Cariostatic and Remineralizing Effects of Three Different Dental Varnishes

Nisreen Ibrahim khan

Status and phase: Completed; Phase 4

Conditions: Fluoride Varnishes; Resistance, Dental Caries; Dental Caries in Children; Cariostatic Agent

Treatments: Drug: sodium Fluoride Varnish; Drug: nano-hydroxyapatite varnish; Drug: Nano Silver Fluoride varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT04887389

A07071020

Details and patient eligibility

About

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

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• The inclusion criteria of participated children :

  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.

     Exclusion Criteria:

  <!-- -->
  1. Teeth with score 3 or more according to ICDAS II index.
  2. Partially erupted permanent teeth.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 3 patient groups

Group of • Nano Silver Fluoride varnish ( NSF)

Experimental group

Description:

Selected children will be divided randomly into three groups: Group 1: Children receiving Nano Silver Fluoride varnish (NSF) (n =50).

Treatment:

Drug: Nano Silver Fluoride varnish

group of Nano hydroxyapatite varnish (n-HAP)

Experimental group

Description:

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

Treatment:

Drug: nano-hydroxyapatite varnish

group of Sodium Fluoride Varnish (NaF)

Experimental group

Description:

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

Treatment:

Drug: sodium Fluoride Varnish