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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Silver Diamine Fluoride

Chlorhexidine

Atraumatic Restorative Treatment without Disinfection

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Atraumatic Restorative Treatment, Chlorhexidine, Silver Diamine Fluoride, Primary Teeth

Eligibility Criteria

4 Years - 6 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Silver Diamine Fluoride (SDF) group

Chlorhexidine group

Atraumatic Restorative Treatment without Disinfection

Arm 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).

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Change in the lactobacilli count.

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

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.

Secondary Outcome Measures

Clinical changes in the dentin color

Restoration will be removed and the dentin will be checked using visual-tactile method of examination.

Clinical changes in the dentin consistency

Restoration will be removed and the dentin will be checked using visual-tactile method of examination.

Full Information

NCT ID

NCT03855527

First Posted

February 22, 2019

Last Updated

April 8, 2020

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT03855527

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 12, 2018 (Actual)

Primary Completion Date

January 18, 2019 (Actual)

Study Completion Date

March 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Silver Diamine Fluoride (SDF) group

Arm Type

Experimental

Arm 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).

Arm Title

Chlorhexidine group

Arm Type

Active Comparator

Arm 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.

Arm Title

Atraumatic Restorative Treatment without Disinfection

Arm Type

Sham Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Silver Diamine Fluoride

Other Intervention Name(s)

SDF

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Chlorhexidine

Other Intervention Name(s)

CHG

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Atraumatic Restorative Treatment without Disinfection

Intervention Description

Atraumatic Restorative Technique will be performed without cavity disinfection

Primary Outcome Measure Information:

Title

Microbiological assessment of total viable bacterial count

Description

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)

Title

Microbiological assessment of streptococcus mutans count

Description

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)

Title

Microbiological assessment of lactobacilli count

Description

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)

Title

Change in the total viable count.

Description

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

Time Frame

14 days

Title

Change in the lactobacilli count.

Description

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

Time Frame

14 days

Title

Change in the streptococcus mutans count.

Description

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

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Clinical changes in the dentin color

Description

Restoration will be removed and the dentin will be checked using visual-tactile method of examination.

Time Frame

14 days

Title

Clinical changes in the dentin consistency

Description

Restoration will be removed and the dentin will be checked using visual-tactile method of examination.

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lina A Matar, BDS

Organizational Affiliation

Alexandria University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Karin ML Dowidar, PhD

Organizational Affiliation

Alexandria University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Dalia AM Talaat, PhD

Organizational Affiliation

Alexandria University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Dina AE Kholeif, PhD

Organizational Affiliation

Faculty of Medicine, Alexandria Univerity

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry, Alexandria University

City

Alexandria

ZIP/Postal Code

21512

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

29122072

Citation

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.

Results Reference

background

PubMed Identifier

26897901

Citation

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.

Results Reference

background

PubMed Identifier

27099357

Citation

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.

Results Reference

background

PubMed Identifier

12459616

Citation

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.

Results Reference

background

PubMed Identifier

9353579

Citation

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.

Results Reference

background

Links:

URL

http://vida.gt/clinica/doctores/wp-content/uploads/sites/2/2014/07/ART_Manual_English.pdf

Description

Manual for the atraumatic restorative treatment approach to control dental caries.

URL

http://www.aapd.org/media/policies_guidelines/g_sdf.pdf

Description

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

Dental Caries

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial