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

NCT03927794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-12-15

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

OTHER

Self-Assembling Peptide P11-4

Self-Assembling Peptide P11-4 promotes subsurface biomimetic remineralization of enamel. It is a small peptide comprising 11 amino acids that when applied to an initial carious lesion diffuses into the body of the lesion, re-assembles itself into fibrils forming larger fibers and hence a 3-dimensional (3-D) matrix is formed. Natural remineralization driven by saliva is promoted through the surface of the P11-4 by increasing the surface area for calcium phosphate deposition. As a result, mineralization of the subsurface lesion occurs possibly due to the formation of de novo hydroxyapatite crystals on the surface of the P11-4 fibers.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Noha SA Kabil, PHD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-09-01
Completion
2021-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03927794 on ClinicalTrials.gov