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NCT05202821

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

Status unknown Phase 1 Last updated 24 January 2022
What this trial tests

Phase 1 trial testing PRG Barrier Coat in White Spot Lesions [Initial Caries] on Smooth Surface of Tooth in 60 participants. Status unknown.

Timeline
1 January 2021
Primary endpoint
30 March 2022
30 June 2022

Quick facts

Lead sponsorAin Shams University
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment60
Start date1 January 2021
Primary completion30 March 2022
Estimated completion30 June 2022
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Ain Shams University

Who can join

Adults 10 to 16, any sex, with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for White Spot Lesions [Initial Caries] on Smooth Surface of Tooth

Currently open trials in the same condition.

Other Ain Shams University trials

Trials by the same sponsor.

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Data sources for this page

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