Resin infiltration versus self-assembling peptide P11-4 with and without fluoride varnish for white spot lesions in children: a randomized controlled trial
Alaa M. Eldehnaa✉, Aytallah Salema, Dina Yousry El Kharadlyb, Nada A. Salemb, Sherine Badawy, Shaimaa Alrafeec
- aDepartment of Pedodontics and Oral Health , Faculty of Dental Medicine for Girls , Al-Azhar University , 11651 Cairo , Egypt
- bPediatric Dentistry and Dental Public Health Department , Faculty of Dentistry , October
- cDepartment of Operative Dentistry
- ✉Corresponding author
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Abstract
Background: Comparative clinical evidence regarding minimally invasive protocols for non-cavitated white spot lesions (WSLs) in children remains limited.This trial compared resin infiltration (RI), self-assembling peptide P11-4 monotherapy, and P11-4 with 5% sodium fluoride varnish (P11-4 + FV) over 6 months.Methods: In this multicenter, single-masked, three-arm parallel randomized controlled trial, 105 children aged 7-14 years with non-cavitated WSLs (International Caries Detection and Assessment System (ICDAS II) score 2) on both maxillary central incisors were randomized at the patient level (35 per group; 210 teeth).The primary outcome was color change (∆E), assessed using CIE L*a*b* (CIELAB) photographic analysis; secondary outcomes were visual lesion regression (ICDAS II) and lesion activity measured using DIAGNOdent.Given baseline imbalance, prespecified baseline-adjusted analyses (linear mixed-effects models, analysis of covariance (ANCOVA), and rank-based ANCOVA) informed primary inference.Significance was set at p < 0.05.Results: Two hundred teeth were analyzed per protocol.After adjusting for baseline severity, between-group differences in color change were not significant (p = 0.094).RI produced the most rapid ICDAS II improvement (score 1.32, standard deviation (SD) 0.94, post-treatment).Because DIAGNOdent readings from infiltrated surfaces are confounded by the resin optical pathway, fluorescence comparisons were restricted to non-resin arms; at 6 months, P11-4 + FV was lower (mean 1.10, SD 0.94) than P11-4 monotherapy (mean 3.79, SD 3.26; p < 0.001), which showed a significant rebound.Conclusions: No significant betweengroup difference in color outcome remained after baseline adjustment; as the trial was not powered for equivalence, this reflects a non-detected rather than proven difference.RI provided the most rapid visual improvement, whereas P11-4 + FV showed the most durable reduction in lesion-activity fluorescence.Protocol selection should follow the primary goal: rapid esthetic correction (RI) or durable lesion-activity control (P11-4 + FV).Clinical Trial Registration: ClinicalTrials.govNCT06708481 (prospectively registered, August 2024).
TL;DRRI provided the most rapid visual improvement, whereas P11-4 + FV showed the most durable reduction in lesion-activity fluorescence, whereas P11-4 + FV showed the most durable reduction in lesion-activity fluorescence. (Semantic Scholar)