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NCT Number: NCT05941429

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cairo university

Giza, Egypt

About this study

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:

  • Non-invasive treatment leading to reduce patient anxiety and stress.
  • No drilling and filling.
  • Protects against further caries progression.

Benefits for the practitioner:

  • Provide alternative treatment options.
  • Pain-free procedure that facilitates child management and saves time.

Benefits for the community:

  • Increasing overall oral health
  • Provides more information by testing new material
  • To provide better service quality.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

Other names: NSF

Silver diamine fluoride

Drug

38% silver diamine fluoride

Other names: SDF

Primary outcomes

  1. caries lesion activity and severity assessment using Nyvad criteria

    Time frame: baseline

    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 )

  2. caries lesion activity and severity assessment using Nyvad criteria

    Time frame: 3 weeks

    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. caries lesion activity and severity assessment using Nyvad criteria

    Time frame: 6 months

    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 )

Secondary outcomes

  1. ICDAS II

    Time frame: baseline

    Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )

  2. ICDAS II

    Time frame: 3 weeks

    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. ICDAS II

    Time frame: 6 months

    Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2023
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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