NCT05202821

Brief Summary

In-Vivo randomized clinical trial to compare between the clinical performance of fluoride varnish versus MI paste (CPP\_ACP) and the PRG- Barrier coat material concerning enamel remineralization, arrest of active early lesions, resolution of inactive incipient lesions and patient satisfaction and motivation with a 9-months follow up using a high resolution Nikon camera with Canon 700D body. Canon EF 100mm f2.8 USM Macro Lens and Nissin MF18 ring flash Canon fit for better illumination. Also, A set of retractors and A set child occlusal mirrors with A contraster for assessment of the remineralization progress of the white spot lesion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

March 1, 2021

Last Update Submit

January 17, 2022

Conditions

White Spot Lesions [Initial Caries] on Smooth Surface of Tooth

Keywords

White spot lesionsFluoride varnishMI paste (CPP_ACP)SPRG- Barrier coat

Outcome Measures

Primary Outcomes (1)

  • Change in the size of the white spot lesions using photographic assessment

    participants are divided into 3 groups. Each group receiving a different management approach to find out the most effective drug in reducing the size of white spot lesions. Photos are taken pre-operatively. 1 month, 3 months and 9 months

    9 months

Secondary Outcomes (1)

  • Remineralization of the enamel surface

    9 months

Other Outcomes (1)

  • Patient satisfaction and motivation towards treatment using a questionnaire at the end of the treatment

    9 months

Study Arms (3)

group of 20 participants receiving fluoride varnish

ACTIVE COMPARATOR

\*Group (I): patients will receive Fluoride varnish ttt.

Drug: Fluoride varnish

group of 20 participants receiving PR-G Barrier coat

EXPERIMENTAL

\*Group (II): patients will receive PR-G Barrier coat

Drug: PRG Barrier Coat

group of 20 participants receiving MI Paste (CPP-ACP)

ACTIVE COMPARATOR

\*Group (III): Patients will receive MI Paste (CPP-ACP)

Drug: MI paste

Interventions

PRG Barrier CoatDRUG

3 arm randomized single blind clinical trial comparing 3 groups. first group will be receiving fluoride varnish, second group will be receiving PRG Barrier Coat and the third group will be receiving MI paste

Also known as: SPRG Barrier Coat
group of 20 participants receiving PR-G Barrier coat
Fluoride varnishDRUG

First group will be receiving Fluoride varnish every 3 months

Also known as: Cavity Shield
group of 20 participants receiving fluoride varnish
MI pasteDRUG

Third group will be receiving MI paste

Also known as: RECALDENTâ„¢, (CPP-ACP)
group of 20 participants receiving MI Paste (CPP-ACP)

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 10-16 years old
  • Patient is healthy and medically free.
  • Moderate to high level of patient cooperation
  • Compliance of the primary caregiver
  • Moderate to high caries risk
  • Completed or in transitional fixed orthodontic treatment
  • At least 1 wsl should be present

You may not qualify if:

  • Poor oral hygiene
  • Deeply Cavitated white spot lesions
  • Medically Compromised patients.
  • Extremely Uncooperative patient or primary caregiver
  • Generalized white spot lesions in the mouth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Al Waili, 11566, Egypt

RECRUITING

MeSH Terms

Interventions

PRG Barrier Coatcavity shieldcasein phosphopeptide-amorphous calcium phosphate nanocomplex

Study Officials

  • Amr Abd El Aziz, Professor

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Mariam Elsagheer, Master's Candidate

CONTACT

00201096735935elsagheermariam@gmail.com

Mohamed Zayed, Assistant Professor

CONTACT

+20111148002Mradwan@dent.asu.edu.eg

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Candidate

Study Record Dates

First Submitted

March 1, 2021

First Posted

January 24, 2022

Study Start

January 1, 2021

Primary Completion

March 30, 2022

Study Completion

June 30, 2022

Last Updated

January 24, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
9 months

Locations

EG(1)