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Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesions

NCT06708481 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-11-27

No results posted yet for this study

Summary

Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions

Conditions

  • White Spot Lesion

Interventions

DRUG

P11-4, a self-assembling peptide

rationally designed peptide, the monomers of which self-assemble into a biocompatible fibrillar scaffold that mimics the enamel matrix in response to particular environmental cues

DRUG

P11-4, a self-assembling peptide with flouride

self assembling peptide with 500 ppm sodium fluoride

DRUG

resin infilteration

Improvement of white spot lesions appearance by infiltration occurs due to a change in the refractive index since the refractive index of enamel (1.62-1.65) is different than that of air (1.00). Infiltration of the lesions with an infiltrate that has a refractive index of 1.52 is able to mask the lesion

Sponsors & Collaborators

  • Al-Azhar University

    collaborator OTHER

  • University of Science and Technology of Fujairah

    collaborator UNKNOWN

  • October 6 University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2025-02-28
Completion
2025-02-28
FDA Drug
Yes

Countries

  • Egypt

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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 NCT06708481 on ClinicalTrials.gov