MedDataX Logo

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

NCT ID: NCT04370080

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-03

Study Completion Date

2019-11-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Root Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Case series, consecutive
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Silver Diamine Fluoride 38%

Intervention Type DEVICE

Dental caries arrest medication

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Silver Diamine Fluoride 38%

Dental caries arrest medication

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Advantage Silver Arrest

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Roseman University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Prince

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Prince, DDS

Role: PRINCIPAL_INVESTIGATOR

Roseman Health Sciences University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 10343087 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33347946 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1122117-4

Identifier Type: -

Identifier Source: org_study_id