The Effectiveness of the Self-Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions (WSL-Curodont)
16 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
75
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Anna Turska-Szybka
- Telefoonnummer: +48 22 116 64 24
- E-mail: pedodoncja@wum.edu.pl
Studie Locaties
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 02-097
- Werving
- University Clinical Center of the Medical University of Warsaw, Department of Pediatric Dentistry
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Contact:
- Secretariat of the Department of Pediatric Dentistry
- Telefoonnummer: +48 22 116 64 24
- E-mail: pedodoncja@wum.edu.pl
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Hoofdonderzoeker:
- Dorota Olczak-Kowalczyk, Prof.
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Onderonderzoeker:
- Anna Turska-Szybka, Assoc. Prof.
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Onderonderzoeker:
- Julia Sazonowa, Dr.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- 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),
- 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.
Exclusion Criteria:
- 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.
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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)
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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.
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Experimenteel: 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).
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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.
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Actieve vergelijker: Fluoride Varnish Only
Participants will receive fluoride varnish application every 3 months only.
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Fluoride varnish will be applied every 3 months according to the study protocol.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Fluorescence Loss (ΔF) of White Spot Lesions From Baseline to 12 Months Assessed by Quantitative Light-Induced Fluorescence
Tijdsspanne: baseline and 12 months follow-up
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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.
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baseline and 12 months follow-up
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Change in lesion volume ΔQ of White Spot Lesions From Baseline to 12 Months Assessed by Quantitative Light-Induced Fluorescence
Tijdsspanne: from baseline to the 12-month follow-up
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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.
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from baseline to the 12-month follow-up
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in QLF Fluorescence Loss (ΔF) of White Spot Lesions From Baseline to Each Follow-up Visit
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months
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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.
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Baseline, 3 months, 6 months, 9 months, and 12 months
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Change in Lesion Area of White Spot Lesions From Baseline to Each Follow-up Visit
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months
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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.
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Baseline, 3 months, 6 months, 9 months, and 12 months
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Change in QLF Lesion Volume (ΔQ) of White Spot Lesions From Baseline to Each Follow-up Visit
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months
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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.
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Baseline, 3 months, 6 months, 9 months, and 12 months
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Mean ICDAS II Score From Baseline to Each Follow-up Visit
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months
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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.
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Baseline, 3 months, 6 months, 9 months, and 12 months
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Mean ICDAS-Lesion Activity Assessment Score From Baseline to Each Follow-up Visit
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months
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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.
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Baseline, 3 months, 6 months, 9 months, and 12 months
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Number of Lesions in Each Nyvad Lesion Activity Assessment Category From Baseline to Each Follow-up Visit
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months
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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.
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Baseline, 3 months, 6 months, 9 months, and 12 months
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Mean Plaque Index Score From Baseline to Each Follow-up Visit
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months
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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.
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Baseline, 3 months, 6 months, 9 months, and 12 months
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Mean Gingival Index Score From Baseline to Each Follow-up Visit
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months
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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.
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Baseline, 3 months, 6 months, 9 months, and 12 months
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Percentage of Sites With Bleeding on Probing From Baseline to Each Follow-up Visit
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months
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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
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Baseline, 3 months, 6 months, 9 months, and 12 months
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Mean Visual Analogue Scale Score for Patient-reported Tolerability
Tijdsspanne: Baseline, 3 months, 6 months, 9 months, and 12 months
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Patient-reported tolerability will be assessed using the Visual Analogue Scale.
The scale ranges from 0 to 10, with higher scores indicating worse tolerability.
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Baseline, 3 months, 6 months, 9 months, and 12 months
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Number of Adverse Events Throughout the Study Period
Tijdsspanne: Baseline through 12 months
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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.
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Baseline through 12 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Dorota Olczak-Kowalczyk, Prof., Medical University of Warsaw
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Shaalan O, Fawzy El-Sayed K, Abouauf E. Evaluation of the remineralization potential of self-assembling peptide P11-4 with fluoride compared to fluoride varnish in the management of incipient carious lesions: a randomized controlled clinical trial. Clin Oral Investig. 2024 Jul 22;28(8):438. doi: 10.1007/s00784-024-05822-z.
- Gohar RAAEG, Ibrahim SH, Safwat OM. Evaluation of the remineralizing effect of biomimetic self-assembling peptides in post-orthodontic white spot lesions compared to fluoride-based delivery systems: randomized controlled trial. Clin Oral Investig. 2023 Feb;27(2):613-624. doi: 10.1007/s00784-022-04757-7. Epub 2022 Oct 26.
- Klimaite G, Vasiliauskas A, Grinkevicius P, Grinkeviciene D, Sapalas D. The Efficacy of Remineralizing Materials on Artificial Enamel Lesions: An In Vitro Study. Medicina (Kaunas). 2025 Mar 6;61(3):462. doi: 10.3390/medicina61030462.
- Kamal D, Hassanein H, Elkassas D, Hamza H. Complementary remineralizing effect of self-assembling peptide (P11-4) with CPP-ACPF or fluoride: An in vitro study. J Clin Exp Dent. 2020 Feb 1;12(2):e161-e168. doi: 10.4317/jced.56295. eCollection 2020 Feb.
- Kobeissi R, Badr SB, Osman E. Effectiveness of Self-assembling Peptide P11-4 Compared to Tricalcium Phosphate Fluoride Varnish in Remineralization of White Spot Lesions: A Clinical Randomized Trial. Int J Clin Pediatr Dent. 2020 Sep-Oct;13(5):451-456. doi: 10.5005/jp-journals-10005-1804.
- Atteya SM, Amer HA, Saleh SM, Safwat Y. Self-assembling peptide and nano-silver fluoride in remineralizing early enamel carious lesions: randomized controlled clinical trial. BMC Oral Health. 2023 Aug 19;23(1):577. doi: 10.1186/s12903-023-03269-4.
- Sedlakova Kondelova P, Mannaa A, Bommer C, Abdelaziz M, Daeniker L, di Bella E, Krejci I. Efficacy of P11-4 for the treatment of initial buccal caries: a randomized clinical trial. Sci Rep. 2020 Nov 19;10(1):20211. doi: 10.1038/s41598-020-77057-3.
- Doberdoli D, Bommer C, Begzati A, Haliti F, Heinzel-Gutenbrunner M, Juric H. Randomized Clinical Trial investigating Self-Assembling Peptide P11-4 for Treatment of Early Occlusal Caries. Sci Rep. 2020 Mar 6;10(1):4195. doi: 10.1038/s41598-020-60815-8.
- Guven E, Eden E, Attin R, Firinciogullari EC. Remineralization of post-orthodontic white spot lesions with a fluoride varnish and a self-assembling P 11 - 4 peptides: a prospective in-vivo-study. Clin Oral Investig. 2024 Aug 3;28(8):464. doi: 10.1007/s00784-024-05865-2.
- Babu B, Padawe D, Takate V. Remineralization Potential of Self-Assembling Peptides Versus Fluoride Agents in White Spot Lesions: A Systematic Review. Cureus. 2025 Oct 25;17(10):e95416. doi: 10.7759/cureus.95416. eCollection 2025 Oct.
- Jablonski-Momeni A, Temming T, Berthold JN, Olbrisch C, Diekmeier C, Bottenberg P, Korbmacher-Steiner H. A prospective, triple-blind, randomized controlled clinical trial evaluating the protective effect of P11-4 peptide on enamel demineralization during multibracket orthodontic treatment. BMC Oral Health. 2026 Jan 9;26(1):379. doi: 10.1186/s12903-025-07642-3.
- Shakir S, Umer F, Khalid Q, Shahzad K, Hussain U, Mohammad S, Omair H, Campobasso A, Naseem W, Khan J. Effect of Self-Assembling Peptide on White Spot Lesions in Orthodontic Patients: A Systematic Review and Meta-Analysis. Clin Exp Dent Res. 2026 Apr;12(2):e70321. doi: 10.1002/cre2.70321.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
2 februari 2026
Primaire voltooiing (Geschat)
31 oktober 2027
Studie voltooiing (Geschat)
14 december 2027
Studieregistratiedata
Eerst ingediend
10 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
16 juni 2026
Eerst geplaatst (Werkelijk)
23 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
23 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
16 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- CURODONT-WSL-2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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