NCT05452252

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

July 6, 2022

Last Update Submit

February 28, 2024

Conditions

Keywords

ScoliosisTemporomandibular JointFacial AsymmetryNeck

Outcome Measures

Primary Outcomes (1)

  • mandibular protrusion

    mandibular position change due to scoliosis

    1 day

Secondary Outcomes (1)

  • facial asymmetry

    1 day

Study Arms (2)

study group

adolescents with idiopathic scoliosis

Diagnostic Test: functional mandibular evaluation

control group

healthy individuals

Diagnostic Test: functional mandibular evaluation

Interventions

Active mandibular movements including depression, protrusion, and left-right deviation, facial anthropometry was measured on facial shape on photograph, and phenotype and asymmetry

Also known as: anthropometric facial analysis
control groupstudy group

Eligibility Criteria

Age10 Years - 18 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly females included to study
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

103 adolescents, 58 of them with idiopathic scoliosis and 45 of them healthy, were included in the study.

You may qualify if:

  • years old patients
  • Cobb's angle of above 10°
  • Age-matched healthy group of girls

You may not qualify if:

  • congenital scoliosis
  • spinal deformity
  • undergone surgical correction of the spine
  • tumor
  • rheumatological disease
  • neuromuscular disease
  • cardiovascular disease
  • pulmonary disease
  • renal disease
  • facial surgery
  • dental treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Çelik

Konya, 42030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ScoliosisFacial Asymmetry

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • fatih çelik, MSc

    PhD student

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD(s)

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 11, 2022

Study Start

March 1, 2022

Primary Completion

June 15, 2022

Study Completion

June 30, 2022

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations