Remineralizing Effect of Different Silver-containing Agents on Initial Caries Lesions in Primary Teeth in Children
NCT Number: NCT06489093
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: White Spot Lesion of Tooth
Interventions: DRUG: NSF|DRUG: SDF+KI|OTHER: Control group
Sponsor: Plovdiv Medical University
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2025-06
Locations: Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University-Plovdiv, Plovdiv, 4000, Bulgaria

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. Proving their positive effect would be the basis for the development of innovative dental materials and hygienic agents to combat the carious process, which is a critical prerequisite for improving the quality of dental services and reducing dental anxiety and fear.

Primary Outcome Measures: Visual assessment using ICDAS II coding system, Code 0: Sound tooth surface Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel visible when wet, lesion must be visible when dry.

Code 3: Localized enamel breakdown because of caries with no visible dentin or underlying shadow.

Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown.

Code 5: Distinct cavity with visible dentin. Code 6: Extensive distinct cavity with visible dentin.

After treatment, the evaluation will be performed as follows: Increase to ICDAS 3 or more indicates caries progression; decrease to 0-1 this indicates caries regression. If score remains the same this indicates no change in lesion.

No. of lesions with scores 0,1,2,3 or more will be assessed and analyzed., 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)|Activity of a carious lesion using Nyvad Caries Diagnostic Criteria, Code 0: Sound (normal) enamel Code 1: Active caries (intact surface) - Surface of enamel is whitish/yellowish opaque Code 2: Active caries (surface discontinuity) Code 3: Active caries (cavity) - Enamel/dentin cavity easily visible with the naked eye.

Code 4: Inactive caries (intact surface) - Surface of enamel is whitish, brownish or black.

Code 5: Inactive caries (surface discontinuity) - Same criteria as score 4. Localized surface defect (microcavity) in enamel only Code 6: Inactive caries (cavity) - Enamel/dentin cavity easily visible with the naked eye; surface of cavity may be shiny and feels hard on probing with gentle pressure.

Code 7: Filling (sound surface) Code 8: Filling + active caries - Caries lesion may be cavitated or noncavitated.

Code 9: Filling + inactive caries - Caries lesion may be cavitated or noncavitated., 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)|Change in lesion fluorescence evaluated using diode laser fluorescence device, Laser fluorescence values are categorized using the following scale:

0-5 - no change 5-10 - enamel caries located in the outer enamel surface 10-15 - enamel caries located to the middle of the enamel 15-20 - enamel caries reaching the dentine enamel junction \>20 - caries in the dentine, 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)