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

Dental Caries in Children Clinical Trial

Official title:

Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride in a Group of Preschool Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05941429
• Other study ID #: 14422021493714
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2023
• Est. completion date: July 2024

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Drug:
• 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 .
• Silver diamine fluoride
38% silver diamine fluoride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caries lesion activity and severity assessment using Nyvad criteria	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 )	baseline
Primary	caries lesion activity and severity assessment using Nyvad criteria	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 )	3 weeks
Primary	caries lesion activity and severity assessment using Nyvad criteria	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 )	6 months
Secondary	ICDAS II	Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )	baseline
Secondary	ICDAS II	Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )	3 weeks
Secondary	ICDAS II	Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )	6 months