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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Fatih Çelik

    Konya, 42030

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05452252
Study groupRoleWhat they receive
study groupadolescents with idiopathic scoliosis
Receives: Diagnostic Test: functional mandibular evaluation
control grouphealthy individuals
Receives: Diagnostic Test: functional mandibular evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mandibular protrusion

    mandibular position change due to scoliosis

    Measured: 1 day

Secondary outcomes (1)
  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.

  1. First posted11 Jul 2022
  2. Study start1 Mar 2022
  3. Primary completion15 Jun 2022
  4. Study completion30 Jun 2022

Resources

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
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

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.

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