White Spot Lesions on Smooth Surface of Tooth
Conditions
Keywords
Curodont Repair, SAP P11-4, Self-Assembling Peptide P11-4, Remineralisation, Quantitative Light-Induced Fluorescence, Fluoride Varnish, Pediatric Dentistry, White Spot Lesions
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.
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.
Interventions
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.
OTHERFluoride varnish
Fluoride varnish will be applied every 3 months according to the study protocol.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomized in a parallel design to one of three study groups.
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fluorescence Loss (ΔF) of White Spot Lesions From Baseline to 12 Months Assessed by Quantitative Light-Induced Fluorescence | 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. |
| Change in lesion volume ΔQ of White Spot Lesions From Baseline to 12 Months Assessed by Quantitative Light-Induced Fluorescence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Mean ICDAS II Score From Baseline to Each Follow-up Visit | 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. |
| Mean ICDAS-Lesion Activity Assessment Score From Baseline to Each Follow-up Visit | 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. |
| Number of Lesions in Each Nyvad Lesion Activity Assessment Category From Baseline to Each Follow-up Visit | 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. |
| Mean Plaque Index Score From Baseline to Each Follow-up Visit | 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. |
| Mean Gingival Index Score From Baseline to Each Follow-up Visit | 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. |
| Percentage of Sites With Bleeding on Probing From Baseline to Each Follow-up Visit | 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 |
| Mean Visual Analogue Scale Score for Patient-reported Tolerability | 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. |
| Number of Adverse Events Throughout the Study Period | 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. |
Countries
Poland
Contacts
CONTACTAnna Turska-Szybka
PRINCIPAL_INVESTIGATORDorota Olczak-Kowalczyk, Prof.
Medical University of Warsaw
Outcome results
None listed