NCT02953886

The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions

The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions Using HOMINGS Technology. A Clinical Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Heba Mitwalli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment.

Detailed description

To assess the effect of silver diamine fluoride (SDF) treatment on microorganisms present in root caries or cervical lesions by collecting microbial deposits before and 1 month after SDF application. Bacterial samples will be collected from 20 adult subjects at the initial visit before application of SDF and one month after. At the 1 month recall, examination for caries arrest will be performed. All 40 bacterial samples will be sent to the Forsyth Institute to verify bacterial composition using HOMINGS technology.

Conditions

• Caries

Interventions

Type	Name	Description
DEVICE	Silver Diamine Fluoride (SDF)	No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-04-20
• Completion: 2017-04-20
• First posted: 2016-11-03
• Last updated: 2018-09-28
• Results posted: 2018-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study