Trial Outcomes & Findings for Stopping Cavities Study: Diammine Silver Fluoride (NCT NCT02536040)

NCT ID: NCT02536040

Last Updated: 2020-01-23

Results Overview

Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 66 participants
• Primary outcome timeframe: 14-21 days
• Results posted on: 2020-01-23

Participant Flow

Participant milestones

Measure	38% Diamine Silver Fluoride Topical application of 38% diammine silver fluoride to active cavity 38% diammine silver fluoride: treatment of cavity with study agent	Water Topical application of fluoride free water to active cavity Water: Fluoride free, distilled water
Overall Study STARTED	30	36
Overall Study COMPLETED	29	35
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant without follow-up excluded from placebo group: male One participant without follow-up excluded: female

Baseline characteristics by cohort

Measure	38% Diamine Silver Fluoride n=30 Participants Topical application of 38% diammine silver fluoride to active cavity 38% diammine silver fluoride: treatment of cavity with study agent	Water n=36 Participants Topical application of fluoride free water to active cavity Water: Fluoride free, distilled water	Total n=66 Participants Total of all reporting groups
Age, Continuous	4.7 years STANDARD_DEVIATION .6 • n=30 Participants	4.9 years STANDARD_DEVIATION .5 • n=36 Participants	4.8 years STANDARD_DEVIATION .6 • n=66 Participants
Sex: Female, Male Female	13 Participants n=29 Participants • One participant without follow-up excluded from placebo group: male One participant without follow-up excluded: female	18 Participants n=35 Participants • One participant without follow-up excluded from placebo group: male One participant without follow-up excluded: female	31 Participants n=64 Participants • One participant without follow-up excluded from placebo group: male One participant without follow-up excluded: female
Sex: Female, Male Male	16 Participants n=29 Participants • One participant without follow-up excluded from placebo group: male One participant without follow-up excluded: female	17 Participants n=35 Participants • One participant without follow-up excluded from placebo group: male One participant without follow-up excluded: female	33 Participants n=64 Participants • One participant without follow-up excluded from placebo group: male One participant without follow-up excluded: female
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=29 Participants • One participant without follow-up excluded from placebo group: not hispanic or latino One participant without follow-up excluded from test group: hispanic or latino	23 Participants n=35 Participants • One participant without follow-up excluded from placebo group: not hispanic or latino One participant without follow-up excluded from test group: hispanic or latino	38 Participants n=64 Participants • One participant without follow-up excluded from placebo group: not hispanic or latino One participant without follow-up excluded from test group: hispanic or latino
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=29 Participants • One participant without follow-up excluded from placebo group: not hispanic or latino One participant without follow-up excluded from test group: hispanic or latino	12 Participants n=35 Participants • One participant without follow-up excluded from placebo group: not hispanic or latino One participant without follow-up excluded from test group: hispanic or latino	26 Participants n=64 Participants • One participant without follow-up excluded from placebo group: not hispanic or latino One participant without follow-up excluded from test group: hispanic or latino
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=29 Participants • One participant without follow-up excluded from placebo group: not hispanic or latino One participant without follow-up excluded from test group: hispanic or latino	0 Participants n=35 Participants • One participant without follow-up excluded from placebo group: not hispanic or latino One participant without follow-up excluded from test group: hispanic or latino	0 Participants n=64 Participants • One participant without follow-up excluded from placebo group: not hispanic or latino One participant without follow-up excluded from test group: hispanic or latino
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=29 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	0 Participants n=35 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	2 Participants n=64 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White
Race (NIH/OMB) Asian	0 Participants n=29 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	0 Participants n=35 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	0 Participants n=64 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=29 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	0 Participants n=35 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	0 Participants n=64 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White
Race (NIH/OMB) Black or African American	0 Participants n=29 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	0 Participants n=35 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	0 Participants n=64 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White
Race (NIH/OMB) White	27 Participants n=29 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	33 Participants n=35 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	60 Participants n=64 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White
Race (NIH/OMB) More than one race	0 Participants n=29 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	2 Participants n=35 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	2 Participants n=64 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=29 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	0 Participants n=35 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White	0 Participants n=64 Participants • One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White
Region of Enrollment United States	29 participants n=29 Participants • Two subjects excluded without follow-up: United States	35 participants n=35 Participants • Two subjects excluded without follow-up: United States	64 participants n=64 Participants • Two subjects excluded without follow-up: United States

PRIMARY outcome

Timeframe: 14-21 days

Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change

Outcome measures

Measure	38% Diamine Silver Fluoride n=29 Participants Topical application of 38% diammine silver fluoride to active cavity 38% diammine silver fluoride: treatment of cavity with study agent	Water n=35 Participants Topical application of fluoride free water to active cavity Water: Fluoride free, distilled water
Dental Caries Activity	.72 Proportion of arrested caries lesions Standard Deviation .38	.05 Proportion of arrested caries lesions Standard Deviation .18

Adverse Events

38% Diamine Silver Fluoride

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Water

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

Peter Milgrom

Advantage Silver Dental Arrest, LLC

Phone: 2062516831

Email: drmilgrom@silverarrest.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place