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Completed

NCT Number: NCT03855527

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

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).

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Silver diamine fluoride

Drug

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

Other names: SDF

Chlorhexidine

Drug

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

Other names: CHG

Atraumatic Restorative Treatment without Disinfection

Procedure

Atraumatic Restorative Technique will be performed without cavity disinfection

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2019
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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