Trial Outcomes & Findings for A Clinical Trial of Silver Diamine Fluoride to Arrest Early Childhood Caries in Young Children (NCT NCT04054635)
NCT ID: NCT04054635
Last Updated: 2023-09-13
Results Overview
Total number of lesions arrested/total number of lesions treated
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
8 months, 12 months, and 2 months
Results posted on
2023-09-13
Participant Flow
Participants under 72 months of age with early childhood caries were recruited between October 2019 and June 2021 from community dental clinics in Winnipeg, Manitoba, Canada (Access Downtown, Mount Carmel Clinic, and SMILE Plus Children's Dental Clinic). Study visits took place at these clinics or at the Children's Hospital Research Institute of Manitoba.
Children were not approached if: caries were not ICDAS (international caries detection and assessment system) codes 5/6; affected teeth met PUFA (pulpal involvement, ulceration, fistula, and abscess) index criteria; children had allergy/sensitivity to silver/heavy metal ions, developmental defects of enamel, severe medical issues, used antibiotics within two weeks of recruitment, or required immediate rehabilitation under general anesthesia. Participants were randomized using sealed envelopes.
Participant milestones
| Measure |
Regimen 1
Two applications of silver diamine fluoride (SDF) four months apart, which is the protocol frequency adopted by the Winnipeg Regional Health Authority's (WRHA) Clinical Guideline on SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 2
Two applications of silver diamine fluoride (SDF) six months apart, which is the American Dental Association's recommendation for SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 3
Two applications of silver diamine fluoride (SDF) one month apart, which is proposed in the American Academy of Pediatric Dentistry's clinical practice guidelines.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
|---|---|---|---|
|
First Visit (Baseline)
STARTED
|
28
|
28
|
28
|
|
First Visit (Baseline)
COMPLETED
|
28
|
28
|
28
|
|
First Visit (Baseline)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Visit (First Follow-up)
STARTED
|
28
|
28
|
28
|
|
Second Visit (First Follow-up)
COMPLETED
|
28
|
27
|
28
|
|
Second Visit (First Follow-up)
NOT COMPLETED
|
0
|
1
|
0
|
|
Third Visit (Second Follow-up)
STARTED
|
28
|
27
|
28
|
|
Third Visit (Second Follow-up)
COMPLETED
|
27
|
27
|
28
|
|
Third Visit (Second Follow-up)
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Regimen 1
Two applications of silver diamine fluoride (SDF) four months apart, which is the protocol frequency adopted by the Winnipeg Regional Health Authority's (WRHA) Clinical Guideline on SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 2
Two applications of silver diamine fluoride (SDF) six months apart, which is the American Dental Association's recommendation for SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 3
Two applications of silver diamine fluoride (SDF) one month apart, which is proposed in the American Academy of Pediatric Dentistry's clinical practice guidelines.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
|---|---|---|---|
|
Second Visit (First Follow-up)
Lost to Follow-up
|
0
|
1
|
0
|
|
Third Visit (Second Follow-up)
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Trial of Silver Diamine Fluoride to Arrest Early Childhood Caries in Young Children
Baseline characteristics by cohort
| Measure |
Regimen 1
n=28 Participants
Two applications of silver diamine fluoride (SDF) four months apart, which is the protocol frequency adopted by the Winnipeg Regional Health Authority's (WRHA) Clinical Guideline on SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 2
n=28 Participants
Two applications of silver diamine fluoride (SDF) six months apart, which is the American Dental Association's recommendation for SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 3
n=28 Participants
Two applications of silver diamine fluoride (SDF) one month apart, which is proposed in the American Academy of Pediatric Dentistry's clinical practice guidelines.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.5 months
STANDARD_DEVIATION 12.6 • n=5 Participants
|
48.9 months
STANDARD_DEVIATION 14.2 • n=7 Participants
|
43.9 months
STANDARD_DEVIATION 15.0 • n=5 Participants
|
44.4 months
STANDARD_DEVIATION 14.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Background · African
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Background · Asian
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Background · European
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Background · Indigenous
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Newcomer to Canada
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Frequency of tooth brushing
Twice daily
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Frequency of tooth brushing
Once daily
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Frequency of tooth brushing
Less than once a day
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Use of fluoridated toothpaste
Yes
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Use of fluoridated toothpaste
No
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Use of fluoridated toothpaste
Do not know
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Has dental insurance
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Has tooth pain
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Total number of teeth treated
|
121 teeth
n=5 Participants
|
110 teeth
n=7 Participants
|
143 teeth
n=5 Participants
|
374 teeth
n=4 Participants
|
|
Total number of lesions treated
|
166 lesions
n=5 Participants
|
143 lesions
n=7 Participants
|
196 lesions
n=5 Participants
|
505 lesions
n=4 Participants
|
|
Mean number of teeth treated
|
4.3 teeth
STANDARD_DEVIATION 3.1 • n=5 Participants
|
7.6 teeth
STANDARD_DEVIATION 19.9 • n=7 Participants
|
5.1 teeth
STANDARD_DEVIATION 2.7 • n=5 Participants
|
4.6 teeth
STANDARD_DEVIATION 2.8 • n=4 Participants
|
|
Mean number of lesions treated
|
5.9 lesions
STANDARD_DEVIATION 5.2 • n=5 Participants
|
5.1 lesions
STANDARD_DEVIATION 4.1 • n=7 Participants
|
7.0 lesions
STANDARD_DEVIATION 4.8 • n=5 Participants
|
6.0 lesions
STANDARD_DEVIATION 4.7 • n=4 Participants
|
|
Mean dmft
|
6.2 dmft index
STANDARD_DEVIATION 4.7 • n=5 Participants
|
7.3 dmft index
STANDARD_DEVIATION 4.1 • n=7 Participants
|
7.0 dmft index
STANDARD_DEVIATION 4.7 • n=5 Participants
|
6.8 dmft index
STANDARD_DEVIATION 4.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8 months, 12 months, and 2 monthsTotal number of lesions arrested/total number of lesions treated
Outcome measures
| Measure |
Regimen 1
n=166 lesions
Two applications of silver diamine fluoride (SDF) four months apart, which is the protocol frequency adopted by the Winnipeg Regional Health Authority's (WRHA) Clinical Guideline on SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 2
n=143 lesions
Two applications of silver diamine fluoride (SDF) six months apart, which is the American Dental Association's recommendation for SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 3
n=196 lesions
Two applications of silver diamine fluoride (SDF) one month apart, which is proposed in the American Academy of Pediatric Dentistry's clinical practice guidelines.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
|---|---|---|---|
|
Overall Arrest Rates
Second visit (first follow-up)
|
81.3 percentage of lesions arrested
|
61.5 percentage of lesions arrested
|
78.1 percentage of lesions arrested
|
|
Overall Arrest Rates
Third visit (second follow-up)
|
95.8 percentage of lesions arrested
|
72.0 percentage of lesions arrested
|
98.0 percentage of lesions arrested
|
PRIMARY outcome
Timeframe: 8 months, 12 months, and 2 monthsTotal number of anterior lesions arrested/total number of anterior lesions treated.
Outcome measures
| Measure |
Regimen 1
n=94 lesions
Two applications of silver diamine fluoride (SDF) four months apart, which is the protocol frequency adopted by the Winnipeg Regional Health Authority's (WRHA) Clinical Guideline on SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 2
n=73 lesions
Two applications of silver diamine fluoride (SDF) six months apart, which is the American Dental Association's recommendation for SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 3
n=133 lesions
Two applications of silver diamine fluoride (SDF) one month apart, which is proposed in the American Academy of Pediatric Dentistry's clinical practice guidelines.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
|---|---|---|---|
|
Anterior Teeth Arrest Rates
Second visit (first follow-up)
|
83.0 percentage of lesions arrested
|
75.3 percentage of lesions arrested
|
85.0 percentage of lesions arrested
|
|
Anterior Teeth Arrest Rates
Third visit (second follow-up)
|
97.9 percentage of lesions arrested
|
74.0 percentage of lesions arrested
|
99.2 percentage of lesions arrested
|
PRIMARY outcome
Timeframe: 8 months, 12 months, and 2 monthsTotal number of posterior lesions arrested/total number of posterior lesions treated.
Outcome measures
| Measure |
Regimen 1
n=72 lesions
Two applications of silver diamine fluoride (SDF) four months apart, which is the protocol frequency adopted by the Winnipeg Regional Health Authority's (WRHA) Clinical Guideline on SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 2
n=70 lesions
Two applications of silver diamine fluoride (SDF) six months apart, which is the American Dental Association's recommendation for SDF.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
Regimen 3
n=63 lesions
Two applications of silver diamine fluoride (SDF) one month apart, which is proposed in the American Academy of Pediatric Dentistry's clinical practice guidelines.
Silver diamine fluoride: Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
|
|---|---|---|---|
|
Posterior Arrest Rates
Second visit (first follow-up)
|
79.2 percentage of lesions arrested
|
48.6 percentage of lesions arrested
|
63.5 percentage of lesions arrested
|
|
Posterior Arrest Rates
Third visit (second follow-up)
|
93.1 percentage of lesions arrested
|
70.0 percentage of lesions arrested
|
95.2 percentage of lesions arrested
|
Adverse Events
Regimen 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place