Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesions
NCT ID: NCT06708481
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
150 participants
INTERVENTIONAL
2024-08-30
2025-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Self-Assembling Peptide (P11-4)
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)
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
Self-Assembling Peptide (P11-4) with fluoride varnish
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).
P11-4, a self-assembling peptide with flouride
self assembling peptide with 500 ppm sodium fluoride
Resin Infilteration
ICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant
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
Interventions
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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
P11-4, a self-assembling peptide with flouride
self assembling peptide with 500 ppm sodium fluoride
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Teeth revealing any restorations were excluded from the current study.
* Any previous or planned WSL treatment.
7 Years
14 Years
ALL
Yes
Sponsors
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Al-Azhar University
OTHER
University of Science and Technology of Fujairah
UNKNOWN
October 6 University
OTHER
Responsible Party
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Dina El Kharadly
Lecturer in Pediatric Dentistry Department
Locations
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October 6 University
Cairo, Giza Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P-PD-24-03
Identifier Type: -
Identifier Source: org_study_id