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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Silver Diamine Fluoride
* Drug: Chlorhexidine
* Procedure: Atraumatic Restorative Treatment without Disinfection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a three arm randomized controlled clinical trial, where children indicated for Atraumatic Restorative Treatment (ART) will be selected.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver Diamine Fluoride (SDF) group<br>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<br>* SDF will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)<br>* Other names: SDF;|
| Active Comparator: Chlorhexidine group<br>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<br>* Chlorhexidine will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)<br>* Other names: CHG;|
| Sham Comparator: Atraumatic Restorative Treatment without Disinfection<br>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<br>* Atraumatic Restorative Technique will be performed without cavity disinfection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 14 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atraumatic Restorative Treatment, Chlorhexidine, Silver Diamine Fluoride, Primary Teeth