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

NCT ID: NCT05941429

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-07
• Study Completion Date: 2024-12-31

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.

Conditions

Dental Caries in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Silver diamine fluoride

Intervention Type: DRUG

38% silver diamine 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

Group Type: EXPERIMENTAL

Nano-Silver Fluoride

Intervention Type: DRUG

NSF is a varnish which has been introduced as experimental formulation . the laboratory synthesis of NSF was carried out in a nano techonolgy center .

Interventions

Nano-Silver Fluoride

NSF is a varnish which has been introduced as experimental formulation . the laboratory synthesis of NSF was carried out in a nano techonolgy center .

Intervention Type: DRUG

Silver diamine fluoride

38% silver diamine fluoride

Intervention Type: DRUG

Other Intervention Names

NSF; SDF

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Lara Abdelmoniem Mohamed

Pediatric dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

14422021493714

Identifier Type: -

Identifier Source: org_study_id