Stopping Cavities Study: Diammine Silver Fluoride

• Sponsor: Advantage Dental Services, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02536040
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 11

Study Details

Study Description

Brief Summary

This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Drug: 38% diammine silver fluoride; Other: Water	Phase 3

Detailed Description

Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 38% diamine silver fluoride Topical application of 38% diammine silver fluoride to active cavity	Drug: 38% diammine silver fluoride; treatment of cavity with study agent; Other Names: silver fluoride silver diamine fluoride
Placebo Comparator: Water Topical application of fluoride free water to active cavity	Other: Water; Fluoride free, distilled water

Outcome Measures

Primary Outcome Measures

1. Dental Caries Activity [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Months to 60 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Nyvad criteria 3

• Active carious lesion

Exclusion Criteria:

• Allergy to silver

• Stomatitis or oral ulcerative condition

• Weight less than 15 kg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advantage Dental Plans	Redmond	Oregon	United States	97756

Sponsors and Collaborators

• Advantage Dental Services, LLC

Investigators

• Study Director: Peter Milgrom, DDS, Advantage Dental Plans

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Advantage Dental Services, LLC
• ClinicalTrials.gov Identifier: NCT02536040
• Other Study ID Numbers: 003
• First Posted: Aug 31, 2015
• Last Update Posted: Jan 23, 2020
• Last Verified: Aug 1, 2016

• Keywords provided by Advantage Dental Services, LLC: silver diamine fluoride; diammine silver fluoride; children
• Additional relevant MeSH terms: Dental Caries; Fluorides

Study Results

Participant Flow

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 Participants	30	36	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.7 (.6)	4.9 (.5)	4.8 (.6)
Sex: Female, Male (Count of Participants)
Female	13 43.3%	18 50%	31 47%
Male	16 53.3%	17 47.2%	33 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 50%	23 63.9%	38 57.6%
Not Hispanic or Latino	14 46.7%	12 33.3%	26 39.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 6.7%	0 0%	2 3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	27 90%	33 91.7%	60 90.9%
More than one race	0 0%	2 5.6%	2 3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	29 96.7%	35 97.2%	64 97%

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
Measure Participants	29	35
Mean (Standard Deviation) [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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/35 (0%)
Serious Adverse Events
	38% Diamine Silver Fluoride		Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	38% Diamine Silver Fluoride		Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/35 (0%)

Limitations/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.