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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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05202821
Enrollment
60
Registered
2022-01-24
Start date
2021-01-01
Completion date
2022-06-30
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

White spot lesions, Fluoride varnish, MI paste (CPP_ACP), SPRG- Barrier coat

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.

Interventions

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

DRUGFluoride varnish

First group will be receiving Fluoride varnish every 3 months

Third group will be receiving MI paste

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the size of the white spot lesions using photographic assessment9 monthsparticipants 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

MeasureTime frameDescription
Remineralization of the enamel surface9 monthsUsing 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

Other

MeasureTime frameDescription
Patient satisfaction and motivation towards treatment using a questionnaire at the end of the treatment9 monthsClosed 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

Countries

Egypt

Contacts

Primary ContactMariam Elsagheer, Master's Candidate
elsagheermariam@gmail.com00201096735935
Backup ContactMohamed Zayed, Assistant Professor
Mradwan@dent.asu.edu.eg+20111148002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026