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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Drug: Silver diamine fluoride; Drug: Nano-Silver Fluoride

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Silver Diamine Fluoride; 38% Silver Diamine Fluoride varnish; the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges.; No excavation will be done to the infected dentin tissue prior to the application of the agent.; Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls.; 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.; 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	Drug: Silver diamine fluoride; 38% silver diamine fluoride; Other Names: SDF
Experimental: Nano-Silver Fluoride; Nano-Silver fluoride varnish preparation; the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges.; No excavation will be done to the infected dentin tissue prior to the application of the agent.; Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls.; 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.; 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	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 .; Other Names: NSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 12, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 14422021493714

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No