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NCT Number: NCT06708481

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

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

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Key information

Conditions

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

October 6 University

Cairo, Giza Governorate, Egypt

Location status: Recruiting

Location contact

Dina EL Kharadly, PHD

CONTACT

[email protected]

02 38355276

About this study

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
  • 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

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Curodont- repair

P11-4, a self-assembling peptide with flouride

Drug

self assembling peptide with 500 ppm sodium fluoride

Other names: Curodont- repair with fouride

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

Other names: Icon

Primary outcomes

  1. Esthetic Improvement of white spot lesion

    Time frame: 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

  2. Tooth remineralization

    Time frame: 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 outcomes

  1. Patient Satisfaction

    Time frame: 6 months

    Likert 5-point faces scale ranging from very sad to very happy

Study contacts

Contact information is provided by the study sponsor or research team.

Dina El Kharadly, PHD

CONTACT

[email protected]

02 38355276

nada adel

CONTACT

[email protected]

02 38355276

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Collaborators

  • Al-Azhar University
  • University of Science and Technology of Fujairah

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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