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Trials / Completed

CompletedNCT04887389

Cariostatic and Remineralizing Effects of Three Different Dental Varnishes

Cariostatic and Remineralizing Effects of Three Different Dental Varnishes (A Clinical Trial)

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
115 (actual)
Sponsor
Nisreen Ibrahim khan · Academic / Other
Sex
All
Age
7 Years – 10 Years
Healthy volunteers
Accepted

Summary

This study is a randomly, controlled, prospective in vivo study. The objective of this study is: To evaluate the cariostatic and re-mineralizing effects of Nano silver fluoride, Nano Hydroxyapatite and sodium fluoride varnishes in caries prevention through: 1. Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria) 2. Calcium and fluoride content using enamel biopsy

Detailed description

Dental caries is a chronic, multi factorial, transmissible, infectious disease. Caries prevalence in young children in Egypt is very high, and most of the decayed teeth are left untreated, The increase prevalence of dental caries in children globally and in developing countries such as Egypt particularly makes the need for preventive treatment is necessary, one of the ways to prevent dental caries is the application of fluoride which can prevent dental caries by inhibiting demineralization of the crystal structures inside the tooth and enhancing remineralization. Subsequently over the years various topical fluoride agents have been evolved but NaF (a 22,600 ppm F- preparation) is the most commonly used agent, Based on systematic studies, 5% NaF varnish was more effective in re-mineralizing early enamel caries. Another anti caries product is a nano-hydroxyapatite (n-HAP), it has antibacterial effect, higher solubility, surface energy and bio activity, there are several studies concluded that 10% (n-HAP) may be optimal for remineralization of early enamel caries Nano-Silver Fluoride (NSF) is a new experimental formulation containing silver nanoparticles, it was introduced by Targino AG et al.(2014) to combat the problem of black discoloration of Silver Diamine Fluoride. It is safe to be used in humans and has effective antimicrobial properties against the pathogens responsible for the development of dental caries. most of the studies have been evaluated the effectiveness of anti-caries agent in In Vitro and to the best of our knowledge, there are no published studies in Egypt on the effectiveness of these agent. As such, due to the continuous development of new remineralizing agents, research is needed to investigate the newer remineralizing agents under different circumstances. The present study will be carried out to evaluate the efficacy of Nano silver fluoride, Nano Hydroxyapatite and Sodium fluoride varnishes in caries prevention.

Conditions

Interventions

TypeNameDescription
DRUGNano Silver Fluoride varnishNano Silver Fluoride(5%) is a new experimental formulation containing silver nanoparticles, chitosan and fluoride combines preventive and antimicrobial properties. It is a yellow solution and safe to be used in humans
DRUGnano-hydroxyapatite varnishnano-hydroxyapatite (10%) has antibacterial effect, higher solubility, surface energy and bioactivity and its structure is similar to dental apatite.
DRUGsodium Fluoride VarnishFluoride varnish (5%) applied every six months is effective in preventing caries in the primary and permanent dentition of children and adolescents

Timeline

Start date
2021-08-01
Primary completion
2022-09-01
Completion
2023-02-01
First posted
2021-05-14
Last updated
2024-04-02

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04887389. Inclusion in this directory is not an endorsement.