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

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953886
• Other study ID #: HUM00117560
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: April 20, 2017

Study information

• Verified date: September 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 20, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caries
• Dental Caries

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Heba Mitwalli	The Forsyth Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)	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.	One month