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

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06708481

Enrollment

150

Registered

2024-11-27

Start date

2024-08-30

Completion date

2025-02-28

Last updated

2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion

Keywords

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

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

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

Interventions

DRUGP11-4, 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

DRUGP11-4, a self-assembling peptide with flouride

self assembling peptide with 500 ppm sodium fluoride

DRUGresin 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double Blind

Eligibility

Sex/Gender

ALL

Age

7 Years to 14 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Esthetic Improvement of white spot lesion	6 months	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
Tooth remineralization	6 months	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

Secondary

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

Countries

Egypt

Contacts

Primary ContactDina El Kharadly, PHD

dina.yousry.dent@o6u.edu.eg02 38355276

Backup Contactnada adel

nada.adel.dent@o6u.edu.eg02 38355276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026