Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques

October 22, 2021 updated by: Margherita Fontana, University of Michigan

The Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques: A 12 Month Randomized Controlled Trial

The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF) for treatment of cavities in baby teeth. The investigators will compare the effectiveness of stopping the cavity, cost of the treatments and the opinions of the families and the dental providers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine the effectiveness of the application of silver diamine fluoride (SDF) in comparison to conventional restorative treatments in International Caries Detection and Assessment System criteria (ICDAS) 5 and 6, one and two surface carious lesions in primary molars which will be assessed based on major and minor failure criteria when followed for one year. Additionally, parents'/children's and providers' perceptions will be assessed as well as the cost of both regimens, to include both chair time spent and materials' costs.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry
      • Flint, Michigan, United States, 48503
        • Mott Children's Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of at least one active (soft) cavitated carious lesions in the primary dentition, extending into dentin (ICDAS 5 or 6)
  • The selected tooth must have a one or two surface lesion (more than 1/3 of the crown of the tooth must be remaining) and must allow for direct application of SDF
  • Study teeth will not have any spontaneous or elicited pain due to caries, tooth mobility, or signs of pulpal infection
  • Selected primary teeth must have an anticipated exfoliation date greater than 12 months away

Exclusion Criteria:

  • Hereditary developmental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
  • Severe medical conditions that do not allow the child to be managed in the clinic
  • Known allergy /sensitivity to dental materials being used, including SDF
  • Inability of the child to cooperate for treatment, recall examinations, or periapical radiographs
  • Wards of the State, for consenting reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silver Diamine Fluoride
This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries.
Device: Silver Diamine Fluoride
No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet.
Other Names:
  • Silver Dental Arrest
Active Comparator: Conventional Caries Management
Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.
Procedure: Conventional Caries Management
These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.
Other Names:
  • Filling
  • Restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries Arrest of Teeth in the SDF Group Measured by Change in Size
Time Frame: 12 Months

Number of participants in the SDF arm that had an increase in lesion size at any point in the 12 months of the trial, as this is a treatment failure.

Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were then removed from the trial for further clinical treatment.
12 Months
Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)
Time Frame: 12 Months
Color of the cavity at the end of the trial
12 Months
Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard)
Time Frame: 12 Months

Texture of the cavity's dentin of soft means the cavity is still an active infection. If the cavity is hard, the cavity is no longer an active infection (has been arrested).

Please note dentin texture cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment.
12 Months
Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)
Time Frame: 12 Months

Secondary caries, lost restorations, or restorations needing repair are treatment failures.

Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.
12 Months
Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)
Time Frame: 12 Months
Signs of pulpal pathology are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)
Time Frame: Baseline
Data collected at baseline only.
Baseline
Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)
Time Frame: Baseline
Baseline
Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)
Time Frame: Baseline
Baseline
Parent Assessment of Appearance of Child's Teeth
Time Frame: 12 Months
Parents were asked "Are you concerned with the appearance of your child's teeth?"
12 Months
Parent Assessment of Treatment Provided
Time Frame: 12 Months
Parents were asked "If your child had another cavity, would you be willing to have that tooth treated with the same treatment option provided to your child in this study?"
12 Months
Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)
Time Frame: 12 Months
12 Months
Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)
Time Frame: 12 Months
12 Months
Costs of Treatment (Dollars)
Time Frame: Baseline
Cost of one application of SDF and one 1-2 surface conventional restoration. Cost was calculated by taking the average Medicaid reimbursement across all U.S. states.
Baseline
Time of Treatment Procedures (Duration of Time in Minutes)
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Mott Children's Health Center

Investigators

  • Principal Investigator: Margherita R Fontana, DDS, PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 18, 2020

Study Completion (Actual)

September 18, 2020

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00097829

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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