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

Nourhan M.Aly

Status and phase: Completed; Phase 2

Conditions: Dental Caries

Treatments: Drug: Silver Diamine Fluoride; Drug: Chlorhexidine; Procedure: Atraumatic Restorative Treatment without Disinfection

Study type: Interventional

Funder types: Other

Identifiers

NCT03855527

SDF as cavity disinfectant

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Silver Diamine Fluoride (SDF) group

Experimental group

Description:

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).

Treatment:

Drug: Silver Diamine Fluoride

Chlorhexidine group

Active Comparator group

Description:

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.

Treatment:

Drug: Chlorhexidine

Atraumatic Restorative Treatment without Disinfection

Sham Comparator group

Description:

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.

Treatment:

Procedure: Atraumatic Restorative Treatment without Disinfection