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

NCT ID: NCT02953886

Last Updated: 2018-09-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-04-20

Brief Summary

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

Detailed Description

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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

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Caries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Silver Diamine Fluoride (SDF)

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Silver Dental Arrest

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Forsyth Institute

OTHER

Sponsor Role collaborator

Heba Mitwalli

OTHER

Sponsor Role lead

Responsible Party

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Heba Mitwalli

DDS, Master's Student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Heba Mitwalli, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Margherita Fontana, DDS, PhD

Role: STUDY_CHAIR

University of Michigan

Locations

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University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HUM00117560

Identifier Type: -

Identifier Source: org_study_id

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