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OpenTrials
Completed

NCT Number: NCT04370080

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Silver Diamine Fluoride 38%

Device

Dental caries arrest medication

Other names: Advantage Silver Arrest

Primary outcomes

  1. Dental caries lesion activity 1

    Time frame: 6-12 months

    Nyvad score based on visual/tactile examination

  2. Dental caries lesion activity 2

    Time frame: <6 months

    Nyvad score based on visual/tactile examination

  3. Dental caries lesion activity 3

    Time frame: 12-18 months

    Nyvad score based on visual/tactile examination

  4. Dental caries lesion activity 4

    Time frame: 18-24 months

    Nyvad score based on visual/tactile examination

  5. Dental caries lesion activity 5

    Time frame: 24-30 months

    Nyvad score based on visual/tactile examination

Secondary outcomes

  1. Caries lesion fluorescence 1

    Time frame: <6 months

    Laser fluorescence measurement at the surface of the lesion

  2. Caries lesion fluorescence 2

    Time frame: 6-12 months

    Laser fluorescence measurement at the surface of the lesion

  3. Caries lesion fluorescence 3

    Time frame: 12-18 months

    Laser fluorescence measurement at the surface of the lesion

  4. Caries lesion fluorescence 4

    Time frame: 18-24 months

    Laser fluorescence measurement at the surface of the lesion

  5. Caries lesion fluorescence 5

    Time frame: 24-30 months

    Laser fluorescence measurement at the surface of the lesion

Sponsors and collaborators

Lead sponsor

Roseman University of Health Sciences

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2020
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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