Skip to main content
OpenTrials
Completed

NCT Number: NCT02953886

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Caries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Generally healthy adult participants 18 years of age and older.
  • At least one tooth with active (soft) cavitated lesions of ICDAS score 5 or 6 near the gingival margin (coronal cervical caries at the CEJ or exposed root surfaces with soft active carious lesions exposing dentin).

Exclusion criteria

  • Adult participants who suffer from serious life-threatening medical diseases that interfere with basic daily self care activities.
  • Patients taking antibiotics within the last two weeks.
  • Patients using chlorhexidine or fluoride mouth washes within the last two weeks.
  • Pregnant or breastfeeding women.
  • Teeth with arrested (hard) cervical or root caries lesions.
  • Teeth that have been diagnosed with an abscess or an irreversible pulpitis, or are mobile.

Treatment and study plan

Silver Diamine Fluoride (SDF)

Device

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

Other names: Silver Dental Arrest

Primary outcomes

  1. Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions

    Time frame: baseline, One month after SDF

    Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application.

  2. Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)

    Time frame: One month

    Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below.

Secondary outcomes

  1. Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)

    Time frame: One month

    Each subject was asked if they were concerned with the appearance of the tooth that SDF was applied too. They were also asked if they wanted the study tooth to be filled with a tooth color filling.

Sponsors and collaborators

Lead sponsor

Heba Mitwalli

Other

Collaborators

  • The Forsyth Institute

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2016
Registry last updated
Sep 28, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.