Scoliosis IdiopathicNCT05452252
Mandibular Evaluation and Facial Analysis In Adolescents With Idiopathic Scoliosis
An observational study of Scoliosis Idiopathic, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Fifty-eight participants with AIS and 45 healthy controls were included in the study. Active mandibular movements including depression, protrusion, and left-right deviation were assessed with a ruler. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- functional mandibular evaluation
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Jun 2022
- How long will I take part?
- 1 Day
- 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 10 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: 103 adolescents, 58 of them with idiopathic scoliosis and 45 of them healthy, were included in the study.
Who may be able to join
- 10-18 years old patients
- Cobb's angle of above 10°
- Age-matched healthy group of girls
Who cannot join
- congenital scoliosis
- spinal deformity
- undergone surgical correction of the spine
- tumor
- rheumatological disease
- neuromuscular disease
Show all 11Show fewer
- cardiovascular disease
- pulmonary disease
- renal disease
- facial surgery
- dental treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Mandibular Evaluation and Anthropometric Facial Analysis In Relation With Neck Profile In Adolescents With İdiopathic Scoliosis
Fifty-eight participants with AIS and 45 healthy controls were included in the study. Active mandibular movements including depression, protrusion, and left-right deviation were assessed with a ruler. Facial anthropometry was measured on facial shape on photograph, and phenotype and asymmetry were determined from the acquired anthropometric facial data. Neck mobility was evaluated in movements of flexion, extension, right-left lateral flexion, and right-left rotation using a standard flexible tape. The Fremantle Neck Awareness Questionnaire was used to assess neck awareness. Neck pain in the previous week was measured with a Visual Analog Scale.
Read the detailed description
Functional evaluation of the mandible was performed by measuring active mandibular movements (Fig 1). For mandibular depression, participants were asked to open their mouths as much as they could without pain. The distance between central incisors of the mandibular row of teeth and the maxillary row of the obturator was recorded. For mandible protrusion, they pushed their lower jaws forward as far as they could and the distance between the upper and lower jaws were recorded. For mandibular deviation, participants pushed their lower jaws first left and then right, and lateral mandibular excursions were measured from upper incisal midline to lower midline. All measurements were performed with the help of a 20-cm ruler and recorded in cm 16.
Facial anthropometry was measured on photograph. A digital camera mounted on a tripod at 110 centimeters in height and a distance of 100 centimeters was used to take photographs 17. Participants' position was standardized on a previously marked cross on the floor. Those who wear glasses were asked to remove the glasses, and the participants with long hair were asked to tie their hair from the top. They were asked to assume a relaxed standing position when the photographs were taken. A small white square sticker 2 cm × 2 cm was placed on the forehead and on the flat surfaces of the right and left cheeks, with the camera lens perpendicular to the square. The purpose of the sticker was to be able to express linear measurements as centimeters rather than pixels while measuring the 3 sides of facial anthropometric landmarks using the Image J program 18. All participants were photographed at front and right and left sides. The measured anthropometric variables were as follows: physiognomic face height, morphological face height, lower face height, face width, mandible width, right upper facial depth, left upper facial depth, right lower facial depth, left lower facial depth, right midfacial depth, left midfacial depth, biocular width, cheek width (distance between inferior insertion of ear), and mouth width. Landmarks are shown and measured variables are defined in Fig 2 19,20. Face golden ratio was used to determine face shape and facial index was used for face phenotype. Face golden ratio was the ratio of physiognomic facial height to the face width, and facial index was the ratio of morphological face height and maximum face width.
- Conditions
- Scoliosis Idiopathic
- Being tested
- functional mandibular evaluation
- Keywords
- Scoliosis, Temporomandibular Joint, Facial Asymmetry, Neck
- Medical subject headings
- Scoliosis, Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional mandibular evaluationDiagnostic test
Also called anthropometric facial analysis
Active mandibular movements including depression, protrusion, and left-right deviation, facial anthropometry was measured on facial shape on photograph, and phenotype and asymmetry
| Study group | Role | What they receive |
|---|---|---|
| study group | adolescents with idiopathic scoliosis Receives: Diagnostic Test: functional mandibular evaluation | |
| control group | healthy individuals Receives: Diagnostic Test: functional mandibular evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mandibular protrusion
mandibular position change due to scoliosis
Measured: 1 day
Secondary outcomes (1)
facial asymmetry
face asymmetry due to scoliosis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Mar 2022
- Primary completion15 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Çelik, Hacettepe University
- Investigators
- fatih çelik, MSc, Study director, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452252
- Sponsor's protocol ID
- GO20/694
- Status last verified
- Feb 2024
- First submitted
- 6 Jul 2022
- Last updated
- 29 Feb 2024
- 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Mandibular Evaluation and Anthropometric Facial Analysis In Relation With Neck Profile In Adolescents With İdiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05452252
- Acronym / sponsor ID
- GO20/694
- Conditions
- Scoliosis Idiopathic
- Keywords
- Scoliosis, Temporomandibular Joint, Facial Asymmetry, Neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Jul 2022 (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.
Fifty-eight participants with AIS and 45 healthy controls were included in the study. Active mandibular movements including depression, protrusion, and left-right deviation were assessed with a ruler. Facial anthropometry was measured on facial shape on photograph, and phenotype and asymmetry were determined from the acquired anthropometric facial data. Neck mobility was evaluated in movements of flexion, extension, right-left lateral flexion, and right-left rotation using a standard flexible tape. The Fremantle Neck Awareness Questionnaire was used to assess neck awareness. Neck pain in the previous week was measured with a Visual Analog Scale.
Detailed description
Functional evaluation of the mandible was performed by measuring active mandibular movements (Fig 1). For mandibular depression, participants were asked to open their mouths as much as they could without pain. The distance between central incisors of the mandibular row of teeth and the maxillary row of the obturator was recorded. For mandible protrusion, they pushed their lower jaws forward as far as they could and the distance between the upper and lower jaws were recorded. For mandibular deviation, participants pushed their lower jaws first left and then right, and lateral mandibular excursions were measured from upper incisal midline to lower midline. All measurements were performed with the help of a 20-cm ruler and recorded in cm 16.
Facial anthropometry was measured on photograph. A digital camera mounted on a tripod at 110 centimeters in height and a distance of 100 centimeters was used to take photographs 17. Participants' position was standardized on a previously marked cross on the floor. Those who wear glasses were asked to remove the glasses, and the participants with long hair were asked to tie their hair from the top. They were asked to assume a relaxed standing position when the photographs were taken. A small white square sticker 2 cm × 2 cm was placed on the forehead and on the flat surfaces of the right and left cheeks, with the camera lens perpendicular to the square. The purpose of the sticker was to be able to express linear measurements as centimeters rather than pixels while measuring the 3 sides of facial anthropometric landmarks using the Image J program 18. All participants were photographed at front and right and left sides. The measured anthropometric variables were as follows: physiognomic face height, morphological face height, lower face height, face width, mandible width, right upper facial depth, left upper facial depth, right lower facial depth, left lower facial depth, right midfacial depth, left midfacial depth, biocular width, cheek width (distance between inferior insertion of ear), and mouth width. Landmarks are shown and measured variables are defined in Fig 2 19,20. Face golden ratio was used to determine face shape and facial index was used for face phenotype. Face golden ratio was the ratio of physiognomic facial height to the face width, and facial index was the ratio of morphological face height and maximum face width.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: functional mandibular evaluationadolescents with idiopathic scoliosis |
| control group | – | Diagnostic Test: functional mandibular evaluationhealthy individuals |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 103 adolescents, 58 of them with idiopathic scoliosis and 45 of them healthy, were included in the study.
Key inclusion criteria (3 listed)
- 10-18 years old patients
- Cobb's angle of above 10°
- Age-matched healthy group of girls
Key exclusion criteria (11 listed)
- congenital scoliosis
- spinal deformity
- undergone surgical correction of the spine
- tumor
- rheumatological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional mandibular evaluationAlso: anthropometric facial analysisActive mandibular movements including depression, protrusion, and left-right deviation, facial anthropometry was measured on facial shape on photograph, and phenotype and asymmetry | Diagnostic test | control group, study group |
Primary outcome
mandibular protrusion
Time frame: 1 day
mandibular position change due to scoliosis
1 secondary outcome
facial asymmetry
Time frame: 1 day
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 29 Feb 2024.
- 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.
fatih çelik, MSc study director
PhD student
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 Scoliosis Idiopathic, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 11 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 29 Feb 2024. 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 Turkey (Türkiye). 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?
mandibular protrusion (time frame: 1 day). 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 29 Feb 2024.