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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
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.
University Clinical Center of the Medical University of Warsaw, Department of Pediatric Dentistry
Warsaw, Masovian Voivodeship, Poland
RECRUITINGChange 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.
Time frame: 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.
Time frame: from baseline to the 12-month follow-up
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Time frame: 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
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.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
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.
Time frame: Baseline through 12 months
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