NCT05775250

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 1 month, 3 months and 6 months

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

March 7, 2023

Last Update Submit

April 2, 2024

Conditions

White Spot Lesion

Keywords

white spot lesionfluoride varnishGiomer Varnish

Outcome Measures

Primary Outcomes (1)

  • white spot lesion color change

    assessment of white spot lesion color by using spectrophotometer

    6 months

Secondary Outcomes (1)

  • Patient response to the treatment

    6 months

Study Arms (2)

giomer varnish

EXPERIMENTAL

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

Drug: giomer varnish

fluoride varnish

ACTIVE COMPARATOR

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

Drug: giomer varnish

Interventions

giomer varnishDRUG

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

fluoride varnishgiomer varnish

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October University of Modern Sciences and Arts

Cairo, 3210001, Egypt

Location

Study Officials

  • Naglaa I Ezzeldin, Ass. Prof

    October University for Modern Sciences and arts, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 20, 2023

Study Start

March 15, 2023

Primary Completion

October 30, 2023

Study Completion

January 30, 2024

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations

EG(1)