Journal of dentistry · 2025
Clinical evaluation of the remineralizing potential of biomimetic scaffolds on enamel white spot lesions: A 12-month randomized controlled trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Soliman Eman M, Abdelfattah Wegdan M, Mohamed Doaa R, Nagui Dina A, Holiel Ahmed A
Аннотация
OBJECTIVES: To clinically evaluate the effectiveness of phosphorylated nano chitosan (Pchi-ACP), a novel biomimetic scaffold, and self-assembling peptide P11-4 (SAP-P11-4) in treating white spot lesions (WSLs) compared to a conventional remineralizing agent.
METHODS: Thirty-three patients with 101 WSL-affected teeth, either post-orthodontic or early enamel caries, were randomly allocated to Pchi-ACP, SAP-P11-4, or casein phosphopeptide-amorphous calcium phosphate (CPP-ACP). Materials were professionally applied twice weekly for 1.5 months. Assessments were performed at baseline (T0), immediately after the first in-office application (T1), six weeks after the final application (T2), and at 1, 3, 6, 9, and 12 months (T3-T7) using ICDAS scoring, computer-assisted surface area analysis of standardized photographs, and DIAGNOdent measurements. All participants received standardized oral hygiene instructions. Generalized linear mixed models (GLMMs) were applied to account for repeated measures and clustering, with treatment group, time, and their interaction as fixed effects (p < 0.05).
RESULTS: All groups showed significant improvements in ICDAS and DIAGNOdent values over 12 months (p < 0.05). Pchi-ACP achieved the greatest improvement, reducing median ICDAS scores (0.00 [1.00]), followed by SAP-P11-4 (1.00 [2.00]) and CPP-ACP (2.00 [1.00]) (p = 0.004-0.046). The WSL surface area was reduced to 1.14 [1.93] of the tooth surfaces for Pchi-ACP, significantly smaller than 6.39 [3.54] for SAP-P11-4 and 20.41 [26.85] for CPP-ACP (p1 < 0.001, p2 < 0.001, p3 = 0.0004). GLMM analysis confirmed a significant time effect and group-by-time interaction, validating the superior and sustained performance of Pchi-ACP over 12 months. Pairwise comparisons confirmed Pchi-ACP's superiority at all time points.
CONCLUSIONS: Pchi-ACP demonstrated superior clinical effectiveness in remineralizing early enamel lesions compared to SAP-P11-4 and CPP-ACP, supporting its potential as a promising preventive and regenerative treatment option.
CLINICAL SIGNIFICANCE: Pchi-ACP represents a valuable non-invasive treatment for WSLs, enabling effective enamel repair through a biomimetic approach.
TRIAL REGISTRATION: PACTR201901866476410; ClinicalTrials.gov ID NCT05584878.
METHODS: Thirty-three patients with 101 WSL-affected teeth, either post-orthodontic or early enamel caries, were randomly allocated to Pchi-ACP, SAP-P11-4, or casein phosphopeptide-amorphous calcium phosphate (CPP-ACP). Materials were professionally applied twice weekly for 1.5 months. Assessments were performed at baseline (T0), immediately after the first in-office application (T1), six weeks after the final application (T2), and at 1, 3, 6, 9, and 12 months (T3-T7) using ICDAS scoring, computer-assisted surface area analysis of standardized photographs, and DIAGNOdent measurements. All participants received standardized oral hygiene instructions. Generalized linear mixed models (GLMMs) were applied to account for repeated measures and clustering, with treatment group, time, and their interaction as fixed effects (p < 0.05).
RESULTS: All groups showed significant improvements in ICDAS and DIAGNOdent values over 12 months (p < 0.05). Pchi-ACP achieved the greatest improvement, reducing median ICDAS scores (0.00 [1.00]), followed by SAP-P11-4 (1.00 [2.00]) and CPP-ACP (2.00 [1.00]) (p = 0.004-0.046). The WSL surface area was reduced to 1.14 [1.93] of the tooth surfaces for Pchi-ACP, significantly smaller than 6.39 [3.54] for SAP-P11-4 and 20.41 [26.85] for CPP-ACP (p1 < 0.001, p2 < 0.001, p3 = 0.0004). GLMM analysis confirmed a significant time effect and group-by-time interaction, validating the superior and sustained performance of Pchi-ACP over 12 months. Pairwise comparisons confirmed Pchi-ACP's superiority at all time points.
CONCLUSIONS: Pchi-ACP demonstrated superior clinical effectiveness in remineralizing early enamel lesions compared to SAP-P11-4 and CPP-ACP, supporting its potential as a promising preventive and regenerative treatment option.
CLINICAL SIGNIFICANCE: Pchi-ACP represents a valuable non-invasive treatment for WSLs, enabling effective enamel repair through a biomimetic approach.
TRIAL REGISTRATION: PACTR201901866476410; ClinicalTrials.gov ID NCT05584878.