Clinical trial NCT04370080: Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series
Official title: Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Caries
Lead sponsor: Roseman University of Health Sciences
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 63
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series, consecutive
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Dental caries lesion activity 1
timeFrame: 6-12 months
measure: Dental caries lesion activity 2
timeFrame: <6 months
measure: Dental caries lesion activity 3
timeFrame: 12-18 months
measure: Dental caries lesion activity 4
timeFrame: 18-24 months
measure: Dental caries lesion activity 5
timeFrame: 24-30 months
Secondary outcomes:
measure: Caries lesion fluorescence 1
timeFrame: <6 months
measure: Caries lesion fluorescence 2
timeFrame: 6-12 months
measure: Caries lesion fluorescence 3
timeFrame: 12-18 months
measure: Caries lesion fluorescence 4
timeFrame: 18-24 months
measure: Caries lesion fluorescence 5
timeFrame: 24-30 months
Other outcomes:
Locations:
Study officials:
affiliation: Roseman Health Sciences University
name: David Prince, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.