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Background/objectives <p>Clear aligner attachments increase the risk of white spot lesions (WSL), with a 35.5% incidence in adolescents. The number of anterior attachments is an independent risk factor (OR = 2.192). Despite 17&#xa0;million patients treated worldwide, no study has quantitatively assessed demineralization around attachment margins. To compare the effectiveness of CPP-ACP, nano-hydroxyapatite (nHAp), and fluoride varnish versus a control for attachment-associated demineralization using DIAGNOdent monitoring.</p> Methods <p>This prospective controlled clinical trial evaluated 52 patients; 45 were enrolled, and 40 completed after five pre-baseline withdrawals. Participants were allocated to four groups (<i>n</i> = 10 each): Group A (control, fluoride toothpaste), Group B (CPP-ACP daily), Group C (nHAp professional + home gel), and Group D (fluoride varnish quarterly). DIAGNOdent measurements were taken around attachments at baseline, 1, 3, and 6 months. Linear mixed-effects models analyzed group differences (<i>p</i> &lt; 0.05).</p> Results <p>All 40 participants completed the 6-month study (100% retention). Baseline values were comparable (<i>p</i> = 0.48). Mean DIAGNOdent changes at 6 months were: Control + 4.35 [95%CI: 3.77–4.93], CPP-ACP − 4.02 [− 4.47 to − 3.56], nHAp − 5.36 [− 5.99 to − 4.72], Fluoride − 4.45 [− 4.78 to − 4.11]. The main group effect was significant (<i>p</i> &lt; 0.001; η²<i>p</i> = 0.974). All treatments outperformed the control (<i>p</i> &lt; 0.001). nHAp showed the greatest reduction, superior to CPP-ACP (<i>p</i> &lt; 0.001) and fluoride (<i>p</i> = 0.019). Fluoride exhibited a biphasic pattern.</p> Conclusions <p>All remineralization protocols significantly reduced demineralization versus control, with nHAp demonstrating the highest efficacy. Early preventive intervention and regular monitoring are recommended in attachment-bearing patients. Larger randomized trials are warranted.</p> Trial registration <p>ClinicalTrials.gov NCT07229105. Registered 13 November 2025. Retrospectively registered.</p>

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Comparative effectiveness of remineralization agents on attachment-associated enamel demineralization in clear aligner patients: A 6-Month DIAGNOdent-Based controlled clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月11日

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  • Hasan Yasin Ünal,
  • Banu Kılıç,
  • Evrim Eliguzeloglu Dalkilic

摘要

Background/objectives

Clear aligner attachments increase the risk of white spot lesions (WSL), with a 35.5% incidence in adolescents. The number of anterior attachments is an independent risk factor (OR = 2.192). Despite 17 million patients treated worldwide, no study has quantitatively assessed demineralization around attachment margins. To compare the effectiveness of CPP-ACP, nano-hydroxyapatite (nHAp), and fluoride varnish versus a control for attachment-associated demineralization using DIAGNOdent monitoring.

Methods

This prospective controlled clinical trial evaluated 52 patients; 45 were enrolled, and 40 completed after five pre-baseline withdrawals. Participants were allocated to four groups (n = 10 each): Group A (control, fluoride toothpaste), Group B (CPP-ACP daily), Group C (nHAp professional + home gel), and Group D (fluoride varnish quarterly). DIAGNOdent measurements were taken around attachments at baseline, 1, 3, and 6 months. Linear mixed-effects models analyzed group differences (p < 0.05).

Results

All 40 participants completed the 6-month study (100% retention). Baseline values were comparable (p = 0.48). Mean DIAGNOdent changes at 6 months were: Control + 4.35 [95%CI: 3.77–4.93], CPP-ACP − 4.02 [− 4.47 to − 3.56], nHAp − 5.36 [− 5.99 to − 4.72], Fluoride − 4.45 [− 4.78 to − 4.11]. The main group effect was significant (p < 0.001; η²p = 0.974). All treatments outperformed the control (p < 0.001). nHAp showed the greatest reduction, superior to CPP-ACP (p < 0.001) and fluoride (p = 0.019). Fluoride exhibited a biphasic pattern.

Conclusions

All remineralization protocols significantly reduced demineralization versus control, with nHAp demonstrating the highest efficacy. Early preventive intervention and regular monitoring are recommended in attachment-bearing patients. Larger randomized trials are warranted.

Trial registration

ClinicalTrials.gov NCT07229105. Registered 13 November 2025. Retrospectively registered.