Trial Outcomes & Findings for Antibacterial Effect of Nano Silver Fluoride vs Chlorhexidine on Occlusal Carious Molars Treated With Partial Caries Removal Technique (NCT NCT03186261)
NCT ID: NCT03186261
Last Updated: 2021-09-16
Results Overview
Digital Colony Counter, Agar Diffusion test
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
5 minutes on average between baseline and after application of the solution
Results posted on
2021-09-16
Participant Flow
Unit of analysis: Teeth
Participant milestones
| Measure |
Nano Silver Fluoride Solution
Nano silver fluoride solution (Prepared in Nanotech Co., Egypt) based on silver nanoparticles, chitosan and fluoride. Each tooth will receive two drops of NSF with a micro brush, equivalent to a dose of 10 mg of the solution.
Nano silver fluoride solution: Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties.
|
Cavity Cleanser
Chlorhexidine digluconate 2 % solution (Cavity Cleanser, Bisco, USA). Each tooth will receive two drops of cavity cleanser with a micro brush, equivalent to a dose of 10 mg of the solution.
Cavity Cleanser: Moistens dentin surface after cavity preparation using a micro brush.
|
|---|---|---|
|
Overall Study
STARTED
|
22 22
|
22 22
|
|
Overall Study
COMPLETED
|
22 22
|
22 22
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nano Silver Fluoride Solution
n=22 Participants
Nano silver fluoride solution (Prepared in Nanotech Co., Egypt) based on silver nanoparticles, chitosan and fluoride. Each tooth will receive two drops of NSF with a micro brush, equivalent to a dose of 10 mg of the solution.
Nano silver fluoride solution: Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties.
|
Cavity Cleanser
n=22 Participants
Chlorhexidine digluconate 2 % solution (Cavity Cleanser, Bisco, USA). Each tooth will receive two drops of cavity cleanser with a micro brush, equivalent to a dose of 10 mg of the solution.
Cavity Cleanser: Moistens dentin surface after cavity preparation using a micro brush.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
44 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=22 Participants
|
14 Participants
n=22 Participants
|
30 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=22 Participants
|
8 Participants
n=22 Participants
|
14 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Egypt
|
22 participants
n=22 Participants
|
22 participants
n=22 Participants
|
44 participants
n=44 Participants
|
|
Vital Permanent molar with deep occlusal carious lesion
|
22 Teeth
n=22 Participants
|
22 Teeth
n=22 Participants
|
44 Teeth
n=44 Participants
|
PRIMARY outcome
Timeframe: 5 minutes on average between baseline and after application of the solutionDigital Colony Counter, Agar Diffusion test
Outcome measures
| Measure |
Nano Silver Fluoride Solution
n=22 Participants
Nano silver fluoride solution (Prepared in Nanotech Co., Egypt) based on silver nanoparticles, chitosan and fluoride. Each tooth will receive two drops of NSF with a micro brush, equivalent to a dose of 10 mg of the solution.
Nano silver fluoride solution: Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties.
|
Cavity Cleanser
n=22 Participants
Chlorhexidine digluconate 2 % solution (Cavity Cleanser, Bisco, USA). Each tooth will receive two drops of cavity cleanser with a micro brush, equivalent to a dose of 10 mg of the solution.
Cavity Cleanser: Moistens dentin surface after cavity preparation using a micro brush.
|
|---|---|---|
|
Bacterial Count of Streptococus Mutans
Baseline
|
2.00 CFU/ml log10
Standard Deviation 0.33
|
2.04 CFU/ml log10
Standard Deviation 0.23
|
|
Bacterial Count of Streptococus Mutans
After solution application
|
1.12 CFU/ml log10
Standard Deviation 0.59
|
1.05 CFU/ml log10
Standard Deviation 0.63
|
Adverse Events
Nano Silver Fluoride Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cavity Cleanser
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ali Mostafa Shamaa
Faculty of Dentistry, Cairo University
Phone: +201005276468
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place