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Background <p>Maxillary molar distalization is one of the standard non-extraction strategies for correcting Class II malocclusion. However, conventional modalities are frequently hindered by profound compliance dependence, inadvertent anchorage loss, and the necessity for invasive surgical interventions. To address these limitations, a fully customized, non-invasive, intraorally cemented individual distalizer (ID) was engineered. The clinical efficiency of the ID was compared with that of the cervical headgear (CHG), and a finite element analysis (FEA) was conducted to investigate the differences in mechanical mechanisms.</p> Methods <p>Fifteen patients (24 molars) treated with the ID and 13 patients (26 molars) treated with CHG were enrolled. Molar and incisor three-dimensional movements were measured on superimposed digital models using the palatal rugae as a reference. Treatment duration and monthly distalization rates were calculated. FEA was conducted on a representative patient to simulate the stress distribution and displacement patterns under loading conditions of 200&#xa0;g (ID) and 450&#xa0;g (CHG). Stabilized inverse probability weighting (SIPW) was applied for potential baseline imbalances. A generalized linear mixed model (GLMM) was used to analyze the data, accounting for the clustering of bilateral molars. The significance level was set at 5% (ɑ=0.05).</p> Results <p>The distalization duration of the ID group (64.51 days, 95%CI [53.25, 75.77]) was significantly shorter than that of the CHG group (181.32 days, 95%CI [158.81, 203.83]) with similar distalization distance (<i>P</i> &lt; 0.001). The ID group (1.97&#xa0;mm/month, 95%CI [1.60, 2.34]) showed higher distalization efficiency compared with the CHG group (0.57&#xa0;mm/month, 95%CI [0.18, 0.96]; <i>P</i> &lt; 0.001). The ID group demonstrated a trend of molar intrusion (-0.03&#xa0;mm, 95%CI [−0.61, 0.55]), while the CHG group showed the opposite (0.95&#xa0;mm, 95CI [0.35, 1.56]; <i>P</i> = 0.033). Tooth movement of the ID and CHG groups in FEA corroborated these clinical findings. No significant differences were observed regarding molar inclination and torque, or anterior inclination and extrusion between the two groups.</p> Conclusions <p>The ID provides a highly efficient, compliance-independent alternative to cervical headgear, with the potential advantage of vertical molar control, making it particularly suitable for hyperdivergent patients. Nevertheless, careful monitoring of anterior anchorage is recommended during the distalization.</p> Trial registration <p>This study was registered at Chinese Clinical Trial Registry (ChiCTR2100048402) on July 6, 2021.</p>

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Efficiency and biomechanics of a novel CAD/CAM individual distalizer versus cervical headgear: a preliminary prospective cohort study and exploratory finite element analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月3日

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  • Yichen Luo,
  • Limin Fan,
  • Mao Liu,
  • Yunxi Zhu,
  • Ye Cao,
  • Xin She,
  • Luwei Liu,
  • Bin Yan

摘要

Background

Maxillary molar distalization is one of the standard non-extraction strategies for correcting Class II malocclusion. However, conventional modalities are frequently hindered by profound compliance dependence, inadvertent anchorage loss, and the necessity for invasive surgical interventions. To address these limitations, a fully customized, non-invasive, intraorally cemented individual distalizer (ID) was engineered. The clinical efficiency of the ID was compared with that of the cervical headgear (CHG), and a finite element analysis (FEA) was conducted to investigate the differences in mechanical mechanisms.

Methods

Fifteen patients (24 molars) treated with the ID and 13 patients (26 molars) treated with CHG were enrolled. Molar and incisor three-dimensional movements were measured on superimposed digital models using the palatal rugae as a reference. Treatment duration and monthly distalization rates were calculated. FEA was conducted on a representative patient to simulate the stress distribution and displacement patterns under loading conditions of 200 g (ID) and 450 g (CHG). Stabilized inverse probability weighting (SIPW) was applied for potential baseline imbalances. A generalized linear mixed model (GLMM) was used to analyze the data, accounting for the clustering of bilateral molars. The significance level was set at 5% (ɑ=0.05).

Results

The distalization duration of the ID group (64.51 days, 95%CI [53.25, 75.77]) was significantly shorter than that of the CHG group (181.32 days, 95%CI [158.81, 203.83]) with similar distalization distance (P < 0.001). The ID group (1.97 mm/month, 95%CI [1.60, 2.34]) showed higher distalization efficiency compared with the CHG group (0.57 mm/month, 95%CI [0.18, 0.96]; P < 0.001). The ID group demonstrated a trend of molar intrusion (-0.03 mm, 95%CI [−0.61, 0.55]), while the CHG group showed the opposite (0.95 mm, 95CI [0.35, 1.56]; P = 0.033). Tooth movement of the ID and CHG groups in FEA corroborated these clinical findings. No significant differences were observed regarding molar inclination and torque, or anterior inclination and extrusion between the two groups.

Conclusions

The ID provides a highly efficient, compliance-independent alternative to cervical headgear, with the potential advantage of vertical molar control, making it particularly suitable for hyperdivergent patients. Nevertheless, careful monitoring of anterior anchorage is recommended during the distalization.

Trial registration

This study was registered at Chinese Clinical Trial Registry (ChiCTR2100048402) on July 6, 2021.