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. 2025 Jul 27;11(1):70.
doi: 10.1038/s41405-025-00353-5.

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

Bardis Salah Abd Elaziz  1   2 , Dina Hamdy  3 , Mona Galal  4 , Nagwa Mohammed Ali Khattab  3
Affiliations

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

Bardis Salah Abd Elaziz et al. BDJ Open. .

Abstract

Background: White spot lesions (WSLs) is a caries lesion distinguished by white opacity due to subsurface enamel demineralization. These lesions resulting from a disparity between detrimental and protective factors and can continue to demineralize if untreated. Early diagnosis and remineralization can reverse WSLs, supporting minimally invasive dental care.

Aim: To compare and assess the color of WSLs through spectrophotometer after application of Self-assembling peptide P11-4, 2% Arginine Enriched Sodium Fluoride varnish and Functionalized Tri Calcium Phosphate Fluoride varnish.

Methods: This randomized controlled triple-blind clinical trial enrolled pediatric participants (ages 8-12 years) presenting with moderate caries risk as defined by CAMBRA (Caries Management By Risk Assessment) criteria, with visible white spot lesions (WSLs) on the labial surfaces of maxillary permanent anterior teeth, classified as ICDAS scores 1 or 2. A total of 39 WSLs were incorporated into the study and randomly allocated into one of the three groups 13/each. Group I: Self-assembling peptide P11-4 varnish (study group), Group II: Arginine-enriched Sodium Fluoride varnish (study group) and Group III: Tri Calcium Phosphate Fluoride varnish (positive control group). The color change ΔE of each WSL was quantified using a spectrophotometer at the baseline. Dimensions of WSLs were assessed by digital photography, remineralizing agents were applied then patients were recalled for further applications after 3 and 6 months and for WSLs assessment after 3, 6 and 9 months.

Results: All groups demonstrated progressive color improvement over time. At 3 months, Group I showed the least improvement (ΔE = 16.39 ± 3.04), followed by Group III (14.80 ± 3.11) and Group II (14.06 ± 4.46). By 9 months, Group II achieved (ΔE = 9.37 ± 3.79), and Group III (9.15 ± 2.74) surpassing Group I (12.21 ± 3.03). so both Group II and III ultimately outperformed Group I in color correction by the study's end. Group II achieved significantly greater WSL reduction (14.98 ± 7.55%) compared to both Group I (27.93 ± 8.98%) and Group III (22.32 ± 8.61%), with no significant difference observed between Groups I and III.

Conclusions: Although all the three tested materials demonstrated an enhancement in the color and dimension of WSLs, 2% of Arginine Enriched Sodium Fluoride showed the best results followed by Functionalized Tri Calcium Phosphate Fluoride varnish, while self-assembling peptide P11-4 showed the lowest results.

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Conflict of interest statement

Competing interests: The authors declare no competing interests. The study protocol was reviewed by the Research Ethics Committee and Institutional Review Board, Faculty of Dentistry, Ain Shams University, with reference number (FDASU-Rec ID 032107). Both verbal and written consent were obtained from the participants’ caregiver following an explanation of the study’s aims and a guarantee of complete data confidentiality. All caregivers and subjects were apprised of their ability to quit from the study at any time. Additionally, subjects were requested to fill out an assent form after receiving an appropriate age-specific description of the study methodology and objectives.

Figures

Fig. 1
Fig. 1
Flowchart depicting trial recruitment, randomization, allocation, and analysis during the follow-up period in accordance to CONSORT principles.
Fig. 2
Fig. 2
Steps of WSLs % calculation.
Fig. 3
Fig. 3
Application of (Self assembling peptide P11-4).
Fig. 4
Fig. 4
Application of Arginine Enriched Sodium fluoride group.
Fig. 5
Fig. 5
Application of Clinpro White Varnish.
See this image and copyright information in PMC

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