Trial Outcomes & Findings for Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions (NCT NCT03649659)
NCT ID: NCT03649659
Last Updated: 2025-01-07
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
2025-01-07
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=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Customized
Child Age 2 Years
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Age, Customized
Child Age 3 Years
|
124 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Age, Customized
Child Age 4 Years
|
155 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
325 Participants
n=5 Participants
|
|
Age, Customized
Child Age 5 Years
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
228 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
428 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
402 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
182 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
228 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
447 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 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
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
24 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
138 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
414 participants
n=5 Participants
|
416 participants
n=7 Participants
|
830 participants
n=5 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
|
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
|
|---|---|---|
|
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
|
|
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
|
|
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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place