NCT04370080

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

April 23, 2020

Last Update Submit

April 29, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Caries lesion fluorescence 1

    <6 months

  • Caries lesion fluorescence 2

    6-12 months

  • Caries lesion fluorescence 3

    12-18 months

  • Caries lesion fluorescence 4

    18-24 months

  • Caries lesion fluorescence 5

    24-30 months

Study Arms (1)

Silver Diamine Fluoride

EXPERIMENTAL

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%

Interventions

Dental caries arrest medication

Also known as: Advantage Silver Arrest
Silver Diamine Fluoride

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 10343087BACKGROUND
  • 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.

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental CariesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • David Prince, DDS

    Roseman Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Case series, consecutive
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 30, 2020

Study Start

January 3, 2017

Primary Completion

November 21, 2019

Study Completion

November 21, 2019

Last Updated

April 30, 2020

Record last verified: 2020-04