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

16 czerwca 2026 zaktualizowane przez: Dorota Olczak-Kowalczyk, Medical University of Warsaw

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

75

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polska, 02-097
        • Rekrutacyjny
        • University Clinical Center of the Medical University of Warsaw, Department of Pediatric Dentistry
        • Kontakt:
          • Secretariat of the Department of Pediatric Dentistry
          • Numer telefonu: +48 22 116 64 24
          • E-mail: pedodoncja@wum.edu.pl
        • Główny śledczy:
          • Dorota Olczak-Kowalczyk, Prof.
        • Pod-śledczy:
          • Anna Turska-Szybka, Assoc. Prof.
        • Pod-śledczy:
          • Julia Sazonowa, Dr.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. Age >10 years and <18 years.
  2. 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).
  3. Tooth eligible for treatment:

    1. Vital pulp,
    2. no loss of hard dental tissues within the investigated lesion (ICDAS II) code 1 or 2 , LAA code 1, ICDAS-LAA>7;
    3. QLF score parameters consistent with demineralization without loss of tissue continuity- code 1 or 2),
    4. no history of trauma to the tooth.
  4. Systemically healthy patient.
  5. No contraindications to the use of fluoride preparations.
  6. No fixed orthodontic appliance.
  7. Written consent for participation in the study signed by the legal guardian, or by the legal guardian and the patient.

Exclusion Criteria:

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Single Application of Curodont Repair Plus Fluoride Varnish
Participants 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)
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 varnish will be applied every 3 months according to the study protocol.
Eksperymentalny: Repeated Application of Curodont Repair Plus Fluoride Varnish
Participants 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).
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 varnish will be applied every 3 months according to the study protocol.
Aktywny komparator: Fluoride Varnish Only
Participants will receive fluoride varnish application every 3 months only.
Fluoride varnish will be applied every 3 months according to the study protocol.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Fluorescence Loss (ΔF) of White Spot Lesions From Baseline to 12 Months Assessed by Quantitative Light-Induced Fluorescence
Ramy czasowe: baseline and 12 months follow-up
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.
baseline and 12 months follow-up
Change in lesion volume ΔQ of White Spot Lesions From Baseline to 12 Months Assessed by Quantitative Light-Induced Fluorescence
Ramy czasowe: from baseline to the 12-month follow-up
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.
from baseline to the 12-month follow-up

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in QLF Fluorescence Loss (ΔF) of White Spot Lesions From Baseline to Each Follow-up Visit
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Baseline, 3 months, 6 months, 9 months, and 12 months
Change in Lesion Area of White Spot Lesions From Baseline to Each Follow-up Visit
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Baseline, 3 months, 6 months, 9 months, and 12 months
Change in QLF Lesion Volume (ΔQ) of White Spot Lesions From Baseline to Each Follow-up Visit
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Baseline, 3 months, 6 months, 9 months, and 12 months
Mean ICDAS II Score From Baseline to Each Follow-up Visit
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Baseline, 3 months, 6 months, 9 months, and 12 months
Mean ICDAS-Lesion Activity Assessment Score From Baseline to Each Follow-up Visit
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Baseline, 3 months, 6 months, 9 months, and 12 months
Number of Lesions in Each Nyvad Lesion Activity Assessment Category From Baseline to Each Follow-up Visit
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Baseline, 3 months, 6 months, 9 months, and 12 months
Mean Plaque Index Score From Baseline to Each Follow-up Visit
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Baseline, 3 months, 6 months, 9 months, and 12 months
Mean Gingival Index Score From Baseline to Each Follow-up Visit
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Baseline, 3 months, 6 months, 9 months, and 12 months
Percentage of Sites With Bleeding on Probing From Baseline to Each Follow-up Visit
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, and 12 months
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
Baseline, 3 months, 6 months, 9 months, and 12 months
Mean Visual Analogue Scale Score for Patient-reported Tolerability
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, and 12 months
Patient-reported tolerability will be assessed using the Visual Analogue Scale. The scale ranges from 0 to 10, with higher scores indicating worse tolerability.
Baseline, 3 months, 6 months, 9 months, and 12 months
Number of Adverse Events Throughout the Study Period
Ramy czasowe: Baseline through 12 months
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.
Baseline through 12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Dorota Olczak-Kowalczyk, Prof., Medical University of Warsaw

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 lutego 2026

Zakończenie podstawowe (Szacowany)

31 października 2027

Ukończenie studiów (Szacowany)

14 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

10 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

23 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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