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NCT03927794
Remineralization of White Spot Lesions Using Self-Assembling Peptide P11-4 in Primary Anterior Teeth A Randomized Clinical Trial
NA trial testing Self-Assembling Peptide P11-4 in White Spot Lesions [Initial Caries] on Smooth Surface of Tooth in 11 participants. Completed in 1 September 2021.
1 September 2021
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 1 September 2020 |
| Primary completion | 1 September 2021 |
| Estimated completion | 1 September 2021 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Self-Assembling Peptide P11-4
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 3 to 5, 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
This study is a randomized controlled clinical trial on primary anterior teeth of 3-5 year-old patients suffering from white spot lesions (ICDAS system II scores 1-2). Forty four teeth will be divided into two groups where Group 1 (n=22 teeth) will receive Self-Assembling Peptide P11-4. Group 2 (n=22 teeth) will receive Topical Fluoride Varnish Application. Assessment will be done at baseline using the International Caries Detection and Assessment System II (ICDAS II) scoring system and Light Induced Fluorescence using Soprolife System (Acteon, La Ciotat, France) and then after 3 months, 6 months and 1 year. The assessment of the baseline and follow up data will be performed by the main investigator.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Biomaterials via peptide assembly: Design, characterization, and application in tissue engineering.
Gray VP, Amelung CD, Duti IJ, Laudermilch EG, et al · · 2022 · cited 47× · PMID 34710626 · DOI 10.1016/j.actbio.2021.10.030
Verify or expand the search:
- PubMed search for NCT03927794
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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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
- NCT06839027 — Arterial to Central co2gap in Relation to Outcome After Cardiopulmonary Bypass · not yet recruiting
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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 NCT03927794 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 15 December 2021
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/NCT03927794.
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