Trial Outcomes & Findings for The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth (NCT NCT05221749)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

50 participants

Primary outcome timeframe

1 month

Results posted on

2023-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Silver Diamine Fluoride (SDF) These active caries lesions will receive one application of 38% silver diamine fluoride at the baseline appointment.	Nanosilver Fluoride (NSF) These active caries lesions will receive one application of nanosilver fluoride at the baseline appointment.
Overall Study STARTED	25	25
Overall Study COMPLETED	23	22
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Silver Diamine Fluoride (SDF) These active caries lesions will receive one application of 38% silver diamine fluoride at the baseline appointment.	Nanosilver Fluoride (NSF) These active caries lesions will receive one application of nanosilver fluoride at the baseline appointment.
Overall Study Lost to Follow-up	2	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Silver Diamine Fluoride n=25 Participants These active caries lesions will receive silver diamine fluoride treatment Silver diamine fluoride: Silver Diamine Fluoride	Nanosilver Fluoride n=25 Participants These active caries lesions will receive nanosilver fluoride treatment Nanosilver Fluoride (NSF): Optimized synthesis of Nanosilver Fluoride	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Continuous	4.6 years STANDARD_DEVIATION 0.6 • n=25 Participants	4.9 years STANDARD_DEVIATION 0.9 • n=25 Participants	4.75 years STANDARD_DEVIATION 0.8 • n=50 Participants
Sex: Female, Male Female	11 Participants n=25 Participants	13 Participants n=25 Participants	24 Participants n=50 Participants
Sex: Female, Male Male	14 Participants n=25 Participants	12 Participants n=25 Participants	26 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants

PRIMARY outcome

Timeframe: 1 month

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