White Spot LesionsPhase 1WSLNCT07773714
Effect of the Use of Self-Assembling Peptides Versus Resin Infiltration on Post Orthodontic White Spot Lesions: A Randomized Clinical Trial
A Phase 1 study testing Self-Assembling Peptide (Curodont Repair) in people with White Spot Lesions, run by Suez Canal University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- Self-Assembling Peptide (Curodont Repair)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2023to 15 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- White Spot Lesions
- Being tested
- Self-Assembling Peptide (Curodont Repair)
- Keywords
- White Spot Lesions, Post-orthodontic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with White Spot Lesions Post Orthodontic Treatment | Active comparator | Resin infiltration (ICON) is a minimally invasive microinvasive dental treatment used to manage early-stage enamel caries lesions and non-cavitated white spot lesions. The procedure involves conditioning and drying the affected enamel, followed by application of a low-viscosity resin that penetrates the porous lesion and is subsequently light-cured. Resin infiltration is intended to arrest or slow the progression of early carious lesions by occluding the lesion microporosities and may also improve the esthetic appearance of white spot lesions. Receives: Drug: Self-Assembling Peptide (Curodont Repair) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with White Spot Lesions post orthodontic treatment assessed by Delta E
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.
Measured: 1 year
Delta E
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.
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start10 Apr 2023
- Primary completion15 May 2024
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Nour Shaban, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773714
- Sponsor's protocol ID
- 2022/485
- Acronym
- WSL
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: a description of the variables, or types of data, collected for each individual will be provided so that the data can be fully interpreted
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Self-Assembling Peptides Versus Resin Infiltration on Post Orthodontic White Spot Lesions: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07773714
- Acronym / sponsor ID
- WSL / 2022/485
- Conditions
- White Spot Lesions
- Keywords
- White Spot Lesions, Post-orthodontic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with White Spot Lesions Post Orthodontic Treatment | Active comparator | Drug: Self-Assembling Peptide (Curodont Repair)Resin infiltration (ICON) is a minimally invasive microinvasive dental treatment used to manage early-stage enamel caries lesions and non-cavitated white spot lesions. The procedure involves conditioning and drying the affected enamel, followed by application of a low-viscosity resin that penetrates the porous lesion and is subsequently light-cured. Resin infiltration is intended to arrest or slow the progression of early carious lesions by occluding the lesion microporosities and may also improve the esthetic appearance of white spot lesions. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-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. | Drug | Patients with White Spot Lesions Post Orthodontic Treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. a description of the variables, or types of data, collected for each individual will be provided so that the data can be fully interpreted
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Self-Assembling Peptide (Curodont Repair) in people with White Spot Lesions, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with White Spot Lesions post orthodontic treatment assessed by Delta E (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.