October 6 University
Cairo, Giza Governorate, Egypt
Location status: Recruiting
NCT Number: NCT06708481
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
Interested in participating?
Request Info7 year–14 year
All sexes
Interventional
Early Phase 1
Cairo, Giza Governorate, Egypt
Location status: Recruiting
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
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
Outcome measuring Device: Visual and Clinical examination by operator Outcome measuring Unit : Numerical score from 0-6
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Curodont- repair
self assembling peptide with 500 ppm sodium fluoride
Other names: Curodont- repair with fouride
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
Other names: Icon
Time frame: 6 months
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
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
Likert 5-point faces scale ranging from very sad to very happy
Contact information is provided by the study sponsor or research team.
Dina El Kharadly, PHD
CONTACT
nada adel
CONTACT
October 6 University
Other
Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial
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