Clinical Evaluation of the Efficacy of SPR-G Barrier Coat Versus Fluoride Varnish Versus MI Paste in the Treatment of Early White Spot Lesions in Pediatric Patients

January 17, 2022 updated by: Mariam Alsagheer, Ain Shams University

Clinical Evaluation of the Efficacy of SPR-G (Surface Pre-reacted Glass Ionomer) Barrier Coat Versus Fluoride Varnish Versus the MI Paste (CPP-ACP) in the Treatment of Early White Spot Lesions in Pediatric Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A total of sixty (60) patients with early white spot lesions will be randomly selected to share in this study from the out-patient clinic of pedodontics and orthodontic department, Faculty of dentistry, Ain Shams University.

An informed consent will be signed by the patients and parents before their enrollment in the current study in which the aim of the study, the methodology and possible complications will be clearly described. This research will be reviewed by the research ethics committee, Faculty of dentistry, Ain Shams University. This In-vivo study will aim to evaluate the effectiveness of the SPR-G filler material sealants when compared to the fluoride varnish and the MI paste.

Precise medical, dental and family history will be taken from all patients through a direct interview and diagnostic sheet.

Teeth will be polished using a polishing brush and paste, and dried thoroughly before being examined.

Clinical examination will be done using a dental mirror and aided by the tactile detection of a dental explorer under LED illumination to make sure that the patients fulfill the inclusion criteria, followed by radiographic examination. All examination and follow up procedures will be done by the same operator to ensure standardization.

Patient's Grouping:

Selected patients will be randomly divided into three groups:

  • Group (I): patients will receive Fluoride varnish ttt.
  • Group (II): patients will receive PR-G Barrier coat
  • Group (III): Patients will receive MI Paste (CPP-ACP)

Patients who fail to show up at the follow up examinations will be automatically excluded from the study. Patients who are no longer willing to continue in the study will have the right to quit at any time.

Patient information will be gathered and stored in the patient examination chart of the outpatient clinic, Department of Pediatric Dentistry, faculty of Dentistry, Ain Shams University. All information will be kept as a hard copy and as an electronic one as well. Patient information will be guarded as confidential information that should never be revealed at all times. This file will remain with the investigator during the study.

Outcome measurement:

9 months' in vivo evaluation of functional & biological aspects of the three modalities regarding retention, stability, oral hygiene and patient satisfaction.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Al Waili
      • Cairo, Al Waili, Egypt, 11566
        • Recruiting
        • ain shams University
        • Contact:
        • Principal Investigator:
          • Mariam Alsagheer, Master's Candidate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group of 20 participants receiving fluoride varnish
*Group (I): patients will receive Fluoride varnish ttt.
Drug: Fluoride varnish
First group will be receiving Fluoride varnish every 3 months
Other Names:
  • Cavity Shield
Experimental: group of 20 participants receiving PR-G Barrier coat
*Group (II): patients will receive PR-G Barrier coat
Drug: PRG Barrier Coat
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
Other Names:
  • SPRG Barrier Coat
Active Comparator: group of 20 participants receiving MI Paste (CPP-ACP)
*Group (III): Patients will receive MI Paste (CPP-ACP)
Drug: MI paste
Third group will be receiving MI paste
Other Names:
  • RECALDENT™
  • (CPP-ACP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the size of the white spot lesions using photographic assessment
Time Frame: 9 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remineralization of the enamel surface
Time Frame: 9 months
Using photographic assessment with the aid of a software to asses the change in the height and width (i.e surface area) of the white spot lesion
9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction and motivation towards treatment using a questionnaire at the end of the treatment
Time Frame: 9 months
Closed ended questions with strongly agree rated with 5, agree rated 4, neutral rated 3, disagree rated 2 and strongly disagree rated 1. Higher values will denote positive results lower values indicating negative results
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Amr Abd El Aziz, Professor, ain shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED 18-7M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

9 months

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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