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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07773714
Acronym
WSL
Enrollment
42
Registered
2026-08-19
Start date
2023-04-10
Completion date
2025-09-15
Last updated
2026-08-19

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

Conditions

White Spot Lesions

Keywords

White Spot Lesions, Post-orthodontic

Brief summary

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

Interventions

DRUGSelf-Assembling Peptide (Curodont Repair)

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.

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with White Spot Lesions post orthodontic treatment assessed by Delta E1 yearNumber 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 EFrom enrollment to the end of treatment at 1 yearΔE (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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026