Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05452252 |
| Other study ID # |
GO20/694 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
February 2024 |
| Source |
Hacettepe University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
