Cariostatic and Remineralizing Effects of Three Different Dental Varnishes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-02-01

Brief Summary

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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

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Detailed Description

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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

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Dental Caries in Children Cariostatic Agent Resistance, Dental Caries Fluoride Varnishes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Selected children will be divided randomly into three groups:

* Group 1: Children receiving Nano Silver Fluoride varnish (NSF) (n =39).
* Group 2 Children receiving Nano-hydroxyapatite varnish (n = 37).
* Group 3: Children receiving Sodium Fluoride Varnish (n = 39) Procedure for material application The application of single drop (0.1 mL) of either (5%) NSF, (10%) n-HAP, (5%) NaF varnishes with a disposable micro-applicator tip for 10 seconds. NSF will be used in a single application and no repetition. While n-HAP, NaF varnishes will be applied each 6 months .

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group of • Nano Silver Fluoride varnish ( NSF)

Selected children will be divided randomly into three groups:

Group 1: Children receiving Nano Silver Fluoride varnish (NSF) (n =50).

Group Type EXPERIMENTAL

Nano Silver Fluoride varnish

Intervention Type DRUG

Nano 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

group of Nano hydroxyapatite varnish (n-HAP)

Group 2 Children receiving Nano-hydroxyapatite varnish (n = 50)

Group Type EXPERIMENTAL

nano-hydroxyapatite varnish

Intervention Type DRUG

nano-hydroxyapatite (10%) has antibacterial effect, higher solubility, surface energy and bioactivity and its structure is similar to dental apatite.

group of Sodium Fluoride Varnish (NaF)

Group 3: Children receiving Sodium Fluoride Varnish (n = 50)

Group Type EXPERIMENTAL

sodium Fluoride Varnish

Intervention Type DRUG

Fluoride varnish (5%) applied every six months is effective in preventing caries in the primary and permanent dentition of children and adolescents

Interventions

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Nano Silver Fluoride varnish

Nano 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

Intervention Type DRUG

nano-hydroxyapatite varnish

nano-hydroxyapatite (10%) has antibacterial effect, higher solubility, surface energy and bioactivity and its structure is similar to dental apatite.

Intervention Type DRUG

sodium Fluoride Varnish

Fluoride varnish (5%) applied every six months is effective in preventing caries in the primary and permanent dentition of children and adolescents

Intervention Type DRUG

Other Intervention Names

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( NSF) (n-HAP) NaF

Eligibility Criteria

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Inclusion Criteria

1. Age rang 7-10 years.
2. Teeth with score 0, 1 or 2 according to (international caries detection and assessment system) ICDAS II index.
3. Patient did not receive any re-mineralizing agent other than the regular toothpaste during the past three months.
4. No known history of allergy against silver particles or colophonium.
5. written informed consent from the parents/guardians.