Caries Inhibitory Effect of Nano Silver and Tri Calcium Phosphate Varnishes Among Visually Impaired Children (Prevention)

August 28, 2024 updated by: Hadeer Mohammed Abd El wahab

Caries Inhibitory Effect of Nano Silver Varnish Versus Tri Calcium Phosphate Varnish Among Children With Visual Impairment

Assessment of pH,streptococcus mutants count, lactobacillus count and immunoglobulin A among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sixty children will be randomly divided into three equal treatment groups, composed of 20 children each, according to the type of material used as follows:

  • Group I: children will receive oral health education and nano silver fluoride varnish.
  • Group II: children will receive oral health education and tri calcium phosphate varnish.
  • Group III: children will receive oral health education

for all children ,Assessment of pH, streptococcus mutants count, lactobacillus count and immunoglobulin A will be assessed at baseline, one day , 3 months and 6 months after application

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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
    • Tanta City
      • Tanta, Tanta City, Egypt, 31527
        • Faculty of Dentistry

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Visually impaired children

Exclusion Criteria:

  • uncooperative children or children not willing to participate in the study.
  • Children with systemic diseases
  • Children with bronchial asthma.
  • Children who were on antibiotic or medications that might affect oral flora or salivary flow taken within the previous 3 months
  • History of fluoride treatment in the past 3-4 weeks.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nano silver varnish
new fluoride varnish
Drug: Nano silver fluoride varnish and tri calcium phosphate varnish
Fluoride varnishes
Other Names:
  • health education
Experimental: tri calcium phosphate varnish
fluoride varnish contain calcium phosphate
Drug: Nano silver fluoride varnish and tri calcium phosphate varnish
Fluoride varnishes
Other Names:
  • health education
No Intervention: health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary PH
Time Frame: 6 months
Salivary power of hydrogen at baseline, one month, 3months and six months after intervention
6 months
Salivary streptococcus mutants count
Time Frame: 6months
Count of bacteria at baseline, one day, 3months and six months after intervention
6months
Lactobacillus count
Time Frame: 6 months
Count of bacteria at baseline, one day, 3months and six months after intervention
6 months
Immunoglobulin A
Time Frame: 6months
Level of immunoglobulin A at saliva at baseline, one day, 3months and 6 months after intervention
6months

Collaborators and Investigators

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

Sponsor

Hadeer Mohammed Abd El wahab

Collaborators

Tanta University

Investigators

  • Study Director: Hatem Amin, PhD, Faculty of dentistry . Tanta university

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)

October 11, 2022

Primary Completion (Actual)

April 11, 2023

Study Completion (Actual)

April 13, 2023

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OH12-12

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

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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