Idiopathic ScoliosisSITONCT05156359
Idiopathic Scoliosis and Orthodontic Treatment
An observational study of Idiopathic Scoliosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Scoliotic pathology remains to this day little known, on the one hand in its etiologies but also in its various implications and possible associations. One of the notable questions found in the literature is concerned with the link between idiopathic scoliosis and the stomatognathic system. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Idiopathic Scoliosis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 31 Dec 2021
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children (age ≥ 12 years) with idiopathic scoliosis confirmed by X-ray.
Who may be able to join
- Adult and child (age ≥ 12 years)
- Be carriers of idiopathic scoliosis confirmed by X-ray.
- Have reached bone maturity (Risser 4 and more)
- Adult who has not expressed, after information, the reuse of his data for the purposes of this research
- - Child and Holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research
Who cannot join
- Refusal to participate in the study
- Association with another orthopedic pathology
- Adult patients under guardianship or crater or under the protection of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Orthopédique Pédiatrique - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Scoliotic pathology remains to this day little known, on the one hand in its etiologies but also in its various implications and possible associations. One of the notable questions found in the literature is concerned with the link between idiopathic scoliosis and the stomatognathic system. This question arises from the study of the anatomy and function of its two entities.
The aim of the study is to determine the frequency of orthodontic treatment in adolescents with idiopathic scoliosis, and to compare it with that of adolescents without spinal dysmorphism.
- Conditions
- Idiopathic Scoliosis
- Keywords
- Idiopathic scoliosis, Orthodontic Treatment, spinal dysmorphism
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the frequency of wearing orthodontic treatment in idiopathic scoliosis adolescents, and compare it with that of adolescents without spinal dysmorphism.
Measured: Files analysed retrospectively from January 01, 2020 to August 31, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Dec 2020
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156359
- Sponsor's protocol ID
- 8049
- Acronym
- SITO
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Scoliosis and Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT05156359
- Acronym / sponsor ID
- SITO / 8049
- Conditions
- Idiopathic Scoliosis
- Keywords
- Idiopathic scoliosis, Orthodontic Treatment, spinal dysmorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Dec 2021 (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.
Scoliotic pathology remains to this day little known, on the one hand in its etiologies but also in its various implications and possible associations. One of the notable questions found in the literature is concerned with the link between idiopathic scoliosis and the stomatognathic system. This question arises from the study of the anatomy and function of its two entities.
The aim of the study is to determine the frequency of orthodontic treatment in adolescents with idiopathic scoliosis, and to compare it with that of adolescents without spinal dysmorphism.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children (age ≥ 12 years) with idiopathic scoliosis confirmed by X-ray.
Key inclusion criteria (5 listed)
- Adult and child (age ≥ 12 years)
- Be carriers of idiopathic scoliosis confirmed by X-ray.
- Have reached bone maturity (Risser 4 and more)
- Adult who has not expressed, after information, the reuse of his data for the purposes of this research
- - Child and Holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Association with another orthopedic pathology
- Adult patients under guardianship or crater or under the protection of justice
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
Determination of the frequency of wearing orthodontic treatment in idiopathic scoliosis adolescents, and compare it with that of adolescents without spinal dysmorphism.
Time frame: Files analysed retrospectively from January 01, 2020 to August 31, 2020 will be examined]
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 26 Jan 2022.
Related trials for Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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 Idiopathic Scoliosis, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 3 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 26 Jan 2022. 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 France. 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?
Determination of the frequency of wearing orthodontic treatment in idiopathic scoliosis adolescents, and compare it with that of adolescents without spinal dysmorphism. (time frame: Files analysed retrospectively from January 01, 2020 to August 31, 2020 will be examined]). 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 26 Jan 2022.