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

Phase 1

• Conditions: White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
• Interventions: Drug: PRG Barrier Coat; Drug: Fluoride varnish; Drug: MI paste

• Registration Number: NCT05202821
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-03-01
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-17
• Last Update Submitted: 2022-01-17
• Study First Posted: 2022-01-24
• Last Update Posted: 2022-01-24
• Primary Completion: 2022-03-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group of 20 participants receiving PR-G Barrier coat	PRG Barrier Coat	\*Group (II): patients will receive PR-G Barrier coat
group of 20 participants receiving fluoride varnish	Fluoride varnish	\*Group (I): patients will receive Fluoride varnish ttt.
group of 20 participants receiving MI Paste (CPP-ACP)	MI paste	\*Group (III): Patients will receive MI Paste (CPP-ACP)

Primary Outcome Measures

Name	Time	Method
Change in the size of the white spot lesions using photographic assessment	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

Secondary Outcome Measures

Name	Time	Method
Remineralization of the enamel surface	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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Al Waili, Egypt