Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride

Phase 1

Active, not recruiting

• Conditions: Dental Caries in Children
• Interventions: Drug: Silver diamine fluoride; Drug: Nano-Silver Fluoride

• Registration Number: NCT05941429
• Lead Sponsor: Cairo University

Brief Summary

This study will be conducted to test the cariostatic effect of Nano Silver Fluoride in a comparison to Silver Diamine Fluoride in a group of preschool children.

Detailed Description

Silver Diamine Fluoride has offered a non-invasive and easily performed method to manage dental caries in very young children.Studies shows that SDF has been proven to arrest caries in cavitated lesions and to prevent caries in sound teeth as Fluoride is effective in enhancing the remineralization of dental hard tissue and silver ion acts as an antibacterial agent. However, It was found that silver causes staining to the dental tissues with a black discoloration, which can be considered to be a main drawback specifically, when it is used on anterior teeth. Nano-silver fluoride varnish preparation showed high efficacy in arresting caries progression in primary teeth without causing black discoloration to the tissues.Silver diamine fluoride (SDF) .

Benefits for patient:

1. Non-invasive treatment leading to reduce patient anxiety and stress.

2. No drilling and filling.

3. Protects against further caries progression.

Benefits for the practitioner:

1. Provide alternative treatment options.

2. Pain-free procedure that facilitates child management and saves time.

Benefits for the community:

1. Increasing overall oral health

2. Provides more information by testing new material

3. To provide better service quality.

Study Timeline

• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-12
• Study Start: 2024-02-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-12
• Last Update Posted: 2024-10-16
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Children aged from 3 to 5 years
• clinical diagnosis of active dentinal caries in primary teeth
• Co-operative participants and free of any systemic diseases

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Exclusion Criteria

• Children whose parents refuse to sign consent
• Primary teeth with pulp involvement, pain, mobility, abscess, sinus, fistula; or discoloration related to tooth non-vitality.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver Diamine Fluoride	Silver diamine fluoride	38% Silver Diamine Fluoride varnish 1. the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges. 2. No excavation will be done to the infected dentin tissue prior to the application of the agent. 3. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls. 4. After isolation, a single drop SDF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly. 5. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent
Nano-Silver Fluoride	Nano-Silver Fluoride	Nano-Silver fluoride varnish preparation 1. the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges. 2. No excavation will be done to the infected dentin tissue prior to the application of the agent. 3. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls. 4. After isolation, a single drop NSF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly. 5. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent

Primary Outcome Measures

Name	Time	Method
caries lesion activity and severity assessment using Nyvad criteria	6 months	visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )

Secondary Outcome Measures

Name	Time	Method
ICDAS II	6 months	Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Giza, Egypt