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

NCT03855527 | Completed Phase 2

• 1 other identifier: SDF as cavity disinfectant
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dental Caries

Keywords

Atraumatic Restorative Treatment; Chlorhexidine; Silver Diamine Fluoride; Primary Teeth

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Clinical changes in the dentin color

  14 days

• Clinical changes in the dentin consistency

  14 days

Study Arms (3)

Silver Diamine Fluoride (SDF) group

EXPERIMENTAL

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

Chlorhexidine group

ACTIVE COMPARATOR

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

Atraumatic Restorative Treatment without Disinfection

SHAM COMPARATOR

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

Interventions

Silver Diamine Fluoride DRUG

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

Also known as: SDF

Silver Diamine Fluoride (SDF) group

Chlorhexidine DRUG

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

Also known as: CHG

Chlorhexidine group

Atraumatic Restorative Treatment without Disinfection PROCEDURE

Atraumatic Restorative Technique will be performed without cavity disinfection

Atraumatic Restorative Treatment without Disinfection

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (5)

• Joshi JS, Roshan NM, Sakeenabi B, Poornima P, Nagaveni NB, Subbareddy VV. Inhibition of Residual Cariogenic Bacteria in Atraumatic Restorative Treatment by Chlorhexidine: Disinfection or Incorporation. Pediatr Dent. 2017 Jul 15;39(4):308-312.

  PMID: 29122072 BACKGROUND

• Horst JA, Ellenikiotis H, Milgrom PL. UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications and Consent. J Calif Dent Assoc. 2016 Jan;44(1):16-28.

  PMID: 26897901 BACKGROUND

• Innes NP, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona A, Schwendicke F. Managing Carious Lesions: Consensus Recommendations on Terminology. Adv Dent Res. 2016 May;28(2):49-57. doi: 10.1177/0022034516639276.

  PMID: 27099357 BACKGROUND

• Massara ML, Alves JB, Brandao PR. Atraumatic restorative treatment: clinical, ultrastructural and chemical analysis. Caries Res. 2002 Nov-Dec;36(6):430-6. doi: 10.1159/000066534.

  PMID: 12459616 BACKGROUND

• Bjorndal L, Larsen T, Thylstrup A. A clinical and microbiological study of deep carious lesions during stepwise excavation using long treatment intervals. Caries Res. 1997;31(6):411-7. doi: 10.1159/000262431.

  PMID: 9353579 BACKGROUND

Related Links

• Manual for the atraumatic restorative treatment approach to control dental caries.
• Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. reference manual of American academy of pediatric dentistry

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride; Chlorhexidine; Disinfection

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sterilization; Infection Control; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Lina A Matar, BDS

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Karin ML Dowidar, PhD

  Alexandria University

  STUDY DIRECTOR

• Dalia AM Talaat, PhD

  Alexandria University

  STUDY DIRECTOR

• Dina AE Kholeif, PhD

  Faculty of Medicine, Alexandria Univerity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The operator will not be blinded to the type of treatment as each antibacterial agent has different consistency, color and application technique. However the expert assessing the microbiologic sample and statistician will be blinded to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Instructor and statistician

Model Details: This study is a three arm randomized controlled clinical trial, where children indicated for Atraumatic Restorative Treatment (ART) will be selected.

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 26, 2019
• Study Start: January 12, 2018
• Primary Completion: January 18, 2019
• Study Completion: March 20, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

EG (1)