Trials / Terminated
TerminatedNCT05221749
The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth
The Antibacterial Effect of Nanosilver Fluoride in Relation to Caries Activity in Primary Teeth: a Randomized Controlled Clinical Trial
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Nour Ammar, BDS · Academic / Other
- Sex
- All
- Age
- 1 Year – 12 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nanosilver Fluoride (NSF) | Optimized synthesis of Nanosilver Fluoride |
| DRUG | Silver diamine fluoride | Silver Diamine Fluoride |
Timeline
- Start date
- 2022-03-15
- Primary completion
- 2022-04-15
- Completion
- 2022-06-15
- First posted
- 2022-02-03
- Last updated
- 2023-08-18
- Results posted
- 2023-08-18
Locations
1 site across 1 country: Egypt
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05221749. Inclusion in this directory is not an endorsement.