Back to resultsThe Antibacterial Effect of Nanosilver Fluoride on Primary Teeth
Primary Purpose
Primary Teeth, Microbial Colonization, Caries
Status
Terminated
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Nanosilver Fluoride (NSF)
Silver diamine fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Primary Teeth focused on measuring Nano silver fluoride, silver diamine fluoride, antibacterial, caries arrest, microbiology, primary teeth, pediatric, clinical trial, nanosilver, SDF
Eligibility Criteria
Inclusion Criteria:
- The presence of at least one active carious lesion on a primary tooth.
- Completion of an informed consent to participate in the study.
Exclusion criteria:
- Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling, abscess, obvious discoloration of the tooth, or premature mobility.
- Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes within the last 2 weeks.
- Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow.
- Allergy or sensitivity to silver or any of the materials included in the study.
- Child weight less than 10 Kg (to avoid concerns for toxicity).
Sites / Locations
- Faculty of Dentistry, Alexandria Univeristy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Silver diamine fluoride
Nanosilver fluoride
Arm Description
These active caries lesions will receive silver diamine fluoride treatment
These active caries lesions will receive nanosilver fluoride treatment
Outcomes
Primary Outcome Measures
Antibacterial Effect in Active Dental Caries Lesions
Measuring the percent change in prevalence of cariogenic bacteria using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected immediately before application of the intervention (baseline) and one month after the intervention application (1 month follow-up).
The CFU counts will be used to calculate the percentage change in bacterial prevalence which will be used for assessment and reporting results
The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions
A statistical analysis will be done to correlate between the change in number of available cariogenic bacteria from baseline to 1 month (measured in colony forming units) and the caries activity of the lesion (as specified by the international caries detection and assessment system (ICDAS II) criteria.
Antibacterial Effect in Unstimulated Saliva Samples
Measuring the change in prevalence of cariogenic bacteria using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.
Secondary Outcome Measures
The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions
A statistical analysis will be done to correlate between the change in number of available cariogenic bacteria from baseline to 3 months (measured in colony forming units) and the caries activity of the lesion (as specified by the international caries detection and assessment system (ICDAS II) criteria.
Antibacterial Effect in Active Dental Caries Lesions
Measuring the change in prevalence of cariogenic bacteria from baseline to 3 months using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.
Antibacterial Effect in Unstimulated Saliva Samples
Measuring the change in prevalence of cariogenic bacteria from baseline to 3 months using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05221749
Brief Title
The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth
Official Title
The Antibacterial Effect of Nanosilver Fluoride in Relation to Caries Activity in Primary Teeth: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Only the 1 month follow-up was completed. The principal investigator could not complete the 3 month follow-up appointments and was not calibrated with other dentists who were available at the time.
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nour Ammar, BDS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess the antibacterial effect of Nanosilver Fluoride (NSF) in relation to caries activity in dentin caries lesions of primary teeth in comparison to Silver Diamine Fluoride (SDF).
Detailed Description
Fifty children aged 4 to 6 years old with active dentin caries lesions (score 5 according to International Detection and Assessment System (ICDAS II) criteria) will be enrolled in the study. They will be equally and randomly allocated into 2 groups: a group receiving NSF and a control group receiving SDF treatment. Microbiological samples will be collected from the carious lesions and from unstimulated saliva at the baseline and at the 1 and 3 months' follow-up appointments. Bacterial counts will be assessed using Mitis Salivarius agar (selective culture media for S. mutans) and Rogosa agar (selective culture media for lactobacilli), and the results will be expressed in colony-forming units. Data regarding the children's oral health will be collected and their dmf index will be scored. The arrest of active carious lesions will be measured at the follow-up appointments according to ICDAS II criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Teeth, Microbial Colonization, Caries, Dental Caries in Children
Keywords
Nano silver fluoride, silver diamine fluoride, antibacterial, caries arrest, microbiology, primary teeth, pediatric, clinical trial, nanosilver, SDF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silver diamine fluoride
Arm Type
Active Comparator
Arm Description
These active caries lesions will receive silver diamine fluoride treatment
Arm Title
Nanosilver fluoride
Arm Type
Experimental
Arm Description
These active caries lesions will receive nanosilver fluoride treatment
Intervention Type
Drug
Intervention Name(s)
Nanosilver Fluoride (NSF)
Other Intervention Name(s)
Nanosilver Fluoride
Intervention Description
Optimized synthesis of Nanosilver Fluoride
Intervention Type
Drug
Intervention Name(s)
Silver diamine fluoride
Other Intervention Name(s)
Advantage Arrest by Elevate Oral care, 38% SDF
Intervention Description
Silver Diamine Fluoride
Primary Outcome Measure Information:
Title
Antibacterial Effect in Active Dental Caries Lesions
Description
Measuring the percent change in prevalence of cariogenic bacteria using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected immediately before application of the intervention (baseline) and one month after the intervention application (1 month follow-up).
The CFU counts will be used to calculate the percentage change in bacterial prevalence which will be used for assessment and reporting results
Time Frame
1 month
Title
The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions
Description
A statistical analysis will be done to correlate between the change in number of available cariogenic bacteria from baseline to 1 month (measured in colony forming units) and the caries activity of the lesion (as specified by the international caries detection and assessment system (ICDAS II) criteria.
Time Frame
1 month
Title
Antibacterial Effect in Unstimulated Saliva Samples
Description
Measuring the change in prevalence of cariogenic bacteria using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.
Time Frame
1 months
Secondary Outcome Measure Information:
Title
The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions
Description
A statistical analysis will be done to correlate between the change in number of available cariogenic bacteria from baseline to 3 months (measured in colony forming units) and the caries activity of the lesion (as specified by the international caries detection and assessment system (ICDAS II) criteria.
Time Frame
3 month
Title
Antibacterial Effect in Active Dental Caries Lesions
Description
Measuring the change in prevalence of cariogenic bacteria from baseline to 3 months using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.
Time Frame
3 month
Title
Antibacterial Effect in Unstimulated Saliva Samples
Description
Measuring the change in prevalence of cariogenic bacteria from baseline to 3 months using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The presence of at least one active carious lesion on a primary tooth.
Completion of an informed consent to participate in the study.
Exclusion criteria:
Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling, abscess, obvious discoloration of the tooth, or premature mobility.
Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes within the last 2 weeks.
Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow.
Allergy or sensitivity to silver or any of the materials included in the study.
Child weight less than 10 Kg (to avoid concerns for toxicity).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nour Ammar, BDS
Organizational Affiliation
Faculty of dentistry, Alexandria University, Alexandria, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria Univeristy
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Each participant will be provided with a serial number that will only be accessible to the principal investigator. No data regarding the identity of the participants will be shared under any circumstances. All participants or their guardians must provide a written informed consent prior to any procedures.
Citations:
PubMed Identifier
35804457
Citation
Ammar N, El-Tekeya MM, Essa S, Essawy MM, El Achy SN, Talaat DM. The antibacterial effect of nanosilver fluoride in relation to caries activity in primary teeth: a protocol for a randomized controlled clinical trial. Trials. 2022 Jul 8;23(1):558. doi: 10.1186/s13063-022-06477-5.
Results Reference
derived
Learn more about this trial
The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth
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