NCT06986551

Brief Summary

To evaluate the remineralization potential of PRG Barrier Coat versus fluoride varnish in white spot lesions in permanent anterior teeth of children.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress58%
Sep 2025Nov 2026

First Submitted

Initial submission to the registry

May 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 15, 2025

Last Update Submit

May 22, 2025

Conditions

White Spot Lesion of ToothDemineralization

Keywords

PRG Barrier Coatwhite spot lesionFluoride Varnish

Outcome Measures

Primary Outcomes (1)

  • Remineralization potential ΔE: will be recorded by the differences in color perception by Spectrophotometer

    The name of measurement: CIELAB parameters, which will record the difference in color perception. The CIELAB, or CIE L\* a\* b\*, color system represents quantitative relationship of colors on three axes. The measurement tool: spectrophotometer. (L\*a\*b\* values) L\*: denoted the tooth lightness. 1. : indicated hues change across the red-green axis. 2. : represents hues difference across the yellow-blue axis.

    1-3-6 months

Secondary Outcomes (1)

  • ΔE 2000 will be recorded by Spectrophotometer

    1-3-6 months

Study Arms (2)

PRG Barrier coat

EXPERIMENTAL

Before the application of the varnish, teeth were cleaned using a prophylaxis polishing past with a low-speed cone brush in a contra-angle low-speed handpiece. It was then dried with air and isolated using cotton rolls According to the manufacturer's instructions, for the application of PRG barrier coat varnish, a drop of the active will be mixed with the base using the attached brush. After isolation with cotton rolls, the brush will be used to smear the WSLs with the mix. I will be undisturbed for at least three seconds, then cured for 10 seconds using the visible-light curing unit. And there will be no postoperative instruction to the patient after application (light-cured resin material).

Other: PRG Barrier coat

5% NaF fluoride varnish

ACTIVE COMPARATOR

Before the application of the varnish, teeth were cleaned using a prophylaxis polishing past with a low-speed cone brush in a contra angle low-speed handpiece. It will be dried with air and isolated using cotton rolls. Package will be unpacked, and the application guide will be used to display the contents and mix to avoid the separation of sodium fluoride components. After isolation, a thin layer of the varnish will coat . The participants will be asked to keep their mouths closed to allow the varnish to set in the presence of saliva. Rinsing or suction was not allowed immediately after the application of the varnish. The participants will be asked to avoid consumption of rough and viscid food or hot drinks for two hours after application of the varnish. For the rest of that day, participants will be asked to eat soft food and stop tooth brushing (Ezzeldin et al., 2024

Other: 5% NaF fluoride varnish

Interventions

5% NaF fluoride varnishOTHER

Before the application of the varnish, teeth were cleaned using a prophylaxis polishing past with a low-speed cone brush in a contra angle low-speed handpiece. It will be dried with air and isolated using cotton rolls. Package will be unpacked, and the application guide will be used to display the contents and mix to avoid the separation of sodium fluoride components. After isolation, a thin layer of the varnish will coat . The participants will be asked to keep their mouths closed to allow the varnish to set in the presence of saliva. Rinsing or suction was not allowed immediately after the application of the varnish. The participants will be asked to avoid consumption of rough and viscid food or hot drinks for two hours after application of the varnish. For the rest of that day, participants will be asked to eat soft food and stop tooth brushing (Ezzeldin et al., 2024).

5% NaF fluoride varnish
PRG Barrier coatOTHER

Before the application of the varnish, teeth were cleaned using a prophylaxis polishing past with a low-speed cone brush in a contra angle low-speed handpiece. It was then dried with air and isolated using cotton rolls. \| P a g e 13 According to the manufacturer's instructions, the application of PRG barrier coat varnish a drop of the active will be mixed with the base using the attached brush. After isolation with cotton rolls, the brush will be used to smear the WSLs with the mix. I will be undisturbed for at least three seconds, then cured for 10 seconds using the visible-light curing unit (Ezzeldin etal.,2024). And there will be no post operative instruction to patient after application (light cured resin material).

PRG Barrier coat

Eligibility Criteria

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

You may qualify if:

  • Children aged 8-14 years with good health according to the American Society of Anesthesiologists (ASA-I).
  • Have at least one white spot lesion with International Caries Detection and Assessment System (ICDAS II) score one or two
  • Has not used any remineralizing agent in the former three months.
  • Parents who accept to sign informed consent.
  • Cooperative patients

You may not qualify if:

  • Patients have caries or restorations in the labial surface.
  • Extrinsic or intrinsic stains.
  • patients under active orthodontic treatment.
  • Uncooperative patient.
  • Parents refuse to sign informed consent.
  • Medically unfit (other than ASAI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Related Publications (4)

  • Ezzeldin, N., Wahied, D. M., Atef, R., & Mustafa, S. (2024). Clinical evaluation of PRG Barrier coat versus fluoride varnish on the color improvement of white spot lesions in permanent teeth of children: A randomized controlled trial. MSA Dental Journal. https://msadj.journals.ekb.eg/

    BACKGROUND

  • Arifa MK, Ephraim R, Rajamani T. Recent Advances in Dental Hard Tissue Remineralization: A Review of Literature. Int J Clin Pediatr Dent. 2019 Mar-Apr;12(2):139-144. doi: 10.5005/jp-journals-10005-1603.

    PMID: 31571787BACKGROUND

  • Amaechi BT, van Loveren C. Fluorides and non-fluoride remineralization systems. Monogr Oral Sci. 2013;23:15-26. doi: 10.1159/000350458. Epub 2013 Jun 28.

    PMID: 23817057BACKGROUND

  • Okamoto M, Ali M, Komichi S, Watanabe M, Huang H, Ito Y, Miura J, Hirose Y, Mizuhira M, Takahashi Y, Okuzaki D, Kawabata S, Imazato S, Hayashi M. Surface Pre-Reacted Glass Filler Contributes to Tertiary Dentin Formation through a Mechanism Different Than That of Hydraulic Calcium-Silicate Cement. J Clin Med. 2019 Sep 11;8(9):1440. doi: 10.3390/jcm8091440.

    PMID: 31514356BACKGROUND

MeSH Terms

Interventions

PRG Barrier Coat

Study Officials

  • Hala M. Abbas, PhD

    Head of Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Hanaa H.M.F.M. Rady, Master's student

CONTACT

+201006257884Hanaa.hamdy@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The blinding of the operator is not possible due to the nature of the material used. Trial participants, outcome assessors and statisticians will be blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A random sequence will be generated by the assistant supervisor using the online form Using four-folded numbered paper on which remineralizing agent will be written contained in the closed white envelope When a patient agrees to participate in the trial, an envelope will be drawn by co-supervisor and name, telephone number and patient's I.D. will be written on it. Those selected envelopes will be opened at the treatment visit after taking baseline clinical data to choose which material should be used. Randomization and allocation concealment will be performed by the co-supervisor to avoid selection bias
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist

Study Record Dates

First Submitted

May 15, 2025

First Posted

May 23, 2025

Study Start

September 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)