NCT06489093

Remineralizing Effect of Different Silver-containing Agents on Initial Caries Lesions in Primary Teeth in Children

Evaluation of the Effect of Green Synthesized Nano-silver Fluoride and Silver Diamine Fluoride on Carious Lesions in Children

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Plovdiv Medical University · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Accepted

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.

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 particularly advantageous as they are minimally invasive, reduce future operative treatment needs and are more comfortable, thereby improving overall compliance and dental experience. The aim of the study is to compare the clinical efficacy of Silver diamine fluoride (SDF) and laboratory prepared green synthesized Nano-silver fluoride on early enamel lesions in primary teeth. The proposed study is a randomized controlled clinical trial. Included patients are healthy positive children aged from 3 to 8 years, requiring non-operative treatment of incipient caries lesions on smooth surfaces of primary teeth. Lesions will be assessed visually using ICDAS II, Nyvad criteria and laser fluorescence (LF pen). Patients are randomly assigned to one of three study groups: Group N: Green synthesized Nano silver fluoride (prepared in laboratory) Group S: SDF + KI (38% Riva Star, SDI) Group C: Control group Prior to treatment parents are informed about the nature of the study and sign an informed consent. Children are introduced to the method of conducting treatment in a style appropriate for the child's age. Lesions are assesed using the ICDAS II system, Nyvad criteria and laser fluorescence. All patients receive professional oral hygiene with a fluoride-free brush and polishing paste. Treatment of each patient's respective teeth is performed following the treatment protocol of the respective agents. Follow-ups are performed at 1st, 3rd, 6th and 12th month.

Conditions

• White Spot Lesion of Tooth

Interventions

Type	Name	Description
DRUG	NSF	Prior to treatment the working field is isolated with cotton rolls. Gingival barrier is used for soft tissue protection. Application of NSF using a microapplicator on the carious lesion for 1 minute. Excess material and gingival barrier are removed. Participants receive oral hygiene instructions.
DRUG	SDF+KI	Prior to treatment the working field is isolated with cotton rolls. Gingival barrier is used for soft tissue protection. Application of 38% silver diamine fluoride (Riva star 38%, SDI) using a microapplicator on the carious lesion. Immediately afterwards, potassium iodide is applied as a reducing agent. Excess material and gingival barrier are removed. Participants receive oral hygiene instructions.
OTHER	Control group	Subjects will receive oral hygiene instructioins to apply fluoridated toothpaste to a toothbrush and brush teeth thoroughly for at least 2 minutes, then expectorate and rinse.

Timeline

• Start date: 2024-07-29
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2024-07-05
• Last updated: 2024-07-05

Locations

1 site across 1 country: Bulgaria