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NCT Number: NCT07799233

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

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.

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Key information

Conditions

Hereditary Spastic Paraplegia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Spastic Paraplegia, Hereditary

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Odontològic de la Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of HSP.
  • Caucasian ethnicity.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. ANB, SNA, and SNB angles

    Time frame: 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.

  2. Position and inclination of the upper and lower incisors

    Time frame: 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.

  3. Facial convexity and lower facial height

    Time frame: 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.

  4. Facial depth, facial axis, and maxillary depth

    Time frame: 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.

  5. Cranial deflection, anterior cranial length, and mandibular body length

    Time frame: 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.

  6. Assessment of congenital dental anomalies

    Time frame: 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.

  7. Assessment of caries experience (DMFT index)

    Time frame: 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.

  8. Overjet and overbite

    Time frame: 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.

  9. Molar and canine occlusal relationships

    Time frame: 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.

  10. Transverse occlusal discrepancies

    Time frame: 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.

  11. Dental crowding

    Time frame: 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.

  12. Congenital dental anomalies

    Time frame: 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.

  13. History of upper airway surgery

    Time frame: 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.

  14. Nocturnal snoring

    Time frame: 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.

  15. Nostril characteristics, swallowing pattern, and tongue mobility

    Time frame: 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.

  16. Breathing mode

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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