Trial Outcomes & Findings for Older Adult Effectiveness of 2 Treatments (NCT NCT03916926)
NCT ID: NCT03916926
Last Updated: 2025-08-13
Results Overview
International Caries Detection and Assessment System was the standard used to identify active caries lesions by examination at baseline by calibrated dental hygienists. ICDAS examination was then used to assess caries arrest on permanent tooth surfaces with moderate to severe lesions (ICDAS codes 3-6 with activity code 2 (active)) that received SDF or ART + FV treatment baseline. A lesion was considered arrested if, at follow-up, the activity code is 1 (inactive) or the surface is sound (code S). The mean was calculated with standard deviation for both arms.
COMPLETED
NA
568 participants
Baseline to 26 weeks
2025-08-13
Participant Flow
Forty (40) low income housing sites were randomized to one of two treatment arms, however, seven (7) were unable to participate due to logistical reasons. Adults aged 62 and older were recruited from the remaining 33 sites in Northeast Ohio from September 2019 - April 2023 to participate in the baseline dental screening (952 completed the screening). The goal was to enroll 590, but only those with active decay (568) were eligible to participate in the clinical trial phase of the study (phase 2).
Randomization was at the level of the cluster (housing facility)
Unit of analysis: Housing Sites
Participant milestones
| Measure |
A "Simple Medical Strategy" Consisting of SDF
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
Baseline Visit
STARTED
|
346 20
|
222 20
|
|
Baseline Visit
COMPLETED
|
346 18
|
222 15
|
|
Baseline Visit
NOT COMPLETED
|
0 2
|
0 5
|
|
26 Week Follow-Up Visit
STARTED
|
346 18
|
222 15
|
|
26 Week Follow-Up Visit
COMPLETED
|
284 18
|
185 15
|
|
26 Week Follow-Up Visit
NOT COMPLETED
|
62 0
|
37 0
|
|
52 Week Follow-Up Visit
STARTED
|
335 18
|
220 15
|
|
52 Week Follow-Up Visit
COMPLETED
|
291 18
|
195 15
|
|
52 Week Follow-Up Visit
NOT COMPLETED
|
44 0
|
25 0
|
Reasons for withdrawal
| Measure |
A "Simple Medical Strategy" Consisting of SDF
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
26 Week Follow-Up Visit
Missed due to COVID-19/logistical issues
|
51
|
35
|
|
26 Week Follow-Up Visit
Withdrawal by Subject
|
11
|
2
|
|
52 Week Follow-Up Visit
Missed due to COVID-19 or logistical issues
|
22
|
13
|
|
52 Week Follow-Up Visit
Withdrawal by Subject
|
22
|
12
|
Baseline Characteristics
Sex data was missing for two participants
Baseline characteristics by cohort
| Measure |
A "Simple Medical Strategy" Consisting of SDF
n=346 Participants
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
n=222 Participants
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
Total
n=568 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.13 years
STANDARD_DEVIATION 6.95 • n=346 Participants
|
68.85 years
STANDARD_DEVIATION 6.39 • n=222 Participants
|
69.63 years
STANDARD_DEVIATION 6.76 • n=568 Participants
|
|
Sex: Female, Male
Female
|
193 Participants
n=344 Participants • Sex data was missing for two participants
|
98 Participants
n=222 Participants • Sex data was missing for two participants
|
291 Participants
n=566 Participants • Sex data was missing for two participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=344 Participants • Sex data was missing for two participants
|
124 Participants
n=222 Participants • Sex data was missing for two participants
|
275 Participants
n=566 Participants • Sex data was missing for two participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=346 Participants
|
9 Participants
n=222 Participants
|
15 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
339 Participants
n=346 Participants
|
211 Participants
n=222 Participants
|
550 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=346 Participants
|
2 Participants
n=222 Participants
|
3 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=346 Participants
|
0 Participants
n=222 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=346 Participants
|
2 Participants
n=222 Participants
|
3 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=346 Participants
|
0 Participants
n=222 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
204 Participants
n=346 Participants
|
165 Participants
n=222 Participants
|
369 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=346 Participants
|
42 Participants
n=222 Participants
|
164 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=346 Participants
|
8 Participants
n=222 Participants
|
22 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=346 Participants
|
5 Participants
n=222 Participants
|
9 Participants
n=568 Participants
|
|
Region of Enrollment
United States
|
346 participants
n=346 Participants
|
222 participants
n=222 Participants
|
568 participants
n=568 Participants
|
|
Decayed Tooth Surfaces
|
5.80 decayed tooth surfaces
STANDARD_DEVIATION 7.55 • n=346 Participants
|
4.76 decayed tooth surfaces
STANDARD_DEVIATION 5.81 • n=222 Participants
|
5.39 decayed tooth surfaces
STANDARD_DEVIATION 6.93 • n=568 Participants
|
|
Tooth Pain and Sensitivity
|
0.25 scores on a scale
STANDARD_DEVIATION 0.48 • n=346 Participants
|
0.24 scores on a scale
STANDARD_DEVIATION 0.49 • n=222 Participants
|
0.24 scores on a scale
STANDARD_DEVIATION 0.48 • n=568 Participants
|
|
Geriatric Oral health Related Quality of Life
|
30.03 scores on a scale
STANDARD_DEVIATION 4.57 • n=346 Participants
|
29.78 scores on a scale
STANDARD_DEVIATION 4.88 • n=222 Participants
|
29.93 scores on a scale
STANDARD_DEVIATION 4.69 • n=568 Participants
|
PRIMARY outcome
Timeframe: Baseline to 26 weeksPopulation: Analysis was completed for the SDF (279) group and ART + FV group (184).
International Caries Detection and Assessment System was the standard used to identify active caries lesions by examination at baseline by calibrated dental hygienists. ICDAS examination was then used to assess caries arrest on permanent tooth surfaces with moderate to severe lesions (ICDAS codes 3-6 with activity code 2 (active)) that received SDF or ART + FV treatment baseline. A lesion was considered arrested if, at follow-up, the activity code is 1 (inactive) or the surface is sound (code S). The mean was calculated with standard deviation for both arms.
Outcome measures
| Measure |
A "Simple Medical Strategy" Consisting of SDF
n=279 Participants
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
n=184 Participants
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
Caries Arrest Rate
|
0.75 surfaces
Standard Deviation 0.36
|
0.91 surfaces
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksPopulation: Analysis was completed for the SDF (272) group and ART + FV group (187).
International Caries Detection and Assessment System was the standard used to identify active caries lesions by examination at baseline by calibrated dental hygienists. ICDAS examination was then used to assess caries arrest on permanent tooth surfaces with moderate to severe lesions (ICDAS codes 3-6 with activity code 2 (active)) that received SDF or ART + FV treatment baseline. A lesion was considered arrested if, at follow-up, the activity code is 1 (inactive) or the surface is sound (code S). The mean was calculated with standard deviation for both arms.
Outcome measures
| Measure |
A "Simple Medical Strategy" Consisting of SDF
n=272 Participants
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
n=187 Participants
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
Caries Arrest Rate
|
0.88 surfaces
Standard Deviation 0.25
|
0.92 surfaces
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: Baseline to 26 weeksPopulation: Analysis was completed for the SDF (284) group and ART + FV group (184) for Pain Scores at 26 weeks.
Tooth Pain and Sensitivity were assessed using the PROMIS v.1.0 - Pain Intensity 3a (Modified for Dental). A mean pain intensity score was created for the 3-item scale and ranged from 0-4 (Had no pain - 0, Mild-1, Moderate-2, Severe-3 to Very Severe - 4) and was then collapsed to 0-2 (No pain-0, mild/moderate-1, and severe/very severe-2. Higher scores indicate more pain.
Outcome measures
| Measure |
A "Simple Medical Strategy" Consisting of SDF
n=284 Participants
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
n=184 Participants
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
Tooth Pain
|
0.27 scores on a scale
Standard Deviation 0.50
|
0.21 scores on a scale
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksPopulation: Analysis was completed for the SDF (290) group and ART + FV group (192) for Pain Scores at 52 weeks.
Tooth Pain and Sensitivity were assessed using the PROMIS v.1.0 - Pain Intensity 3a (Modified for Dental). A mean pain intensity score was created for the 3-item scale and ranged from 0-4 (Had no pain - 0, Mild-1, Moderate-2, Severe-3 to Very Severe - 4) and was then collapsed to 0-2 (No pain-0, mild/moderate-1, and severe/very severe-2. Higher scores indicate more pain.
Outcome measures
| Measure |
A "Simple Medical Strategy" Consisting of SDF
n=290 Participants
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
n=192 Participants
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
Tooth Pain
|
0.21 scores on a scale
Standard Deviation 0.43
|
0.25 scores on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Analysis for SDF (281) group and ART + FV group (184) for newly decayed surfaces at 26 weeks.
New decay was defined as ICDAS lesion code ≥3 (localized to extensive decay) on one or more surfaces on teeth previously not found at baseline even on surfaces that did not receive the study treatments. ICDAS examination was used to determine the count of newly decayed surfaces on teeth and the mean was calculated.
Outcome measures
| Measure |
A "Simple Medical Strategy" Consisting of SDF
n=281 Participants
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
n=184 Participants
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
Prevention of New Decay
|
0.94 surfaces
Standard Deviation 2.03
|
0.52 surfaces
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: Analysis for SDF (282) group and ART + FV group (192) for newly decayed surfaces at 52 weeks.
New decay was defined as ICDAS lesion code ≥3 (localized to extensive decay) on one or more surfaces on teeth previously not found at baseline even on surfaces that did not receive the study treatments. ICDAS examination was used to determine the count of newly decayed surfaces on teeth and the mean was calculated.
Outcome measures
| Measure |
A "Simple Medical Strategy" Consisting of SDF
n=282 Participants
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
n=192 Participants
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
Prevention of New Decay
|
0.67 surfaces
Standard Deviation 1.72
|
0.66 surfaces
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline to 26 weeksPopulation: Analysis for SDF (284) group and ART + FV group (184) for the mean of overall GOHRQoL scores at 26 weeks.
Geriatric Oral Health Related Quality of Life (GOHRQoL) overall score is created by taking the sum of each of the 12 items, which were collected using a Likert type scale with 3 levels (Always/Often - 1, Sometimes/Seldom - 2, Never - 3). The overall scores ranged from 12-36 with higher scores indicating better quality of life. The mean was calculated for the SDF and ART groups.
Outcome measures
| Measure |
A "Simple Medical Strategy" Consisting of SDF
n=284 Participants
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
n=184 Participants
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
Oral Health Related Quality of Life
|
30.73 mean of overall scores on a scale
Standard Deviation 4.33
|
30.45 mean of overall scores on a scale
Standard Deviation 4.43
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: Analysis for SDF (290) group and ART + FV group (192) for the mean of overall GOHRQoL scores at 52 weeks.
Geriatric Oral Health Related Quality of Life (GOHRQoL) overall score is created by taking the sum of each of the 12 items, which were collected using a Likert type scale with 3 levels (Always/Often - 1, Sometimes/Seldom - 2, Never - 3). The overall scores ranged from 12-36 with higher scores indicating better quality of life. The mean was calculated for the SDF and ART groups.
Outcome measures
| Measure |
A "Simple Medical Strategy" Consisting of SDF
n=290 Participants
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
n=192 Participants
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
Oral Health Related Quality of Life
|
30.44 mean of overall scores on a scale
Standard Error 4.65
|
30.04 mean of overall scores on a scale
Standard Error 4.94
|
Adverse Events
A "Simple Medical Strategy" Consisting of SDF
A "Typical Dental Strategy" Consisting of ART + FV
Serious adverse events
| Measure |
A "Simple Medical Strategy" Consisting of SDF
n=346 participants at risk
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF (2016).
A "simple medical strategy" consisting of silver diamine fluoride (SDF): Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
|
A "Typical Dental Strategy" Consisting of ART + FV
n=222 participants at risk
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006), and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan). Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.
B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV): GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
|
|---|---|---|
|
General disorders
Death
|
4.0%
14/346 • Adverse event data was collected from baseline to the 52 week follow-up.
Adverse event information was collected for participants. Adverse events were unrelated to the intervention.
|
3.6%
8/222 • Adverse event data was collected from baseline to the 52 week follow-up.
Adverse event information was collected for participants. Adverse events were unrelated to the intervention.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place