Effect of Silver Agents on Early Tooth Decay in Children
Evaluation of the Effect of Green Synthesized Nano-silver Fluoride and Silver Diamine Fluoride on Carious Lesions in Children
This study tests if two types of silver treatments can help fix early tooth decay in kids aged 3 to 8 years.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Plovdiv Medical University Academic / other |
| Locations | 1 site (Plovdiv) |
| Trial ID | NCT06489093 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Silver diamine fluoride (SDF) and a newly developed Nano-silver fluoride (NSF) in treating early enamel lesions in primary teeth of children aged 3 to 8 years. It is a randomized controlled trial where participants will be assigned to one of three groups: NSF, SDF combined with potassium iodide, or a control group. The lesions will be assessed using established criteria to determine the efficacy of these treatments in remineralizing early carious lesions. The goal is to provide a non-invasive treatment option that enhances dental care for young children.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children aged 3 to 8 years with early enamel lesions on their primary teeth.
Not a fit: Patients with conditions that affect salivation or those taking medications that suppress salivary flow may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved non-invasive treatments for early tooth decay in children, reducing the need for more invasive procedures.
How similar studies have performed: Previous studies have shown promising results with similar fluoride treatments for early carious lesions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 3 - 8 years * Signed informed consent from parents to participate in the study. Verbal consent from the child for the upcoming manipulations. * Enrolled patients do not have any common diseases or conditions associated with decreased salivation and are not taking medications that suppress salivary flow. Study participants have no cognitive or behavioral impairment. The absence of disease will be confirmed by a history-taking interview with the parent. * Presence of incipient carious lesions (white spots) reaching the enamel interior, assessed with ICDAS system values 01 (first visible enamel change) and 02 (localized visible enamel change) and laser fluorescence values up to 20. The diagnostic threshold of the included lesions is defined as D1 A (active enamel lesion visible after drying) or D2 A (active enamel lesion visible without drying). Criteria for active lesions: under plaque, loss of gloss, loss of smoothness, diffuse borders of the lesion, opaque appearance, white colour, at pre-selection sites (in the cervical third of the enamel). The lesions are located on tooth surfaces with no preceding obturations. * Study participants had not performed remineralization or topical fluoride therapy on the included lesions within six months prior to study inclusion. * Children with no history of allergy to the medications administered. Exclusion Criteria: * Children who are considered medically compromised or medically complex patients. The presence of a medical condition is confirmed by a history interview with the child's parent or guardian and involves common diseases or conditions associated with decreased salivation and intake of medications that suppress salivary flow, cognitive and behavioral disorders. * Patients who underwent remineralizing or topical fluoride therapy to the included lesions in the last six months prior to study inclusion. * Patients with a history of allergy to the administered medication.
Where this trial is running
Plovdiv
- Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University-Plovdiv — Plovdiv, Bulgaria (Recruiting)
Study contacts
- Principal investigator: Antonia Palankalieva, DMD — Department Of Pediatric Dentistry, Faculty Of Dental Medicine, Medical University Of Plovdiv, Bulgaria
- Study coordinator: Antonia Palankalieva, DMD
- Email: antonia.palankalieva@mu-plovdiv.bg
- Phone: +359889205904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.