MARPE 治疗非生长期患者时有无微骨穿孔对疼痛强度和气道变化的评估：一项随机临床试验。
Evaluation of pain intensity and airway changes in non-growing patients treated by MARPE with and without micro-osteoperforation: a randomized clinical trial.
机构信息
Department of Orthodontics, Faculty of Oral and Dental Medicine Dentistry, Delta University for Science and Technology, Algomhoria St, Mansaura, 35116, Egypt.
Department of Orthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
出版信息
BMC Oral Health. 2024 Nov 20;24(1):1411. doi: 10.1186/s12903-024-05196-4.
TRIAL DESIGN
Parallel.
OBJECTIVES
To assess the effect of mini-screw assisted rapid palatal expansion (MARPE) with/without micro-osteoperforation (MOP) on the airway and pain intensity in non-growing patients with maxillary transverse deficiency.
METHOD
Two equal groups of twenty-four individuals aged ≥ 19 years old with maxillary transverse deficit were randomly assigned. MOP-facilitated MARPE was used to treat one group (MMG), and the other group was treated with MARPE without MOP (NMG). For airway evaluation, CBCT images were obtained 2 months before starting the palatal expansion and 3 months after finishing the expansion in 28 days. The Visual Analogue Scale (VAS) was used to measure the pain level.
RESULTS
Significant suture opening was observed in both groups. All linear measurements of the nasal cavity and volumetric measurements of the nasal passage and oropharyngeal airway increased significantly in both groups, with no significant difference between them. Moderate pain was experienced in the first two weeks of expansion in MMG (5.11 ± 0.30), while more significant pain was recorded in NMG (6.87 ± 0.40). Pain decreased significantly in the following two weeks in MMG (2.77 ± 0.39) and in NMG (5.11 ± 0.32), with a significant difference between the two groups throughout the entire duration of expansion.
CONCLUSION
Transverse maxillary deficit was successfully treated with both expansion methods, with and without MOP, with comparable skeletal effects at the nasal levels and airway volumetric improvement. So, MOP did not provide any further advantage in improving the airway volume after maxillary expansion. However, it significantly reduced pain intensity throughout the entire duration of expansion.
TRIAL REGISTRATION
The protocol registration and results system (PRS) of ClinicalTrials.gov has this RCT registered under the number NCT06502041 on 13/07/2024.
试验设计
平行。
目的
评估微型骨钉辅助快速腭扩张（MARPE）联合/不联合微骨切开术（MOP）对非生长发育期上颌横向发育不足患者气道和疼痛强度的影响。
方法
将 24 名年龄≥19 岁的上颌横向发育不足患者分为两组，每组 12 名。MOP 辅助 MARPE 用于治疗一组（MMG），另一组不进行 MOP 治疗（NMG）。使用视觉模拟量表（VAS）评估疼痛水平。在开始腭扩张前 2 个月和扩张后 3 个月（28 天）获取 CBCT 图像，评估气道。
结果
两组均观察到明显的骨缝张开。两组鼻腔的所有线性测量值和鼻腔通道及口咽气道的容积测量值均显著增加，且两组间无显著差异。在 MMG 中，扩张的前两周会出现中度疼痛（5.11±0.30），而在 NMG 中则会出现更明显的疼痛（6.87±0.40）。在 MMG 中，扩张后的接下来两周疼痛显著减轻（2.77±0.39），在 NMG 中疼痛减轻（5.11±0.32），整个扩张过程中两组间疼痛差异有统计学意义。
结论
两种扩张方法（联合和不联合 MOP）均成功治疗了上颌横向发育不足，在鼻腔水平上有相似的骨骼效果，气道容积也有改善。因此，MOP 并不能在上颌扩张后进一步改善气道容积。然而，它显著减轻了整个扩张过程中的疼痛强度。
试验注册
ClinicalTrials.gov 的方案注册和结果系统（PRS）将这项 RCT 注册号为 NCT06502041，并于 2024 年 7 月 13 日注册。
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