Dental CariesPhase 2NCT03855527

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

A Phase 2 study testing Silver Diamine Fluoride, Chlorhexidine and Atraumatic Restorative Treatment without Disinfection in people with Dental Caries, run by Nourhan M.Aly at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 4 to 6 years
Conditions the study is for: Dental Caries
What is being tested?: Silver Diamine Fluoride, Chlorhexidine and Atraumatic Restorative Treatment without Disinfection
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 12 Jan 2018to 20 Mar 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Alexandria University
Alexandria, 21512

Other trials in Egypt

About this study

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

Read the 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.

Conditions: Dental Caries
Being tested: Silver Diamine Fluoride, Chlorhexidine, Atraumatic Restorative Treatment without Disinfection
Keywords: Atraumatic Restorative Treatment, Chlorhexidine, Silver Diamine Fluoride, Primary Teeth
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Silver Diamine FluorideDrug
Also called SDF
SDF will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)
ChlorhexidineDrug
Also called CHG
Chlorhexidine will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)
Atraumatic Restorative Treatment without DisinfectionProcedure or surgery
Atraumatic Restorative Technique will be performed without cavity disinfection

Study groups in NCT03855527
Study group	Role	What they receive
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). Receives: 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. Receives: 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. Receives: Procedure: Atraumatic Restorative Treatment without Disinfection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days

Secondary outcomes (2)

Clinical changes in the dentin color
Restoration will be removed and the dentin will be checked using visual-tactile method of examination.
Measured: 14 days
Clinical changes in the dentin consistency
Restoration will be removed and the dentin will be checked using visual-tactile method of examination.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 201820 Mar 2019

First posted26 Feb 2019
Study start12 Jan 2018
Primary completion18 Jan 2019
Study completion20 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Dental CariesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03855527
Sponsor's protocol ID: SDF as cavity disinfectant
Status last verified: Apr 2020
First submitted: 22 Feb 2019
Last updated: 10 Apr 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 29122072
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.
PubMed 26897901
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.
PubMed 27099357
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.
PubMed 12459616
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.
PubMed 9353579

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03855527
Acronym / sponsor ID: SDF as cavity disinfectant
Conditions: Dental Caries
Keywords: Atraumatic Restorative Treatment, Chlorhexidine, Silver Diamine Fluoride, Primary Teeth
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Nourhan M.AlyUniversity, hospital or other
Collaborators: Alexandria University
Study start: 12 Jan 2018 (actual)
Primary completion: 18 Jan 2019 (actual)
Study completion: 20 Mar 2019 (actual)
First posted: 26 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3
Model description: This study is a three arm randomized controlled clinical trial, where children indicated for Atraumatic Restorative Treatment (ART) will be selected.

Arm	Type	Receives
Silver Diamine Fluoride (SDF) group	Experimental	Drug: Silver Diamine FluorideAtraumatic 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).
Chlorhexidine group	Active comparator	Drug: ChlorhexidineAtraumatic 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.
Atraumatic Restorative Treatment without Disinfection	Sham comparator	Procedure: Atraumatic Restorative Treatment without DisinfectionCavities 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.

Who may qualify

Ages: 4 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Silver Diamine FluorideAlso: SDFSDF will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)	Drug	Silver Diamine Fluoride (SDF) group
ChlorhexidineAlso: CHGChlorhexidine will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)	Drug	Chlorhexidine group
Atraumatic Restorative Treatment without DisinfectionAtraumatic Restorative Technique will be performed without cavity disinfection	Procedure or surgery	Atraumatic Restorative Treatment without Disinfection

Primary outcome

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.
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.
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.
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.
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.
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.

2 secondary outcomes

Clinical changes in the dentin color
Time frame: 14 days
Clinical changes in the dentin consistency
Time frame: 14 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
Background: PubMed 29122072Joshi 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.
Background: PubMed 26897901Horst 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.
Background: PubMed 27099357Innes 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.
Background: PubMed 12459616Massara 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.
Background: PubMed 9353579Bjorndal 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.
Manual for the atraumatic restorative treatment approach to control dental caries.Link provided by the sponsor.
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 dentistryLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lina A Matar, BDS principal investigator

Alexandria University

Karin ML Dowidar, PhD study director

Alexandria University

Dalia AM Talaat, PhD study director

Alexandria University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Silver Diamine Fluoride, Chlorhexidine and Atraumatic Restorative Treatment without Disinfection in people with Dental Caries, run by Nourhan M.Aly at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiological assessment of total viable bacterial count (time frame: First day (baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03855527, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.