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NCT03927794

Remineralization of White Spot Lesions Using Self-Assembling Peptide P11-4 in Primary Anterior Teeth A Randomized Clinical Trial

Completed NA Last updated 15 December 2021
What this trial tests

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.

Timeline
1 September 2020
Primary endpoint
1 September 2021
1 September 2021

Quick facts

Lead sponsorAin Shams University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment11
Start date1 September 2020
Primary completion1 September 2021
Estimated completion1 September 2021
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

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):

  1. 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:

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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