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White Spot Lesions on Smooth Surface of ToothWSL-CurodontNCT07664046

The Effectiveness of the Self-Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions

A study testing Self-assembling peptide P11-4 and Fluoride varnish in people with White Spot Lesions on Smooth Surface of Tooth, run by Medical University of Warsaw at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is three-arm Randomized Controlled Trial. The main goal is to evaluate the effectiveness of self-assembling peptide P11-4 (SAP P11-4) in the remineralization of enamel carious white spot lesions. Read more about this study

Who is it for?
Ages 10 to 18 years
What is being tested?
Self-assembling peptide P11-4 and Fluoride varnish
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 sitePoland
Study dates
2 Feb 2026to 14 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age >10 years and <18 years.
  • Presence of at least 2 active enamel carious white spot lesions on a smooth tooth surface (labial/buccal surfaces of permanent teeth) based on International Caries Detection (ICDAS II) and Assessment System -Lesion Activity Assessment (ICDAS-LAA), and Lesion Activity Assessment (LAA criteria).
  • Tooth eligible for treatment:
  • Vital pulp,
  • no loss of hard dental tissues within the investigated lesion (ICDAS II) code 1 or 2 , LAA code 1, ICDAS-LAA>7;
  • QLF score parameters consistent with demineralization without loss of tissue continuity- code 1 or 2),
Show all 11Show fewer
  • no history of trauma to the tooth.
  • Systemically healthy patient.
  • No contraindications to the use of fluoride preparations.
  • No fixed orthodontic appliance.
  • Written consent for participation in the study signed by the legal guardian, or by the legal guardian and the patient.

Who cannot join

  • Systemic diseases or chronic medication use due to chronic conditions.
  • Viral/bacterial illness on the day of the visit, e.g., herpetic stomatitis, influenza, tonsillitis (temporary restriction).
  • Pregnancy or breastfeeding.
  • Allergy to any component of the SAP P11-4 preparation or the fluoride varnish.
  • Professional fluoride prophylaxis performed <3 months ago.
  • Presence of cavitation (loss of hard tissues) in the treated tooth - ICDAS II code ≥3, ICDAS-LAA<7, LAA code 0, 2-9.
Show all 12Show fewer
  • Carious WSL previously treated with the Icon resin infiltrant (methacrylate resin).
  • Developmental enamel defects.
  • Patient undergoing orthodontic treatment with fixed appliances.
  • Inability to ensure regular follow-up visits.
  • Lack of cooperation from the guardian or the patient.
  • Refusal to participate in the study and/or absence of written consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Turska-Szybka contact

+48 22 116 64 24

pedodoncja@wum.edu.pl

Poland1 site, 1 recruiting

  • University Clinical Center of the Medical University of Warsaw, Department of Pediatric Dentistry

    Warsaw, Masovian Voivodeship, 02-097

    Secretariat of the Department of Pediatric Dentistry, +48 22 116 64 24, pedodoncja@wum.edu.pl

    Dorota Olczak-Kowalczyk, Prof.

    Recruiting

Other trials in Poland

About this study

Official title: A Three-arm Randomized Controlled Trial Evaluating the Effectiveness of Self- Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions

This is three-arm Randomized Controlled Trial. The main goal is to evaluate the effectiveness of self-assembling peptide P11-4 (SAP P11-4) in the remineralization of enamel carious white spot lesions. Participants with carious white spot lesions will be assigned to one of three study groups and remineralisation agents will be applied according to the study protocol. The primary objective is to assess changes in the carious white spot lesions over time using quantitative light-induced fluorescence and clinical evaluation.

Read the detailed description

This study will be conducted at an academic center. Recruitment will include patients aged 10 to 18 years presenting with carious white spot lesions on the smooth surfaces of permanent teeth at the Department of Pediatric Dentistry, Medical University of Warsaw. The planned study duration is 1 year. After assessment of the inclusion and exclusion criteria and enrollment into the study, participants will undergo randomization and will be allocated to 1 of 3 study groups.

Group A will receive a single application of Curodont Repair (self-assembling peptide P11-4) at the first visit, together with fluoride varnish application every 3 months (Duraphat Fluoride Varnish, Colgate, 22,600 ppm fluoride). Group B will receive repeated applications of Curodont Repair at the first visit, after 3 months, together with fluoride varnish application every 3 months. Group C, the control group, will receive only fluoride varnish every 3 months.

There is currently limited evidence regarding the effectiveness of repeated applications of remineralization agents containing self-assembling peptide P11-4. In addition, this study includes a relatively long follow-up period, allowing evaluation of the durability of the treatment effect over time.

At each follow-up visit, scheduled every 3 months, white spot lesions will be assessed using quantitative light-induced fluorescence (QLF) and visual clinical examination.

Being tested
Self-assembling peptide P11-4, Fluoride varnish
Keywords
Curodont Repair, SAP P11-4, Self-Assembling Peptide P11-4, Remineralisation, Quantitative Light-Induced Fluorescence, Fluoride Varnish, Pediatric Dentistry, White Spot Lesions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-assembling peptide P11-4Other

    Self-assembling peptide P11-4 will be applied on enamel carious white spot lesions according to the study protocol. In the single-application group (group A), the agent will be applied once at the first visit(baseline). In the repeated-application group (group B), the agent will be applied at the first visit (baseline) and after 3 months.

  • Fluoride varnishOther

    Fluoride varnish will be applied every 3 months according to the study protocol.

Study groups in NCT07664046
Study groupRoleWhat they receive
Single Application of Curodont Repair Plus Fluoride VarnishExperimentalParticipants will receive a single application of Curodont Repair (self-assembling peptide P11-4) at the first visit (baseline) and fluoride varnish application every 3 months (including baseline visit)
Receives: Other: Self-assembling peptide P11-4; Other: Fluoride varnish
Repeated Application of Curodont Repair Plus Fluoride VarnishExperimentalParticipants will receive applications of Curodont Repair (self-assembling peptide P11-4) at the first visit (baseline), after 3 months, together with fluoride varnish application every 3 months (including baseline visit).
Receives: Other: Self-assembling peptide P11-4; Other: Fluoride varnish
Fluoride Varnish OnlyActive comparatorParticipants will receive fluoride varnish application every 3 months only.
Receives: Other: Fluoride varnish

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Fluorescence Loss (ΔF) of White Spot Lesions From Baseline to 12 Months Assessed by Quantitative Light-Induced Fluorescence

    The primary outcome measure is the change in fluorescence loss of white spot lesions from baseline to the 12-month follow-up, assessed using quantitative light-induced fluorescence (QLF). Fluorescence loss will be measured using the QLF parameter ΔF and expressed as percentage fluorescence loss (%). More negative ΔF values indicate greater mineral loss. The change will be calculated as the ΔF value at 12 months minus the ΔF value at baseline. A positive change in ΔF from baseline, indicating an increase in ΔF toward zero, will indicate lesion remineralization. A negative change in ΔF from baseline will indicate lesion demineralization.

    Measured: baseline and 12 months follow-up

  2. Change in lesion volume ΔQ of White Spot Lesions From Baseline to 12 Months Assessed by Quantitative Light-Induced Fluorescence

    The primary outcome measure is the change in QLF lesion volume (ΔQ) from baseline to the 12-month follow-up. ΔQ will be assessed using quantitative light-induced fluorescence (QLF) and expressed as % × mm². The change will be calculated as the ΔQ value at 12 months minus the ΔQ value at baseline. More negative ΔQ values indicate larger or more severe lesions. Therefore, a positive change in ΔQ from baseline indicates lesion improvement, whereas a negative change in ΔQ from baseline indicates lesion progression.

    Measured: from baseline to the 12-month follow-up

Secondary outcomes (11)

  1. Change in QLF Fluorescence Loss (ΔF) of White Spot Lesions From Baseline to Each Follow-up Visit

    Fluorescence loss will be assessed using the QLF parameter ΔF and expressed as percentage fluorescence loss (%). More negative ΔF values indicate greater mineral loss. The change will be calculated as the ΔF value at each follow-up visit minus the ΔF value at baseline. A positive change in ΔF from baseline, indicating an increase in ΔF toward zero, will indicate lesion remineralization. A negative change in ΔF from baseline will indicate lesion demineralization.

    Measured: Baseline, 3 months, 6 months, 9 months, and 12 months

  2. Change in Lesion Area of White Spot Lesions From Baseline to Each Follow-up Visit

    Lesion area will be assessed using quantitative light-induced fluorescence (QLF) and expressed in square millimeters (mm²). The change will be calculated as the lesion area at each follow-up visit minus the lesion area at baseline. A decrease in lesion area from baseline indicates lesion improvement, whereas an increase in lesion area from baseline indicates lesion progression.

    Measured: Baseline, 3 months, 6 months, 9 months, and 12 months

  3. Change in QLF Lesion Volume (ΔQ) of White Spot Lesions From Baseline to Each Follow-up Visit

    Lesion volume will be assessed using the QLF parameter ΔQ and expressed as % × mm². More negative ΔQ values indicate larger or more severe lesions. An increase in ΔQ toward zero, or a positive change in ΔQ from baseline, will indicate lesion improvement. A decrease in ΔQ, or a negative change in ΔQ from baseline, will indicate lesion progression.

    Measured: Baseline, 3 months, 6 months, 9 months, and 12 months

  4. Mean ICDAS II Score From Baseline to Each Follow-up Visit

    Caries lesion severity will be assessed using the International Caries Detection and Assessment System II (ICDAS II). The ICDAS II score ranges from 0 to 6, where 0 indicates a sound tooth surface and 6 indicates an extensive distinct cavity with visible dentin. Higher scores indicate greater caries lesion severity.

    Measured: Baseline, 3 months, 6 months, 9 months, and 12 months

  5. Mean ICDAS-Lesion Activity Assessment Score From Baseline to Each Follow-up Visit

    Lesion activity will be assessed using the ICDAS-Lesion Activity Assessment (ICDAS-LAA) criteria. The ICDAS-LAA score is calculated by summing points assigned for clinical parameters including visual appearance, gingival inflammation with plaque stagnation, and surface texture. The total score ranges from 4 to 11 points, with scores ≤7 indicating inactive caries and scores >7 indicating active caries. Higher scores indicate greater lesion activity.

    Measured: Baseline, 3 months, 6 months, 9 months, and 12 months

  6. Number of Lesions in Each Nyvad Lesion Activity Assessment Category From Baseline to Each Follow-up Visit

    Lesion activity will be assessed using the Nyvad Lesion Activity Assessment (LAA) criteria. Each lesion will be classified into one of the following categories: 0 = sound surface, 1 = active caries with intact surface, 2 = active caries with surface discontinuity, 3 = active caries with cavity, 4 = inactive caries with intact surface, 5 = inactive caries with surface discontinuity, 6 = inactive caries with cavity, 7 = filling with sound surface, 8 = filling with active caries, and 9 = filling with inactive caries. Results will be reported as the number of lesions in each category. Higher category numbers do not necessarily indicate a better or worse outcome, as the categories represent lesion/restoration status and caries activity.

    Measured: Baseline, 3 months, 6 months, 9 months, and 12 months

  7. Mean Plaque Index Score From Baseline to Each Follow-up Visit

    Dental plaque accumulation will be assessed using the Plaque Index (PLI). The PLI is scored from 0 to 3, where 0 indicates no plaque and 3 indicates abundant soft deposits. The mean PLI score will be calculated for each participant based on four surfaces per tooth. Higher scores indicate greater plaque accumulation.

    Measured: Baseline, 3 months, 6 months, 9 months, and 12 months

  8. Mean Gingival Index Score From Baseline to Each Follow-up Visit

    Gingival inflammation will be assessed using the Gingival Index (GI). The GI is scored from 0 to 3, where 0 indicates normal gingiva and 3 indicates severe inflammation. The mean GI score will be calculated for each participant based on four surfaces per tooth. Higher scores indicate worse gingival inflammation. The results will be interpreted as follows: 0 = healthy gingiva, 0.1-1.0 = mild inflammation, 1.1-2.0 = moderate inflammation, and 2.1-3.0 = severe inflammation.

    Measured: Baseline, 3 months, 6 months, 9 months, and 12 months

  9. Percentage of Sites With Bleeding on Probing From Baseline to Each Follow-up Visit

    Gingival status will be assessed using Bleeding on Probing (BOP). BOP will be expressed as the percentage of sites with bleeding on probing. Gingival status will be categorized as healthy/no gingivitis when BOP is <10%, localized gingivitis when BOP is 10-30%, and generalized gingivitis when BOP is >30%.The BOP percentage (BOP%) will be calculated as: BOP% = (Number of bleeding sites ÷ Total number of sites examined) × 100

    Measured: Baseline, 3 months, 6 months, 9 months, and 12 months

  10. Mean Visual Analogue Scale Score for Patient-reported Tolerability

    Patient-reported tolerability will be assessed using the Visual Analogue Scale. The scale ranges from 0 to 10, with higher scores indicating worse tolerability.

    Measured: Baseline, 3 months, 6 months, 9 months, and 12 months

  11. Number of Adverse Events Throughout the Study Period

    Occurrence of adverse events (AEs) recorded throughout the study period. Adverse events will be reported as the number of participants experiencing at least one adverse event.

    Measured: Baseline through 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start2 Feb 2026
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion14 Dec 2027 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a parallel design to one of three study groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07664046
Sponsor's protocol ID
CURODONT-WSL-2026
Acronym
WSL-Curodont
Status last verified
Jun 2026
First submitted
10 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • ÜÇTAŞLI, M. B., AKGÜL, S., UYSAL, G. Ç., AHISHA, C. D., KESKİN, A. Ş., & TOPBAŞ, N. K. (2025). SCIENTIFIC FOUNDATIONS AND CLINICAL DIRECTIONS IN DENTISTRY: REMINERALIZATION, RADIATION AND RESTORATION. In SCIENTIFIC FOUNDATIONS AND CLINICAL DIRECTIONS IN DENTISTRY: REMINERALIZATION, RADIATION AND RESTORATION. Zenodo. https://doi.org/10.5281/zenodo.15670487

  • Parums DV. Editorial: The 2024 Revision of the Declaration of Helsinki and its Continued Role as a Code of Ethics to Guide Medical Research. Med Sci Monit. 2024 Dec 1;30:e947428. doi: 10.12659/MSM.947428.

    PubMed 39616449

  • Hussain U, Kunwar SS, Khan UW, Kamran MA, Thakfan AS, Alshahrani OA, Rehman A, Niazi FH, Shah AM, Alam S, Campobasso A. Efficacy of various interventions for the management of white spot lesions associated with fixed orthodontic treatment: a systematic review and network meta-analysis of randomized controlled trials. BMC Oral Health. 2026 Feb 21;26(1):358. doi: 10.1186/s12903-026-07755-3.

    PubMed 41723426

  • Soliman EM, Abdelfattah WM, Mohamed DR, Nagui DA, Holiel AA. Clinical evaluation of the remineralizing potential of biomimetic scaffolds on enamel white spot lesions: A 12-month randomized controlled trial. J Dent. 2026 Mar;166:106303. doi: 10.1016/j.jdent.2025.106303. Epub 2025 Dec 16.

    PubMed 41412271

  • Sawair FA, Ryalat S, Shayyab M, Saku T. The unstimulated salivary flow rate in a jordanian healthy adult population. J Clin Med Res. 2009 Oct;1(4):219-25. doi: 10.4021/jocmr2009.10.1267. Epub 2009 Oct 16.

    PubMed 22461872

  • Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

    PubMed 5237684

  • Patel JS, Shin D, Willis L, Zai A, Kumar K, Thyvalikakath TP. Comparing gingivitis diagnoses by bleeding on probing (BOP) exclusively versus BOP combined with visual signs using large electronic dental records. Sci Rep. 2023 Oct 10;13(1):17065. doi: 10.1038/s41598-023-44307-z.

    PubMed 37816902

  • Elaziz BSA, Hamdy D, Galal M, Khattab NMA. The remineralizing ability of self-assembling peptide P11-4, 2% arginine enriched sodium fluoride and functionalized tri calcium phosphate fluoride varnishes in treatment of white spot lesions - a randomized controlled trial. BDJ Open. 2025 Jul 27;11(1):70. doi: 10.1038/s41405-025-00353-5.

    PubMed 40715066

  • Nyvad B, Baelum V. Nyvad Criteria for Caries Lesion Activity and Severity Assessment: A Validated Approach for Clinical Management and Research. Caries Res. 2018;52(5):397-405. doi: 10.1159/000480522. Epub 2018 Mar 5.

    PubMed 29506010

  • Ekstrand KR, Martignon S, Ricketts DJ, Qvist V. Detection and activity assessment of primary coronal caries lesions: a methodologic study. Oper Dent. 2007 May-Jun;32(3):225-35. doi: 10.2341/06-63.

    PubMed 17555173

  • Dikmen B. Icdas II criteria (international caries detection and assessment system). J Istanb Univ Fac Dent. 2015 Oct 21;49(3):63-72. doi: 10.17096/jiufd.38691. eCollection 2015.

    PubMed 28955548

  • Ding L, He D, Zheng S, Zhou X, Li H, Xi Y, Wang X, Sun X. In-vitro and in-vivo comparative studies of treatment effects on enamel demineralization during orthodontic therapy: implications for clinical early-intervention strategy. Clin Oral Investig. 2024 Sep 24;28(10):545. doi: 10.1007/s00784-024-05944-4.

    PubMed 39316130

  • Oh SH, Lee SR, Choi JY, Choi YS, Kim SH, Yoon HC, Nelson G. Detection of Dental Caries and Cracks with Quantitative Light-Induced Fluorescence in Comparison to Radiographic and Visual Examination: A Retrospective Case Study. Sensors (Basel). 2021 Mar 3;21(5):1741. doi: 10.3390/s21051741.

    PubMed 33802443

  • Tan R, Zhu X, Chen S, Zhang J, Liu Z, Li Z, Fan H, Wang X, Yang L. Caries lesions diagnosis with deep convolutional neural network in intraoral QLF images by handheld device. BMC Oral Health. 2024 Jun 29;24(1):754. doi: 10.1186/s12903-024-04517-x.

    PubMed 38951770

  • La Rosa GRM, Pedulla E, Chapple I, Pacino SA, Polosa R. The use of quantitative light-induced fluorescence in carious lesions research: A bibliometric review. J Dent. 2024 Sep;148:105220. doi: 10.1016/j.jdent.2024.105220. Epub 2024 Jun 30.

    PubMed 38955259

Questions about this trial

What is this clinical trial studying?

A study testing Self-assembling peptide P11-4 and Fluoride varnish in people with White Spot Lesions on Smooth Surface of Tooth, run by Medical University of Warsaw at 1 site in Poland.

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 11 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 23 Jun 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 Poland. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Turska-Szybka (+48 22 116 64 24, pedodoncja@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fluorescence Loss (ΔF) of White Spot Lesions From Baseline to 12 Months Assessed by Quantitative Light-Induced Fluorescence (time frame: baseline and 12 months follow-up). 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?

On the ClinicalTrials.gov record for NCT07664046, which also lists 28 linked publications.

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 23 Jun 2026.

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