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Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE

2026年10月3日 更新者：Hasan KILINÇ、Adiyaman University

Evaluation of Three-Dimensional Facial Soft Tissue Changes and Their Clinical Perceptibility Following Miniscrew-Assisted Rapid Palatal Expansion (MARPE)

This prospective, controlled observational study aims to evaluate three-dimensional (3D) facial soft tissue changes following miniscrew-assisted rapid palatal expansion (MARPE) and determine whether these changes are clinically perceptible to orthodontic specialists and patients.

A total of 55 postpubertal participants aged 16-25 years will be included: 40 patients undergoing MARPE as part of their routine orthodontic treatment and 15 control participants who will not undergo maxillary expansion. Treatment decisions will be made independently of study participation.

Facial soft tissue changes will be assessed using 3D facial scans. The MARPE group will be scanned before expansion (T0), immediately after active expansion (T1), and three months after expansion (T2). The control group will undergo two facial scans at comparable baseline and follow-up intervals.

Changes in facial regions, including the nose, paranasal area, midface, and upper lip, will be evaluated. Blinded orthodontic specialists will assess the clinical perceptibility of changes using standardized facial images, while participants will provide their own perception of facial changes through questionnaires. When available from routine clinical records, skeletal and dental expansion measurements will also be analyzed in relation to the observed soft tissue changes.

The study aims to clarify the magnitude, distribution, and clinical relevance of facial soft tissue changes associated with MARPE.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

his single-center prospective controlled observational study will investigate facial soft tissue changes associated with miniscrew-assisted rapid palatal expansion (MARPE) in postpubertal individuals.

Three-dimensional facial images will be obtained using the MetiSmile facial scanning system (Shining 3D, Hangzhou, China) under standardized conditions, including natural head position, neutral facial expression, and relaxed lips.

The MARPE group will be evaluated at three time points: before appliance activation (T0), following completion of active expansion (T1), and after a three-month retention period (T2). The control group will undergo facial scanning at baseline and at a follow-up interval corresponding to the T0-T2 observation period.

Regional soft tissue changes will be assessed in the nasal, alar base, paranasal, nasolabial, midfacial, and upper lip regions. Clinical perceptibility will be investigated through blinded orthodontic specialist assessments of standardized facial image pairs. Patient-reported perception of facial changes will also be recorded using structured questionnaires.

Where routine clinical CBCT records are available, skeletal expansion and intermolar width changes will be measured and their relationships with regional facial soft tissue changes will be investigated. No additional radiographic examinations will be performed solely for research purposes.

Comparisons between the MARPE and control groups will be used to distinguish expansion-associated facial changes from changes occurring during the observation period.

研究类型

观察性的

注册 (估计的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 土耳其（türkiye）
    • Adıyaman Province
      • Adıyaman、Adıyaman Province、土耳其（türkiye）、02040
        • Adiyaman University Faculty of Dentistry, Department of Orthodontics
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 至 25年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population will consist of 60 postpubertal orthodontic patients aged 16-25 years recruited from the Department of Orthodontics, Faculty of Dentistry, Adiyaman University, Türkiye. The MARPE group will include 40 patients undergoing clinically indicated maxillary expansion, while the control group will consist of 20 age- and skeletal maturation-matched orthodontic patients who will not receive maxillary expansion during the observation period. All participants will be prospectively followed using three-dimensional facial scans. Treatment decisions will be made independently of study participation.

描述

Inclusion Criteria:

  • Individuals aged 16-25 years.
  • Postpubertal skeletal maturation confirmed by cervical vertebral maturation (CVM) assessment using existing lateral cephalometric radiographs.
  • Patients with a clinical indication for miniscrew-assisted rapid palatal expansion (MARPE), determined independently of the study (MARPE group).
  • Orthodontic patients matched for age and skeletal maturation who will not undergo maxillary expansion during the observation period (control group).
  • Willingness to participate and provision of informed consent (and parental/legal guardian consent for participants under 18 years).

Exclusion Criteria:

  • History of previous maxillary expansion treatment.
  • Previous or planned orthognathic surgery during the observation period.
  • Facial aesthetic procedures or surgical interventions that may influence soft tissue morphology during follow-up.
  • Systemic diseases or craniofacial conditions affecting bone or soft tissue development.
  • Maxillary expansion performed in control participants during the observation period.
  • Inability to complete the required facial scans or follow-up assessments.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
MARPE Group

Participants aged 16-25 years with a clinical indication for miniscrew-assisted rapid palatal expansion (MARPE). A total of 40 participants will undergo routine MARPE treatment independently of the study. Three-dimensional facial scans will be obtained before expansion (T0), immediately after active expansion (T1), and at the third month of retention (T2).
设备：Miniscrew-Assisted Rapid Palatal Expansion (MARPE)

MARPE is performed as part of routine orthodontic treatment based on an independent clinical indication. The study does not assign or modify the treatment. Three-dimensional facial scans are obtained before expansion (T0), immediately after active expansion (T1), and at the third month of retention (T2) to evaluate facial soft tissue changes.
Control Group

Twenty age- and skeletal maturation-matched orthodontic patients who will not undergo maxillary expansion during the observation period. Routine orthodontic treatment may continue. Three-dimensional facial scans will be obtained at two time points corresponding to the baseline and three-month retention follow-up interval of the MARPE group.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Three-Dimensional Facial Soft Tissue Changes Following MARPE
大体时间：Baseline (T0), immediately after active expansion (T1), and 3 months after active expansion (T2). Control participants will be assessed at two corresponding time points.

Three-dimensional facial soft tissue changes will be evaluated using MetiSmile facial scans. Regional changes in the nasal, paranasal, midfacial, zygomatic, and upper lip areas will be quantified in millimeters (mm) by comparing baseline and follow-up scans. Changes from T0 to T2 will be compared between the MARPE and control groups. Additional changes between T0-T1 and T1-T2 will be assessed in the MARPE group.
Baseline (T0), immediately after active expansion (T1), and 3 months after active expansion (T2). Control participants will be assessed at two corresponding time points.

次要结果测量

结果测量
措施说明
大体时间
Expert Assessment of Perceived Facial Changes
大体时间：Baseline (T0) to 3 months after active expansion (T2).

Blinded orthodontic experts will evaluate paired three-dimensional facial images to assess the perceptibility and magnitude of facial changes. Assessments will include identification of the later time point, confidence level (0-10), perceived change severity (0-4), and facial regions showing the most noticeable changes.
Baseline (T0) to 3 months after active expansion (T2).

其他结果措施

结果测量
措施说明
大体时间
Patient-Reported Perception of Facial Changes
大体时间：3 months after active expansion (T2).

Participants will complete a self-assessment questionnaire to evaluate their perceived facial changes following MARPE treatment. Patient-reported perceptions will be assessed and compared with objectively measured three-dimensional facial soft tissue changes.
3 months after active expansion (T2).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Adiyaman University

调查人员

  • 首席研究员：Nihal HAMAMCI, Professor Doctor、Adiyaman University
  • 研究主任：Hasan Kılınç, research assistant、Adiyaman University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年9月29日

首先提交符合 QC 标准的

2026年9月29日

首次发布 (实际的)

2026年10月5日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月3日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • ADIYAMAN-MARPE-2026-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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