NCT06708481

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: October 6 University · Academic / Other
• Sex: All
• Age: 7 Years – 14 Years
• Healthy volunteers: Accepted

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

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

Conditions

• White Spot Lesion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-30
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2024-11-27
• Last updated: 2024-11-27

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study