RecruitingEarly Phase 1NCT06708481

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

Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial


Sponsor

October 6 University

Enrollment

150 participants

Start Date

Aug 30, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 7 YearsMax Age: 14 Years

Inclusion Criteria5

  • Age (a range from 7-14 years of age was determined)
  • Good general health (absence of disease/no handicaps, to ensure oral care at home)
  • Preserved pulp vitality of the teeth.
  • Consolidated oral care daily.
  • Agreement by patient and parents (or guardians) to participate in the study

Exclusion Criteria3

  • Patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency).
  • Teeth revealing any restorations were excluded from the current study.
  • Any previous or planned WSL treatment.

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Interventions

DRUGP11-4, 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

DRUGP11-4, a self-assembling peptide with flouride

self assembling peptide with 500 ppm sodium fluoride

DRUGresin 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


Locations(1)

October 6 University

Cairo, Giza Governorate, Egypt

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NCT06708481


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