Status:
RECRUITING
Remineralizing Effect of Different Silver-containing Agents on Initial Caries Lesions in Primary Teeth in Children
Lead Sponsor:
Plovdiv Medical University
Conditions:
White Spot Lesion of Tooth
Eligibility:
All Genders
3-8 years
Phase:
EARLY_PHASE1
Brief Summary
The aim of the present work is to study the effect of the application of Silver diamine fluoride (SDF) and a novel green synthesized Nano-silver fluoride (NSF) on early enamel lesions in primary teeth...
Detailed Description
Dental caries is a major public health concern, especially in very young children. Early detection of the disease enhances and simplifies treatment effectiveness. Non-operative treatments are particul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06489093
Start Date
July 29 2024
End Date
June 1 2025
Last Update
July 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University-Plovdiv
Plovdiv, Bulgaria, 4000