Hereditary Spastic ParaplegiaNCT07799233
Dental-Oral and Craniofacial Characteristics of Hereditary Spastic Paraplegia: A Preliminary Study
An observational study of Hereditary Spastic Paraplegia, run by University of Barcelona at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hereditary Spastic Paraplegia
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2025to 30 Apr 2026
- How long will I take part?
- 50 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Members of the Catalan branch of the Spanish Hereditary Spastic Paraplegia Association.
Who may be able to join
- Confirmed diagnosis of HSP.
- Caucasian ethnicity.
Who cannot join
- Patients with HSP who have undergone orthognathic surgery or orthodontic, orthopedic, or functional treatment.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Odontològic de la Universitat de Barcelona
L'Hospitalet de Llobregat, Barcelona, 08907
About this 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.
- Conditions
- Hereditary Spastic Paraplegia
- Keywords
- Dental-Oral, Craniofacial, Dentistry, Hereditary Spastic Paraplegia
- Medical subject headings
- Spastic Paraplegia, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANB, SNA, and SNB angles
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.
Measured: 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.
Position and inclination of the upper and lower incisors
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.
Measured: 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.
Facial convexity and lower facial height
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.
Measured: 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.
Facial depth, facial axis, and maxillary depth
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.
Measured: 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.
Cranial deflection, anterior cranial length, and mandibular body length
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.
Measured: 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
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.
Measured: 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 caries experience (DMFT index)
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.
Measured: 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.
Overjet and overbite
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.
Measured: 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.
Molar and canine occlusal relationships
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.
Measured: 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.
Transverse occlusal discrepancies
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.
Measured: 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.
Dental crowding
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.
Measured: 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.
Congenital dental anomalies
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.
Measured: 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.
History of upper airway surgery
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.
Measured: 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.
Nocturnal snoring
Assessment of nocturnal snoring based on medical history (anamnesis). This information was used to evaluate its correlation with the presence of PEF.
Measured: 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.
Nostril characteristics, swallowing pattern, and tongue mobility
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.
Measured: 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.
Breathing mode
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start15 Oct 2025
- Primary completion27 Feb 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Spastic ParaplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 50 Days
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aina Chaparro-Arimon, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799233
- Sponsor's protocol ID
- 45/2025
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental-Oral and Craniofacial Characteristics of Hereditary Spastic Paraplegia: A Preliminary Study
- ClinicalTrials.gov ID
- NCT07799233
- Acronym / sponsor ID
- 45/2025
- Conditions
- Hereditary Spastic Paraplegia
- Keywords
- Dental-Oral, Craniofacial, Dentistry, Hereditary Spastic Paraplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 50 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Members of the Catalan branch of the Spanish Hereditary Spastic Paraplegia Association.
Key inclusion criteria (2 listed)
- Confirmed diagnosis of HSP.
- Caucasian ethnicity.
Key exclusion criteria (1 listed)
- Patients with HSP who have undergone orthognathic surgery or orthodontic, orthopedic, or functional treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Spastic Paraplegia, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.