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临床试验/NCT07799233
NCT07799233已完成不适用

Dental-Oral and Craniofacial Characteristics of Hereditary Spastic Paraplegia: A Preliminary Study

University of Barcelona1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
ANB, SNA, and SNB angles

研究概览

简要总结

This study aims to analyze the oral and craniofacial characteristics associated with Hereditary Spastic Paraplegia (HSP) using non-invasive complementary diagnostic tests, with the hypotesis that there is a characteristic phenotype of PEF that specifically affects the stomatognathic system.

This is a preliminary observational, cross-sectional, and exploratory study. The study population includes 25 individuals with HSP and 25 control individuals with a similar age range. Functional clinical examination, intraoral scanning, panoramic radiography, and lateral cephalometric radiography were used to assess functional variables, periodontal alterations, intra- and interarch relationships, and cephalometric variables according to the Ricketts and Steiner analyses. Posterior cervical soft tissue thickness was also evaluated. Statistical analysis included between-group comparisons, effect size measures, logistic regression, and ROC analysis to determine the discriminative capacity of the studied variables.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of HSP.
  • Caucasian ethnicity.

排除标准

  • Patients with HSP who have undergone orthognathic surgery or orthodontic, orthopedic, or functional treatment.

研究组 & 干预措施

Patients Diagnosed with Hereditary Spastic Paraplegia

Patients with Hereditary Spastic Paraplegia who haven't undergone orthognathic surgery or orthodontic, orthopedic, or functional treatment.

Patients Non Diagnosed with Hereditary Spastic Paraplegia

Patients Non Diagnosed with Hereditary Spastic Paraplegia who hadn't undergone orthognathic surgery or orthodontic, orthopedic, or functional treatment

结局指标

主要结局

ANB, SNA, and SNB angles

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Measurements of the ANB, SNA, and SNB angles obtained from lateral cephalograms. These measurements were used to assess the sagittal relationship between the maxilla and the mandible relative to the cranial base and to evaluate their correlation with the presence of PEF.

Position and inclination of the upper and lower incisors

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Measurements of the position and inclination of the upper and lower incisors obtained from lateral cephalograms. These measurements were used to assess sagittal protrusion, retrusion, and incisor inclination, and to evaluate their correlation with the presence of PEF.

Facial convexity and lower facial height

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Measurements of facial convexity and lower facial height obtained from lateral cephalograms. These measurements were used to assess the sagittal and vertical relationships between the maxilla and the mandible and to evaluate their correlation with the presence of PEF.

Facial depth, facial axis, and maxillary depth

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Measurements of facial depth, facial axis, and maxillary depth obtained from lateral cephalograms. These measurements were used to assess the sagittal and vertical positions of the maxilla and mandible relative to the cranial base and to evaluate their correlation with the presence of PEF.

Cranial deflection, anterior cranial length, and mandibular body length

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Measurements of cranial deflection, anterior cranial length, and mandibular body length obtained from lateral cephalograms. These measurements were used to characterize craniofacial skeletal morphology and to evaluate their correlation with the presence of PEF.

Assessment of congenital dental anomalies

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

To evaluate the correlation between congenital dental anomalies involving tooth number, position, morphology, and other developmental alterations identified on panoramic radiographs and the presence of PEF.

Assessment of caries experience (DMFT index)

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

To evaluate the correlation between caries experience, assessed using the DMFT (Decayed, Missing, and Filled Teeth) index from panoramic radiographs and anamnesis, and the presence of PEF.

Overjet and overbite

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Measurements of overjet and overbite obtained from intraoral digital scans. These measurements were used to assess the sagittal and vertical relationships between the upper and lower incisors and to evaluate their correlation with the presence of PEF.

Molar and canine occlusal relationships

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Assessment of molar and canine occlusal relationships using intraoral digital scans. These measurements were used to evaluate occlusal relationships and to assess their correlation with the presence of PEF.

Transverse occlusal discrepancies

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Assessment of transverse occlusal discrepancies using intraoral digital scans. These measurements were used to evaluate transverse occlusal relationships and to assess their correlation with the presence of PEF.

Dental crowding

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Assessment of dental crowding using intraoral digital scans. These measurements were used to evaluate dental arch space discrepancies and to assess their correlation with the presence of PEF.

Congenital dental anomalies

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Assessment of congenital dental anomalies affecting tooth size, shape, structure, and other developmental characteristics using intraoral digital scans. These findings were used to evaluate the presence of developmental dental anomalies and to assess their correlation with the presence of PEF.

History of upper airway surgery

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Assessment of a history of upper airway surgery based on medical history (anamnesis). This information was used to evaluate its correlation with the presence of PEF.

Nocturnal snoring

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Assessment of nocturnal snoring based on medical history (anamnesis). This information was used to evaluate its correlation with the presence of PEF.

Nostril characteristics, swallowing pattern, and tongue mobility

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Assessment of nostril characteristics, swallowing pattern, and tongue mobility based on functional clinical examination. These findings were used to evaluate their correlation with the presence of PEF.

Breathing mode

时间窗: Single assessment performed during one visit, with no follow-up. In the study group, measurements were obtained within a maximum of 6 months from study enrollment. In the control group, measurements were obtained up to 10 years retrospectively.

Assessment of breathing mode (nasal, oral, or mixed) based on medical history (anamnesis) and functional clinical examination. This assessment was used to evaluate its correlation with the presence of PEF.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aina Chaparro-Arimon

Dentist

University of Barcelona

研究点 (1)

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