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Recruiting NCT06708481

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

Early Phase I Interventional White Spot Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: P11-4, a self-assembling peptide, P11-4, a self-assembling peptide with flouride, resin infilteration.
Who it may be relevant to
Registry conditions: White Spot Lesion. Basic parameters: 7 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed 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

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

Primary outcome measures

  • Esthetic Improvement of white spot lesion [Time frame: 6 months]
  • Tooth remineralization [Time frame: 6 months]
Secondary outcome measures (1)
  • Patient Satisfaction [Time frame: 6 months]

Eligibility criteria

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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • October 6 University — Cairo

Identifiers

NCT: NCT06708481 · P-PD-24-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗