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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
Phase 1 trial testing PRG Barrier Coat in White Spot Lesions [Initial Caries] on Smooth Surface of Tooth in 60 participants. Status unknown.
30 March 2022
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 January 2021 |
| Primary completion | 30 March 2022 |
| Estimated completion | 30 June 2022 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- PRG Barrier Coat — full drug profile →
- Fluoride varnish
- MI paste — full drug profile →
Conditions studied
- White Spot Lesions [Initial Caries] on Smooth Surface of Tooth — all drugs for White Spot Lesions [Initial Caries] on Smooth Surface of Tooth →
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.
Verify or expand the search:
- PubMed search for NCT05202821
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Currently open trials in the same condition.
- NCT06696105 — Assessing the Effects of Resin Infiltration and Resin Modified Glass Ionomer on the Color Changes of White Spot Lesions · Phase 4 · active not recruiting
Other Ain Shams University trials
Trials by the same sponsor.
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- NCT07531030 — Posterior Pericapsular Deep Gluteal Block Combined With Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blo · NA · not yet recruiting
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- NCT07516535 — DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05202821 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 24 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05202821.
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