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

NCT06708481 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: P-PD-24-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

White Spot Lesion

Keywords

Resin Infilteration , white spot lesions , Self assembling peptide, remineralization

Outcome Measures

Primary Outcomes (2)

• 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

  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

  6 months

Secondary Outcomes (1)

• Patient Satisfaction

  6 months

Study Arms (3)

Self-Assembling Peptide (P11-4)

EXPERIMENTAL

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

Self-Assembling Peptide (P11-4) with fluoride varnish

EXPERIMENTAL

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

Resin Infilteration

ACTIVE COMPARATOR

ICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant

Drug: resin infilteration

Interventions

P11-4, a self-assembling peptide DRUG

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 (P11-4)

P11-4, a self-assembling peptide with flouride DRUG

self assembling peptide with 500 ppm sodium fluoride

Also known as: Curodont- repair with fouride

Self-Assembling Peptide (P11-4) with fluoride varnish

resin infilteration DRUG

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

Resin Infilteration

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age (a range from 7-14 years of age was determined)
• 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

You may not qualify if:

• Patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency).
• Teeth revealing any restorations were excluded from the current study.
• Any previous or planned WSL treatment.

Sponsors & Collaborators

• October 6 University: lead
• Al-Azhar University: collaborator
• University of Science and Technology of Fujairah: collaborator

Study Sites (1)

October 6 University

Cairo, Giza Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

icon infiltrant

Central Study Contacts

Dina El Kharadly, PHD

CONTACT

02 38355276; dina.yousry.dent@o6u.edu.eg

nada adel

CONTACT

02 38355276; nada.adel.dent@o6u.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Pediatric Dentistry Department

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: November 27, 2024
• Study Start: August 30, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

EG (1)