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

Cairo University (CU)

Status and phase: Active, not recruiting; Phase 1

Conditions: Dental Caries in Children

Treatments: Drug: Nano-Silver Fluoride; Drug: Silver diamine fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT05941429

14422021493714

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Silver Diamine Fluoride

Active Comparator group

Description:

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

Treatment:

Drug: Silver diamine fluoride

Nano-Silver Fluoride

Experimental group

Description:

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

Treatment:

Drug: Nano-Silver Fluoride