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

NCT02953886 | Completed Phase 4 Results FDA Device

• 1 other identifier: HUM00117560
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Caries

Keywords

Caries; Cavity; Silver Diamine Fluoride (SDF); HOMINGS

Outcome Measures

Primary Outcomes (2)

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

  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.

  baseline, One month after SDF

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

  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.

  One month

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)

  One month

Study Arms (1)

Silver Diamine Fluoride (SDF)

EXPERIMENTAL

Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.

Device: Silver Diamine Fluoride (SDF)

Interventions

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

Also known as: Silver Dental Arrest

Silver Diamine Fluoride (SDF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heba Mitwalli: lead
• The Forsyth Institute: collaborator

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

• Title: Emily Yanca
• Organization: University of Michigan

emthorpe@umich.edu

734-763-3988

Study Officials

• Heba Mitwalli, DDS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Margherita Fontana, DDS, PhD

  University of Michigan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS, Master's Student

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 3, 2016
• Study Start: November 1, 2016
• Primary Completion: April 20, 2017
• Study Completion: April 20, 2017
• Last Updated: September 28, 2018
• Results First Posted: June 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)