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

Phase 4
Completed
Conditions
Caries
Interventions
Device: Silver Diamine Fluoride (SDF)
Registration Number
NCT02953886
Lead Sponsor
Heba Mitwalli
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
21
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Silver Diamine Fluoride (SDF)Silver Diamine Fluoride (SDF)Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.
Primary Outcome Measures
NameTimeMethod
Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesionsbaseline, 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.

Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)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 Outcome Measures
NameTimeMethod
Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)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.

Trial Locations

Locations (1)

University of Michigan School of Dentistry

🇺🇸

Ann Arbor, Michigan, United States

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