Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series

The authors conducted a case series to determine the outcomes of treatment of root surface caries lesions when the teeth were treated topically with 38% silver diamine fluoride.

Study Overview

• Status: Completed
• Conditions: Root Caries
• Intervention / Treatment: Device: Silver Diamine Fluoride 38%

Detailed Description

The study is a prospective, single center case series. The cases were consecutive. Participation was offered to every patient who qualified based on age and the presence of an active lesion in a root surfaces, in a furcation, or under an individual crown or crown abutment for a fixed prosthesis. The study was conducted at the dental clinic of the Roseman College of Dental Medicine in South Jordan, Utah. The University of California, San Francisco protocol for applying topical silver diamine fluoride was adapted for use with these patients. Lesions were flushed with water and then dried with compressed air, isolated with cotton rolls, and then 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care, West Palm Beach, FL) was applied repeatedly for two minutes with the manufacturer supplied dental applicator. The silver diamine fluoride was stored under the manufacturer's recommended conditions. If the patient complained about the taste, the lesion was coated with sodium fluoride varnish. All of the lesions were reevaluated for dental caries lesion activity about every six months and retreated regardless of their arrest status. Follow-up was for 30 months or until loss to follow-up.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 1 active root surface caries lesion by Nyvad criteria

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Silver Diamine Fluoride; Topical application of one drop of silver diamine fluoride 38% to active untreated roof surface caries, lesions at the furcation, or lesions at crown margins. Application was repeated once each six months.	Device: Silver Diamine Fluoride 38%; Dental caries arrest medication; Other Names: Advantage Silver Arrest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental caries lesion activity 1	Nyvad score based on visual/tactile examination	6-12 months
Dental caries lesion activity 2	Nyvad score based on visual/tactile examination	<6 months
Dental caries lesion activity 3	Nyvad score based on visual/tactile examination	12-18 months
Dental caries lesion activity 4	Nyvad score based on visual/tactile examination	18-24 months
Dental caries lesion activity 5	Nyvad score based on visual/tactile examination	24-30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries lesion fluorescence 1	Laser fluorescence measurement at the surface of the lesion	<6 months
Caries lesion fluorescence 2	Laser fluorescence measurement at the surface of the lesion	6-12 months
Caries lesion fluorescence 3	Laser fluorescence measurement at the surface of the lesion	12-18 months
Caries lesion fluorescence 4	Laser fluorescence measurement at the surface of the lesion	18-24 months
Caries lesion fluorescence 5	Laser fluorescence measurement at the surface of the lesion	24-30 months

Collaborators and Investigators

• Sponsor: Roseman University of Health Sciences
• Investigators: Principal Investigator: David Prince, DDS, Roseman Health Sciences University

Publications and helpful links

General Publications

• Nyvad B, Machiulskiene V, Baelum V. Reliability of a new caries diagnostic system differentiating between active and inactive caries lesions. Caries Res. 1999 Jul-Aug;33(4):252-60. doi: 10.1159/000016526.
• Mitchell C, Gross AJ, Milgrom P, Mancl L, Prince DB. Silver diamine fluoride treatment of active root caries lesions in older adults: A case series. J Dent. 2021 Feb;105:103561. doi: 10.1016/j.jdent.2020.103561. Epub 2020 Dec 24.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2017
• Primary Completion (ACTUAL): November 21, 2019
• Study Completion (ACTUAL): November 21, 2019

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (ACTUAL): April 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Root Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 1122117-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No