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

NCT ID: NCT05775250

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-01-30

Brief Summary

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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

Detailed Description

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Conditions

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White Spot Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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giomer varnish

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

Group Type EXPERIMENTAL

giomer varnish

Intervention Type DRUG

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

fluoride varnish

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

Group Type ACTIVE_COMPARATOR

giomer varnish

Intervention Type DRUG

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

Interventions

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giomer varnish

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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October University for Modern Sciences and Arts

OTHER

Sponsor Role lead

Responsible Party

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Naglaa Ibrahim Ezz

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naglaa I Ezzeldin, Ass. Prof

Role: PRINCIPAL_INVESTIGATOR

October University for Modern Sciences and arts, Cairo, Egypt

Locations

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October University of Modern Sciences and Arts

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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REC-D 262-3

Identifier Type: -

Identifier Source: org_study_id

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