Actively Recruiting
Evaluation of the Effect of Green Synthesized Nano-silver Fluoride and Silver Diamine Fluoride on Carious Lesions in Children
Led by Plovdiv Medical University · Updated on 2024-07-05
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dental caries, especially in very young children, is a major public health concern. Early detection and non-operative treatments can simplify care, reduce the need for future procedures, and improve comfort and compliance. This research aims to compare the effects of Silver diamine fluoride (SDF) and a laboratory-prepared green synthesized Nano-silver fluoride (NSF) on early enamel lesions in primary teeth of children aged 3 to 8 years. Participants are randomly assigned to one of three groups: one receiving green synthesized Nano-silver fluoride, another treated with SDF combined with potassium iodide (SDF+KI), and a control group receiving no intervention except daily brushing with aminofluoride toothpaste and a provided toothbrush. Treatments are applied following specific protocols, including isolation of the working field and use of a gingival barrier. Follow-ups occur at 1, 3, 6, and 12 months after treatment. Throughout the study, lesion assessments use visual tools (ICDAS II coding and Nyvad criteria) and laser fluorescence at baseline and during follow-ups. Children receive professional oral hygiene before treatment, and oral hygiene instructions are provided after. The study measures changes in lesion appearance and activity over 12 months to evaluate the treatments' impact, aiming to support development of new dental materials and improve dental care quality for children.
CONDITIONS
Brief Title
Remineralizing Effect of Different Silver-containing Agents on Initial Caries Lesions in Primary Teeth in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 and 8 years
- Signed informed consent from parents and verbal consent from the child
- Healthy children without diseases or medications that reduce salivation
- Presence of early enamel caries lesions (white spots) assessed by ICDAS system values 01 or 02 and laser fluorescence up to 20
- Lesions located on tooth surfaces without previous restorations
- No remineralization or topical fluoride therapy on included lesions within past 6 months
- No history of allergy to the study medications
You will not qualify if you...
- Medically compromised or complex children with diseases or medications that reduce salivation, or cognitive and behavioral disorders
- Remineralizing or topical fluoride therapy to included lesions in last 6 months
- History of allergy to the administered medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single application at baseline
Participants receive treatment with one of three interventions: green synthesized Nano silver fluoride, silver diamine fluoride with potassium iodide, or standard oral hygiene instructions with fluoride toothpaste.
1 baseline visit (in-person)
Duration - 12 months
Participants return for follow-up visits to assess the effect of treatment on caries lesions using visual and fluorescence methods.
Visits at 1 month, 3 months, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University-Plovdiv
Plovdiv, Bulgaria, 4000
Actively Recruiting
Research Team
A
Antonia Palankalieva, DMD
A
Ani Belcheva, DMD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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