Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth

April 8, 2020 updated by: Nourhan M.Aly

Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth: A Randomized Clinical Trial

The purpose of this study is to evaluate the effectiveness of silver diamine fluoride (SDF) compared to chlorhexidine (CHX) as a cavity disinfectant in primary molars after Atraumatic Restorative Treatment approach (ART).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a three arm randomized controlled clinical trial, where children with an age range of 4-6 years indicated for Atraumatic Restorative Treatment (ART) are selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. Sixty teeth are randomly allocated into 3 groups of Atraumatic restorative treatment approaches. Group I is assigned to silver diamine fluoride as an antibacterial agent, Group II is assigned to chlorhexidine as an antibacterial agent, and Group III serves as a negative control.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

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

  • Egypt
      • Alexandria, Egypt, 21512
        • Faculty of Dentistry, Alexandria University

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

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children free of any systemic disease or special health care needs.
  • Class I cavity involving dentin in primary molars.
  • Lesion wide enough to allow access of instruments.
  • Informed consent fulfilled.

Exclusion Criteria:

  • Signs of irreversible pulpitis or pulp necrosis.
  • Patients allergic to silver products.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silver Diamine Fluoride (SDF) group
Atraumatic restorative technique will be performed. Then the cavities will be dried with a gentle flow of compressed air. One drop of silver diamine fluoride (Advantage Arrest Silver Diamine Fluoride 38% - Bottle) will be dispensed into a dappen dish. A micro brush will be bent, dipped into SDF and dabbed on the side of the dappen dish to remove excess liquid before application. SDF will be applied directly to affected tooth surface and dried with gentle flow of compressed air for 1 minute. Excess SDF will be removed with cotton roll. Teeth will be restored with glass ionomer cement (GC Fuji IX).
Drug: Silver Diamine Fluoride
SDF will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)
Other Names:
  • SDF
Active Comparator: Chlorhexidine group
Atraumatic restorative treatment will be performed. Then, the cavities will be disinfected by placing a cotton pellet soaked in chlorhexidine solution (Consepsis®2% Chlorhexidine Antibacterial Solution) for 1 minute, air dried and restored using glass ionomer cement.
Drug: Chlorhexidine
Chlorhexidine will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)
Other Names:
  • CHG
Sham Comparator: Atraumatic Restorative Treatment without Disinfection
Cavities will be cleaned according to the ART approach.The cavity will be enlarged if needed using sterile hatchet.The carious dentin will be removed with excavators starting at the enamel-dentine junction. The unsupported thin enamel will be fractured off with the hatchet. The caries will be removed carefully until firm dentin is reached (physically resistant to hand excavation). The cavity will be cleaned with wet cotton pellets. Cavities will be restored immediately using conventional glass ionomer cement. All the cavities in the 3 groups will be temporary restored with glass ionomer cement handled according to manufacturer's instructions, however acid etching will not be carried out in order to make sample collection easier following the experimental period.
Procedure: Atraumatic Restorative Treatment without Disinfection
Atraumatic Restorative Technique will be performed without cavity disinfection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological assessment of total viable bacterial count
Time Frame: First day (baseline)
The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity. Two microliters of the samples collected will be inoculated on blood agar for total viable count.
First day (baseline)
Microbiological assessment of streptococcus mutans count
Time Frame: First day (baseline)
The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity. Two µl of the samples will be inoculated on mitis salivarius agar supplemented with 15 percent sucrose and bacitracin (0.2 U/ml) for selective isolation of Streptococcus mutans.
First day (baseline)
Microbiological assessment of lactobacilli count
Time Frame: First day (baseline)
The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity.Two µl of the samples will be inoculated on Rogosa agar, a medium selective for Lactobacilli.
First day (baseline)
Change in the total viable count.
Time Frame: 14 days
A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.
14 days
Change in the lactobacilli count.
Time Frame: 14 days
A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.
14 days
Change in the streptococcus mutans count.
Time Frame: 14 days
A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical changes in the dentin color
Time Frame: 14 days
Restoration will be removed and the dentin will be checked using visual-tactile method of examination.
14 days
Clinical changes in the dentin consistency
Time Frame: 14 days
Restoration will be removed and the dentin will be checked using visual-tactile method of examination.
14 days

Collaborators and Investigators

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

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

Investigators

  • Principal Investigator: Lina A Matar, BDS, Alexandria University
  • Study Director: Dina AE Kholeif, PhD, Faculty of Medicine, Alexandria Univerity

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

Helpful Links

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 (Actual)

January 12, 2018

Primary Completion (Actual)

January 18, 2019

Study Completion (Actual)

March 20, 2019

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDF as cavity disinfectant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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