Cariostatic and Remineralizing Effects of Three Different Dental Varnishes

March 29, 2024 updated by: Nisreen Ibrahim khan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35511
        • Faculty of Dentistry / Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: 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
Other Names:
  • ( NSF)
Experimental: group of Nano hydroxyapatite varnish (n-HAP)
Group 2 Children receiving Nano-hydroxyapatite varnish (n = 50)
Drug: nano-hydroxyapatite varnish
nano-hydroxyapatite (10%) has antibacterial effect, higher solubility, surface energy and bioactivity and its structure is similar to dental apatite.
Other Names:
  • (n-HAP)
Experimental: group of Sodium Fluoride Varnish (NaF)
Group 3: Children receiving Sodium Fluoride Varnish (n = 50)
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
Other Names:
  • NaF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a. Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria
Time Frame: 1. All children will be assessed clinically in four visits along one year, at the baseline as well as at 3rd, 6th and 12th month of follow up visit

After taking the personal data of the participant, dental examination will be conducted by one trained and calibrated examiner under the standard situation including semi-supine position of the subject, good illumination and taking into account all methods of infection control.

Baseline dental examination for all surfaces of included teeth according to ICDAS II was recorded. Only the surfaces with 0, 1 and 2 score will be included in the follow up assessment (Drying of the tooth surface is the key for detecting non-cavitated lesions).

Diagnostic criteria for newly dental caries :

In order to compare the preventive efficacy of the three preventive agent, any change in the baseline recording of score 0, 1, or 2 will be recorded in each visit of all three groups, and an comparison will be made between the mean of tooth surfaces with score 0, 1 or 2 in the baseline visit and during all follow-up visits in each group and after that comparing among all groups.
1. All children will be assessed clinically in four visits along one year, at the baseline as well as at 3rd, 6th and 12th month of follow up visit
Enamel biopsy for detecting Calcium and Fluoride content .
Time Frame: Fluoride and calcium content will be evaluated at the baseline as well as at the last follow-up visit through study completion, an average of 1 year"
The tooth on which the biopsy had to be done will be isolated with the help of cotton rolls and high volume suction to eliminate any chances of saliva contamination. Sticking plaster will be used to cover the tooth to be subjected for biopsy. A 6 mm circular punch will be made in the sticking plaster keeping in mind that it should be present on the buccal surface of molar. A 6 mm non-fluoride containing circular blotting paper will wetted with 5 µL of 30% phosphoric acid and immediately placed on the punched window for 4 s . This filter paper will then transferred to plastic tube which had 0.1 ml of double distilled water pipetted using a micro-pipette. Equal amount of total ionic strength adjustment buffer (TISAB-II) will added using a micropipette to the plastic tube, after which it will be stored for 3 days. After that it will send to laboratory for fluoride and calcium analysis.At the end -fluoride varnish will be applied to the surface.
Fluoride and calcium content will be evaluated at the baseline as well as at the last follow-up visit through study completion, an average of 1 year"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nisreen Ibrahim khan

Investigators

  • Principal Investigator: Salwa A Hegazy, PhD, Head of Dental Public Health department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A07071020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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