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

Last updated: November 25, 2024
Sponsor: October 6 University
Overall Status: Active - Recruiting

Phase

1

Condition

Smallpox

Treatment

P11-4, a self-assembling peptide

P11-4, a self-assembling peptide with flouride

resin infilteration

Clinical Study ID

NCT06708481
P-PD-24-03
  • Ages 7-14
  • All Genders
  • Accepts Healthy Volunteers

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with periodontal diseases (periodontal pockets or dental mobility) orradiologically identified pathologies (periapical radiolucency).

  • Teeth revealing any restorations were excluded from the current study.

  • Any previous or planned WSL treatment.

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: P11-4, a self-assembling peptide
Phase: 1
Study Start date:
August 30, 2024
Estimated Completion Date:
February 28, 2025

Study Description

Patient/population:

Patients that range from 7-14 years of age with with at least one non-cavitated WSL located on smooth surfaces of maxillary or mandibular permanent teeth and comparable in size, opacity, and whitish appearance.

Intervention:

I1: Self-Assembling Peptide (P11-4) I2: Self-Assembling Peptide (P11-4) with fluoride varnish

Comparator Resin Infiltration

Outcome:

Primary outcome

  • Esthetic Improvement of white spot lesion

Outcome measure: Photographic analysis Outcome measuring Device: Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software.

Outcome measuring unit: change in Percentage

• Tooth remineralization

  1. Outcome measure: International Caries Detection and Assessment System (ICDAS) score.

    Outcome measuring Device: Visual and Clinical examination by operator Outcome measuring Unit : Numerical score from 0-6

  2. Outcome measure: Quantitative light Fluorescence score from WSL Outcome measuring Device: Diagnodent Pen Outcome measuring Unit: Numerical score from 0-99

Secondary outcome

Outcome measure: Patient Satisfaction Outcome measuring Device Likert 5-point faces scale ranging from very sad to very happy

Outcome measuring Unit :Numerical score from 1-5

Study design: Randomized clinical trial Time: 6 months

Connect with a study center

  • October 6 University

    Cairo, Giza
    Egypt

    Active - Recruiting

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