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

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

Study Overview

• Status: Recruiting
• Conditions: White Spot Lesion
• Intervention / Treatment: Drug: P11-4, a self-assembling peptide; Drug: P11-4, a self-assembling peptide with flouride; Drug: resin infilteration

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

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Dina EL Kharadly, PHD; Phone Number: 02 38355276; Email: dina.yousry.dent@o6u.edu.eg
• Study Contact Backup: Name: nada adel; Phone Number: 02 38355276; Email: nada.adel.dent@o6u.edu.eg

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt
      • Recruiting
      • October 6 University
      • Contact: Dina EL Kharadly, PHD; Phone Number: 02 38355276; Email: dina.yousry.dent@o6u.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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; Other Names: Curodont- repair
Experimental: 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).	Drug: P11-4, a self-assembling peptide with flouride; self assembling peptide with 500 ppm sodium fluoride; Other Names: Curodont- repair with fouride
Active Comparator: Resin Infilteration; ICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant	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; Other Names: Icon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Likert 5-point faces scale ranging from very sad to very happy	6 months

Collaborators and Investigators

• Sponsor: October 6 University
• Collaborators: Al-Azhar University; University of Science and Technology of Fujairah

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Estimated): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Resin Infilteration , white spot lesions , Self assembling peptide, remineralization
• Additional Relevant MeSH Terms: Skin Diseases; Exanthema
• Other Study ID Numbers: P-PD-24-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes