Stopping Cavities Study: Diammine Silver Fluoride

• ClinicalTrials.gov Identifier: NCT02536040
• Recruitment Status: Completed
• First Posted: August 31, 2015
• Results First Posted: January 23, 2020
• Last Update Posted: January 23, 2020
• Sponsor: Advantage Dental Services, LLC
• Information provided by (Responsible Party): Advantage Dental Services, LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Dental Caries
• Interventions: Drug: 38% diammine silver fluoride; Other: Water
• Enrollment: 66

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	38% Diamine Silver Fluoride	Water
Arm/Group Description	Topical application of 38% diammine silver fluoride to active cavity 38% diammine silver fluoride: treatment of cavity with study agent	Topical application of fluoride free water to active cavity Water: Fluoride free, distilled water
Period Title: Overall Study
Started	30	36
Completed	29	35
Not Completed	1	1

Baseline Characteristics

Arm/Group Title		38% Diamine Silver Fluoride	Water	Total
Arm/Group Description		Topical application of 38% diammine silver fluoride to active cavity 38% diammine silver fluoride: treatment of cavity with study agent	Topical application of fluoride free water to active cavity Water: Fluoride free, distilled water	Total of all reporting groups
Overall Number of Baseline Participants		30	36	66
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	30 participants	36 participants	66 participants
		4.7 (.6)	4.9 (.5)	4.8 (.6)
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	35 participants	64 participants
	Female	13 44.8%	18 51.4%	31 48.4%
	Male	16 55.2%	17 48.6%	33 51.6%
		[1] Measure Analysis Population Description: One participant without follow-up excluded from placebo group: male One participant without follow-up excluded: female
Ethnicity (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	35 participants	64 participants
	Hispanic or Latino	15 51.7%	23 65.7%	38 59.4%
	Not Hispanic or Latino	14 48.3%	12 34.3%	26 40.6%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
		[1] Measure Analysis Population Description: 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) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	35 participants	64 participants
	American Indian or Alaska Native	2 6.9%	0 0.0%	2 3.1%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	27 93.1%	33 94.3%	60 93.8%
	More than one race	0 0.0%	2 5.7%	2 3.1%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
		[1] Measure Analysis Population Description: One participant without follow-up excluded from placebo: White One participant without follow-up excluded from test: White
Region of Enrollment [1]; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	29 participants	35 participants	64 participants
		29	35	64
		[1] Measure Analysis Population Description: Two subjects excluded without follow-up: United States

Outcome Measures

1. Primary Outcome

Title	Dental Caries Activity
Description	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
Time Frame	14-21 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	38% Diamine Silver Fluoride	Water
Arm/Group Description:	Topical application of 38% diammine silver fluoride to active cavity 38% diammine silver fluoride: treatment of cavity with study agent	Topical application of fluoride free water to active cavity Water: Fluoride free, distilled water
Overall Number of Participants Analyzed	29	35
Mean (Standard Deviation); Unit of Measure: Proportion of arrested caries lesions
	.72 (.38)	.05 (.18)

Adverse Events

Time Frame	The primary focus of the adverse events clinical examination was to detect intramural soft tissue changes 2 days following the localized treatment of the teeth. It was not measured 14-21 days later when the primary outcome was assessed.
Adverse Event Reporting Description	Primary focus of adverse event assessment was intramural changes associated with the localized topical treatment of the teeth ((infection, inflammation, ulceration).
Arm/Group Title	38% Diamine Silver Fluoride	Water
Arm/Group Description	Topical application of 38% diammine silver fluoride to active cavity 38% diammine silver fluoride: treatment of cavity with study agent	Topical application of fluoride free water to active cavity Water: Fluoride free, distilled water
All-Cause Mortality
	38% Diamine Silver Fluoride	Water
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/29 (0.00%)	0/35 (0.00%)
Serious Adverse Events
	38% Diamine Silver Fluoride	Water
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/29 (0.00%)	0/35 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	38% Diamine Silver Fluoride	Water
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/29 (0.00%)	0/35 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Peter Milgrom
• Organization: Advantage Silver Dental Arrest, LLC
• Phone: 2062516831
• EMail: drmilgrom@silverarrest.com

• Responsible Party: Advantage Dental Services, LLC
• ClinicalTrials.gov Identifier: NCT02536040
• Other Study ID Numbers: 003
• First Submitted: August 27, 2015
• First Posted: August 31, 2015
• Results First Submitted: January 6, 2020
• Results First Posted: January 23, 2020
• Last Update Posted: January 23, 2020