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

NCT07664046 | Recruiting DMC

• 1 other identifier: CURODONT-WSL-2026
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

White Spot Lesions on Smooth Surface of Tooth

Keywords

Curodont Repair; SAP P11-4; Self-Assembling Peptide P11-4; Remineralisation; Quantitative Light-Induced Fluorescence; Fluoride Varnish; Pediatric Dentistry; White Spot Lesions

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

Secondary Outcomes (11)

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

  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

  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

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

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

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

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

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

Study Arms (3)

Single Application of Curodont Repair Plus Fluoride Varnish

EXPERIMENTAL

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)

Other: Self-assembling peptide P11-4; Other: Fluoride varnish

Repeated Application of Curodont Repair Plus Fluoride Varnish

EXPERIMENTAL

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).

Other: Self-assembling peptide P11-4; Other: Fluoride varnish

Fluoride Varnish Only

ACTIVE COMPARATOR

Participants will receive fluoride varnish application every 3 months only.

Other: Fluoride varnish

Interventions

Self-assembling peptide P11-4 OTHER

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.

Repeated Application of Curodont Repair Plus Fluoride Varnish; Single Application of Curodont Repair Plus Fluoride Varnish

Fluoride varnish OTHER

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

Fluoride Varnish Only; Repeated Application of Curodont Repair Plus Fluoride Varnish; Single Application of Curodont Repair Plus Fluoride Varnish

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

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

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

Related Publications (27)

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  RESULT

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• 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.

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• 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.

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• 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.

  PMID: 39316130 RESULT

• 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.

  PMID: 33802443 RESULT

• 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.

  PMID: 38951770 RESULT

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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Related Links

• QLF description

Study Officials

• Dorota Olczak-Kowalczyk, Prof.

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Turska-Szybka

CONTACT

+48 22 116 64 24; pedodoncja@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will be blinded at the pre-randomization stage. Until randomization, the participant and investigators will not know the intended group allocation.After randomization the trial becomes partially blinded for two investigators, who will be aware of the assigned group and will be responsible for delivering the intervention, visual-tactile examination and documenting adverse events. The third investigator will remain blinded throughout the study and will not have access to information on the participant's allocation. Only this investigator will be responsible for QLF assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Model Details: Participants will be randomized in a parallel design to one of three study groups.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 23, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 14, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)