Effect of the Use of Self-Assembling Peptides Versus Resin Infiltration on Post Orthodontic White Spot Lesions: A Randomized Clinical Trial

This study aim was to Investigate color change of post orthodontic white spot lesion after using self- assembling peptide (CURODONT) and compare the color change of post orthodontic white spot lesion between CURODONT and ICON

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Key information

Conditions

White Spot Lesions

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Suez Canal University

Ismailia, Ismailia Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

No systemic diseases or medication affecting salivary flow.
16-25 years old.
Completed fixed orthodontic treatment.
Have one or more white spot lesions.
Good oral hygiene.
Co-operative patients approving the trial.

Exclusion criteria

Patients with Poor oral hygiene.
Xerostomia in which participants have evidence of reduced salivary flow.
Lack of compliance.
Participant in another trial.
Non carious lesion (enamel hypoplasia and dental fluorosis).
Presence of tetracycline pigmentation.
Filling on the labial surface.

Treatment and study plan

Self-Assembling Peptide (Curodont Repair)

Drug

Curodont is a minimally invasive dental treatment based on a biomimetic peptide technology designed to support the natural remineralization and repair of early-stage enamel caries lesions. The treatment is applied topically to the affected tooth surface and is intended to promote mineral deposition within subsurface enamel lesions, potentially contributing to lesion arrest or reversal and preservation of tooth structure.

Primary outcomes

Number of Participants with White Spot Lesions post orthodontic treatment assessed by Delta E

Time frame: 1 year

Number of Participants with White Spot Lesions Post-Orthodontic Treatment Assessed by ΔE (Delta E) is an outcome measure used to evaluate the presence and severity of enamel white spot lesions following completion of orthodontic treatment. Tooth color is assessed using a standardized colorimetric method, and the color difference (ΔE) between the affected and unaffected enamel is calculated. Participants are classified based on the presence of clinically detectable white spot lesions according to the predefined ΔE threshold, allowing for assessment of the incidence and severity of enamel demineralization after orthodontic treatment.
Delta E

Time frame: From enrollment to the end of treatment at 1 year

ΔE (Delta E) is a quantitative measure of color difference used to assess changes in tooth color or dental material color. It is calculated from colorimetric measurements obtained using a standardized color space, such as CIELAB, and represents the overall magnitude of color change between two measurements. In clinical dental studies, ΔE is commonly used to evaluate the degree of tooth discoloration, whitening, or color improvement following treatment, with lower values indicating less color difference and higher values indicating greater color change.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Acronym: WSL

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Aug 19, 2026
Registry last updated: Aug 19, 2026

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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Completed