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

Root Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370080
• Other study ID #: 1122117-4
• Status: Completed
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: November 21, 2019

Study information

• Verified date: April 2020
• Source: Roseman University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 21, 2019
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Root Caries

Intervention

Device:
• Silver Diamine Fluoride 38%
Dental caries arrest medication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Roseman University of Health Sciences

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental caries lesion activity 1	Nyvad score based on visual/tactile examination	6-12 months
Primary	Dental caries lesion activity 2	Nyvad score based on visual/tactile examination	<6 months
Primary	Dental caries lesion activity 3	Nyvad score based on visual/tactile examination	12-18 months
Primary	Dental caries lesion activity 4	Nyvad score based on visual/tactile examination	18-24 months
Primary	Dental caries lesion activity 5	Nyvad score based on visual/tactile examination	24-30 months
Secondary	Caries lesion fluorescence 1	Laser fluorescence measurement at the surface of the lesion	<6 months
Secondary	Caries lesion fluorescence 2	Laser fluorescence measurement at the surface of the lesion	6-12 months
Secondary	Caries lesion fluorescence 3	Laser fluorescence measurement at the surface of the lesion	12-18 months
Secondary	Caries lesion fluorescence 4	Laser fluorescence measurement at the surface of the lesion	18-24 months
Secondary	Caries lesion fluorescence 5	Laser fluorescence measurement at the surface of the lesion	24-30 months