Clinical trial NCT05221749: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: 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
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Antibacterial Effect in Active Dental Caries Lesions
timeFrame: 1 month
measure: The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions
timeFrame: 1 month
measure: Antibacterial Effect in Unstimulated Saliva Samples
timeFrame: 1 months
Secondary outcomes:
measure: The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions
timeFrame: 3 month
measure: Antibacterial Effect in Active Dental Caries Lesions
timeFrame: 3 month
measure: Antibacterial Effect in Unstimulated Saliva Samples
timeFrame: 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria Univeristy
Study officials:
affiliation: Faculty of dentistry, Alexandria University, Alexandria, Egypt.
name: Nour Ammar, BDS
role: PRINCIPAL_INVESTIGATOR
References:
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.