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

Nourhan M.Aly60 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dental Caries

Interventions

Silver Diamine FluorideDRUG

SDF will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)

ChlorhexidineDRUG

Chlorhexidine will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)

Atraumatic Restorative Treatment without DisinfectionPROCEDURE

Atraumatic Restorative Technique will be performed without cavity disinfection

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

Microbiological assessment of total viable bacterial count

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.

Time frame: First day (baseline)

Microbiological assessment of streptococcus mutans count

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.

Time frame: First day (baseline)

Microbiological assessment of lactobacilli count

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.

Time frame: First day (baseline)

Change in the total viable count.

A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.

Time frame: 14 days

Change in the lactobacilli count.

A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.

Time frame: 14 days

Change in the streptococcus mutans count.

A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.

Time frame: 14 days

Secondary Outcomes

Data from ClinicalTrials.gov

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