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

Primary Purpose

White Spot Lesion

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
giomer varnish
Sponsored by
October University for Modern Sciences and Arts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for White Spot Lesion focused on measuring white spot lesion, fluoride varnish, Giomer Varnish

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • October University of Modern Sciences and ArtsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

giomer varnish

fluoride varnish

Arm Description

Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once.

5% NaF fluoride varnish, it will be administrated once.

Outcomes

Primary Outcome Measures

white spot lesion color change
assessment of white spot lesion color by using spectrophotometer

Secondary Outcome Measures

Patient response to the treatment
Patient response to the treatment using facial image scale, scores from 1 to 5

Full Information

First Posted
March 7, 2023
Last Updated
March 17, 2023
Sponsor
October University for Modern Sciences and Arts
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1. Study Identification

Unique Protocol Identification Number
NCT05775250
Brief Title
Evaluation of Two Varnishes on the Improvement of White Spot Lesions in Children
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October University for Modern Sciences and Arts

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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 3 months and after 6 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesion
Keywords
white spot lesion, fluoride varnish, Giomer Varnish

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
giomer varnish
Arm Type
Experimental
Arm Description
Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once.
Arm Title
fluoride varnish
Arm Type
Active Comparator
Arm Description
5% NaF fluoride varnish, it will be administrated once.
Intervention Type
Drug
Intervention Name(s)
giomer varnish
Intervention Description
Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once.
Primary Outcome Measure Information:
Title
white spot lesion color change
Description
assessment of white spot lesion color by using spectrophotometer
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient response to the treatment
Description
Patient response to the treatment using facial image scale, scores from 1 to 5
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naglaa I Ezzeldin, ass. prof
Phone
+201001984184
Email
niezz@msa.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Dina M Wahid, lecturer
Phone
+201223365111
Email
dwahied@msa.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naglaa I Ezzeldin, Ass. Prof
Organizational Affiliation
October University for Modern Sciences and arts, Cairo, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
October University of Modern Sciences and Arts
City
Cairo
ZIP/Postal Code
3210001
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naglaa I Ezz El Din
Phone
00201001984184
Email
niezz@msa.eun.eg
First Name & Middle Initial & Last Name & Degree
Dina M Wahied
Phone
+201223365111
Email
dwahied@msa.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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