
| Measure |
Silver Diamine Fluoride (SDF)
n=414 Participants
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
n=416 Participants
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
|---|---|---|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Sex
Female
|
54.3 percentage of lesions arrested
Interval 39.1 to 68.7
|
19.1 percentage of lesions arrested
Interval 10.4 to 32.4
|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Sex
Male
|
54.8 percentage of lesions arrested
Interval 39.5 to 69.2
|
25.8 percentage of lesions arrested
Interval 14.9 to 40.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Data were stratified by ethnicity. Due to the small number of participants in the subgroup Ethnicity Not Reported, the analysis model was unable to calculate estimates and confidence intervals. A simplified calculation ignoring the correlation among multiple lesions within a subject was used to obtain these estimates.
NIH-required analysis. Arrested trial lesions will be assessed by determining if the lesion is hard or soft by pressing on the lesion using a standard probe as assessed by calibrated examiners.
Outcome measures
| Measure |
Silver Diamine Fluoride (SDF)
n=414 Participants
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
n=416 Participants
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
|---|---|---|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Ethnicity
Hispanic/Latino
|
62.9 percentage of lesions arrested
Interval 50.5 to 73.8
|
21.3 percentage of lesions arrested
Interval 13.0 to 32.8
|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Ethnicity
Not Hispanic/Latino
|
48.2 percentage of lesions arrested
Interval 36.1 to 60.6
|
24.4 percentage of lesions arrested
Interval 15.8 to 35.8
|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Ethnicity
Ethnicity Not Reported
|
63.1 percentage of lesions arrested
Interval 10.8 to 96.0
|
9.7 percentage of lesions arrested
Interval 0.6 to 66.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Data were stratified by race. Due to the small number of participants in the subgroup American Indian or Alaskan Native, the analysis model was unable to calculate estimates and confidence intervals. A simplified calculation ignoring the correlation among multiple lesions within a subject was used to obtain these estimates.
NIH-required analysis. Arrested trial lesions will be assessed by determining if the lesion is hard or soft by pressing on the lesion using a standard probe as assessed by calibrated examiners.
Outcome measures
| Measure |
Silver Diamine Fluoride (SDF)
n=414 Participants
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
n=416 Participants
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
|---|---|---|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Race
Black/African American
|
54.0 percentage of lesions arrested
Interval 34.7 to 72.2
|
26.1 percentage of lesions arrested
Interval 11.2 to 49.9
|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Race
White
|
47.3 percentage of lesions arrested
Interval 31.6 to 63.6
|
24.7 percentage of lesions arrested
Interval 13.7 to 40.3
|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Race
Asian
|
68.4 percentage of lesions arrested
Interval 35.5 to 89.5
|
14.2 percentage of lesions arrested
Interval 2.6 to 50.6
|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Race
American Indian/Alaskan Native
|
71.6 percentage of lesions arrested
Interval 4.5 to 99.3
|
75.9 percentage of lesions arrested
Interval 6.4 to 99.3
|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Race
Multiracial
|
42.4 percentage of lesions arrested
Interval 19.6 to 68.9
|
24.7 percentage of lesions arrested
Interval 11.0 to 46.6
|
|
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo by Race
Race Not Reported
|
63.3 percentage of lesions arrested
Interval 48.5 to 75.9
|
17.4 percentage of lesions arrested
Interval 8.7 to 31.7
|
Adverse Events
Silver Diamine Fluoride (SDF)
Serious events: 3 serious events
Other events: 103 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Silver Diamine Fluoride (SDF)
n=414 participants at risk
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
n=416 participants at risk
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization for Dental Abscess
|
0.24%
1/414 • 8 months
|
0.00%
0/416 • 8 months
|
|
Surgical and medical procedures
Hospitalization for Appendix Removal
|
0.24%
1/414 • 8 months
|
0.00%
0/416 • 8 months
|
|
General disorders
Hospitalization for Febrile Seizure
|
0.24%
1/414 • 8 months
|
0.00%
0/416 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to Asthma
|
0.00%
0/414 • 8 months
|
0.24%
1/416 • 8 months
|
Other adverse events
| Measure |
Silver Diamine Fluoride (SDF)
n=414 participants at risk
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Silver Diamine Fluoride: SDF will be applied twice during the study
|
Placebo
n=416 participants at risk
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Placebo: This is being compared to the SDF and will also be applied twice
|
|---|---|---|
|
Surgical and medical procedures
Other Surgical Procedure
|
0.24%
1/414 • 8 months
|
0.48%
2/416 • 8 months
|
|
Gastrointestinal disorders
Pulpal Exposure
|
1.4%
6/414 • 8 months
|
1.9%
8/416 • 8 months
|
|
Infections and infestations
Respiratory Infection
|
1.7%
7/414 • 8 months
|
1.9%
8/416 • 8 months
|
|
Skin and subcutaneous tissue disorders
Skin and Tissue Disorders
|
1.4%
6/414 • 8 months
|
0.00%
0/416 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.48%
2/414 • 8 months
|
0.24%
1/416 • 8 months
|
|
Gastrointestinal disorders
Toothache
|
8.0%
33/414 • 8 months
|
6.2%
26/416 • 8 months
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
5/414 • 8 months
|
1.9%
8/416 • 8 months
|
|
Gastrointestinal disorders
Oral Erythema
|
0.48%
2/414 • 8 months
|
0.24%
1/416 • 8 months
|
|
Gastrointestinal disorders
Oral Pain
|
0.24%
1/414 • 8 months
|
0.72%
3/416 • 8 months
|
|
Gastrointestinal disorders
Oral Ulceration
|
0.24%
1/414 • 8 months
|
0.48%
2/416 • 8 months
|
|
General disorders
Other
|
3.6%
15/414 • 8 months
|
1.4%
6/416 • 8 months
|
|
Gastrointestinal disorders
Abscess
|
8.5%
35/414 • 8 months
|
8.2%
34/416 • 8 months
|
|
Immune system disorders
Allergic Reaction
|
0.24%
1/414 • 8 months
|
0.00%
0/416 • 8 months
|
|
Gastrointestinal disorders
Constipation
|
0.24%
1/414 • 8 months
|
0.24%
1/416 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
6/414 • 8 months
|
1.2%
5/416 • 8 months
|
|
Injury, poisoning and procedural complications
Dental Trauma
|
0.48%
2/414 • 8 months
|
0.48%
2/416 • 8 months
|
|
Surgical and medical procedures
Dental Treatment
|
5.3%
22/414 • 8 months
|
4.3%
18/416 • 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.72%
3/414 • 8 months
|
0.00%
0/416 • 8 months
|
|
Infections and infestations
Ear Infection
|
0.72%
3/414 • 8 months
|
1.2%
5/416 • 8 months
|
|
Injury, poisoning and procedural complications
Extraoral Staining
|
1.2%
5/414 • 8 months
|
0.00%
0/416 • 8 months
|
|
General disorders
Fever
|
2.2%
9/414 • 8 months
|
3.8%
16/416 • 8 months
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.97%
4/414 • 8 months
|
0.96%
4/416 • 8 months
|
|
Injury, poisoning and procedural complications
Intraoral Staining
|
0.48%
2/414 • 8 months
|
0.24%
1/416 • 8 months
|
|
Gastrointestinal disorders
Nausea
|
0.24%
1/414 • 8 months
|
0.24%
1/416 • 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place