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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
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
self assembling peptide with 500 ppm sodium fluoride
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
October 6 University
Cairo, Giza Governorate, Egypt
RECRUITINGEsthetic 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: Percentage change
Time frame: 6 months
Tooth remineralization
ICDAS score Outcome Measure: ICDAS score Outcome measuring device: Visual and Clinical examination by operator Outcome measuring unit: Numerical value from 0-6 Outcome Measure: Quantitative Light Fluorescence score from WSL Outcome measuring device: Diagnodent pen Outcome measuring unit: Numerical value ranging from 0 to 99
Time frame: 6 months
Patient Satisfaction
Likert 5-point faces scale ranging from very sad to very happy
Time frame: 6 months
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