NCT05411770

Brief Summary

This study was planned to examine the relationship between the stomatognathic system, spine posture and pelvis symmetry. 91 healthy adolescence were included in the study. For stomatognathic system, temporomandibular range of motion with millimeter ruler, cervical joint range of motion and craniovertebral angle measurement with goniometer, tragus-wall distance measurement with tape measure, kyphosis and lordosis angle measurement with Baseline Bubble Inclinometer®, trunk rotation angle scoliometer for scoliosis, lower extremity length measurements for pelvis symmetry were made using a tape measure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
Last Updated

June 9, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

May 31, 2022

Last Update Submit

June 6, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • Thoracic kyphosis and lumbar lordosis angle assessment

    Thoracic kyphosis and lumbar lordosis angle assessment was performed with the reliable Baseline Bubble Inclinometer®.

    12 Weeks

  • Temporomandibular range of motion

    TMJ range of motion, maximum mouth opening amount (MAAM), right and left lateral movements of the mandible (laterotrusion), anterior movement of the mandible (protrusion), and backward movement of the mandible (retrusion) were measured with a millimetric ruler, while the adolescent was seated on a chair and recorded in mm.

    12 Weeks

  • Measuring the cervical joint range of motion

    Cervical joint flexion, extension, lateral flexion and rotation ranges of motion were measured with a universal goniometer while the adolescent was sitting in a chair.

    12 Weeks

  • Craniovertebral angle measurement

    Head posture of the adolescent was evaluated by craniovertebral angle (CVA) method. Adolescents sat on a chair with back support in an upright position and turned sideways to the worker. The pivot point was accepted as the seventh cervical vertebra, and the angle between the head (tragus) and the horizontal plane was measured with a goniometer and recorded in degrees.

    12 Weeks

  • Tragus-to-wall distance measurement

    Tragus-to-wall distance was measured using a tape measure and recorded in cm.

    12 Weeks

  • Scoliosis angle assessment

    Scoliosis angle assessment was done with a scoliometer.

    12 Weeks

Interventions

Thoracic kyphosis and lumbar lordosis angle assessment was performed with the reliable Baseline Bubble Inclinometer®.

TMJ range of motion, maximum mouth opening amount (MAAM), right and left lateral movements of the mandible (laterotrusion), anterior movement of the mandible (protrusion), and backward movement of the mandible (retrusion) were measured with a millimetric ruler, while the adolescent was seated on a chair.

Cervical joint flexion, extension, lateral flexion and rotation ranges of motion were measured with a universal goniometer while the adolescent was sitting in a chair.

Head posture of the adolescent was evaluated by craniovertebral angle (CVA) method. Adolescents sat on a chair with back support in an upright position and turned sideways to the worker. The pivot point was accepted as the seventh cervical vertebra, and the angle between the head (tragus) and the horizontal plane was measured with a goniometer and recorded in degrees.

Tragus-to-wall distance was measured using a tape measure and recorded in cm.

Scoliosis angle assessment was done with a scoliometer.

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adolescent individuals aged 10-18 years were included in the study.

You may qualify if:

  • No known neurological, rheumatological, musculoskeletal problems
  • Has no visual or hearing impairment
  • Ability to adapt to the parameters to be applied in the study
  • Ability to perform tests to be applied
  • Consists of voluntary adolescent individuals whose families gave permission to participate in the study.

You may not qualify if:

  • Receiving joint sounds in the form of clicks or crepitations from the TMJ during mouth opening and closing or chewing
  • Passion and tenderness in the TMJ on palpation
  • Having a tumor Having received orthodontic treatment in the last 3 years
  • Having a history of head, neck and maxillofacial surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko University

Gaziantep, Şehitkamil, 27620, Turkey (Türkiye)

Location

Study Officials

  • Emine Betül Demirkapi, MSc

    Sanko University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 9, 2022

Study Start

July 30, 2020

Primary Completion

March 30, 2021

Study Completion

July 30, 2021

Last Updated

June 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations