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

NCT05941429 | Active Not Recruiting Phase 1

• 1 other identifier: 14422021493714
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• ICDAS II

  baseline

• ICDAS II

  3 weeks

• ICDAS II

  6 months

Study Arms (2)

Silver Diamine Fluoride

ACTIVE COMPARATOR

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

Drug: Silver diamine fluoride

Nano-Silver Fluoride

EXPERIMENTAL

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

Drug: Nano-Silver Fluoride

Interventions

Nano-Silver Fluoride 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 .

Also known as: NSF

Nano-Silver Fluoride

Silver diamine fluoride DRUG

38% silver diamine fluoride

Also known as: SDF

Silver Diamine Fluoride

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Giza, Egypt

Location

MeSH Terms

Interventions

silver diamine fluoride

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded study. Participants were blinded towards agents used in the study by using two identical squeezable plastic droppers with tag codes A and B. Also the bio-statistician will be blinded from the meaning of codes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric dentist

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 12, 2023
• Study Start: February 7, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

EG (1)