An Early Phase 1 interventional study of P11-4, a self-assembling peptide and P11-4, a self-assembling peptide with flouride in White Spot Lesion, sponsored by October 6 University. Recruiting at 1 site in Egypt. Open to participants aged 7 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by October 6 University · Early Phase 1, Interventional, and Treatment
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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
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 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
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
October 6 University is the lead sponsor of 148 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
self-assembling peptide in a brush-on liquid applied after cleaning and chemical preparation.The P11-4 peptide, called Curodont Repair (Credentis; now manufactured by vVARDIS)
Drug: P11-4, a self-assembling peptide
CR Fluoride Plus (CRFP) (Credentis; now manufactured by vVARDIS) also includes 500 ppm sodium fluoride and is registered with the US Food and Drug Administration (NDC 72247-101) as an anticaries drug under the fluoride monograph (21CFR355).
Drug: P11-4, a self-assembling peptide with flouride
ICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant
Drug: resin infilteration
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
Also known as: Curodont- repair
self assembling peptide with 500 ppm sodium fluoride
Also known as: 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
Also known as: Icon
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: 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
Started Aug 2024 (actual). Primary completion is estimated for Feb 2025, 6 months after the start.
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