Evaluation of Two Varnishes on the Improvement of White Spot Lesions in Children

April 2, 2024 updated by: Naglaa Ibrahim Ezz, October University for Modern Sciences and Arts

Evaluation of Giomer Varnish Versus Fluoride Varnish on The Color Improvement of White Spot Lesions in Permanent Teeth of Children: A Randomized Controlled Clinical Trial

A randomized control trial evaluating the effect of the Giomer varnish versus fluoride varnish on the color improvement of the white spot lesion in permanent anterior teeth of children aged between 8-14 years by using a spectrophotometer at baseline, after 1 month, 3 months and 6 months

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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
      • Cairo, Egypt, 3210001
        • October University of Modern Sciences and Arts

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

8 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Patients with good general health.

    • Adequate oral hygiene,
    • Patients who didn't receive remineralizing agents during the last 3 months other than regular toothpaste.

Exclusion Criteria:

  • Uncooperative child.
  • Active carious lesion.
  • Labial surface restoration.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: giomer varnish
Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once.
Drug: giomer varnish
Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once.
Active Comparator: fluoride varnish
5% NaF fluoride varnish, it will be administrated once.
Drug: giomer varnish
Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
white spot lesion color change
Time Frame: 6 months
assessment of white spot lesion color by using spectrophotometer
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient response to the treatment
Time Frame: 6 months
Patient response to the treatment using facial image scale, scores from 1 to 5
6 months

Collaborators and Investigators

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

Sponsor

October University for Modern Sciences and Arts

Investigators

  • Principal Investigator: Naglaa I Ezzeldin, Ass. Prof, October University for Modern Sciences and arts, Cairo, Egypt

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)

March 15, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-D 262-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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