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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03532828
Other study ID # Dysmorphie / SAS
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 9, 2018
Est. completion date December 31, 2023

Study information

Verified date May 2023
Source Laboratoire de Biomécanique Georges Charpak
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The role of head posture has been demonstrated in patient with dentofacial deformities. However, the relationship between body posture and jaw disorders is unclear. Moreover, patients with obstructive sleep apnea have the same anatomical abnormalities than patients with dentofacial deformities. The aim of this study is to evaluate, firstly, nocturnal sleeping disorders among patients with jaw disorders. Secondly, the investigators aim to evaluate the interaction between body posture, breathing and dentofacial deformities. A polygraphy will be performed on patient with dentofacial deformities before and after correcting jaw surgery. A postural evaluation will be done using EOS imaging system and a force plate


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - patient in orthodontic preparation for a surgical treatment, - age > 16 years Exclusion Criteria: - postural disorder (scoliosis, history of spine surgery), - pregnancy or breastfeeding, - patients under guardianship

Study Design


Intervention

Other:
polysomnography
Patients will have a polygraphy, a postural evaluation including Vicon system, EOS imaging, ang a force platform

Locations

Country Name City State
France Laboratoire de biomécanique Georges CHarpak Paris

Sponsors (1)

Lead Sponsor Collaborator
Laboratoire de Biomécanique Georges Charpak

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 2D displacement range of the pressure center Pressure center is recorded with force plates 1month before and 1 year after orthognathic surgery Baseline, 1 year
Secondary Change in EOS criteria description Criteria: pelvic tilt, cervical lordosis, C7 sagittal vertical axis, T1 slope thoracic kyphosis, lumbar lordosis , pelvic incidence, sacral slope. 1month before and 1 year after orthognathic surgery Baseline, 1 year
Secondary Change Stabilometric criteria description 2D displacement of the pressure center according to the anteroposterior axis, the lateral axis. 2D displacement speed. 1month before and 1 year after orthognathic surgery Baseline, 1 year
Secondary Change in Cephalometric analysis Lateral cephalograms are recorded before and after surgery Baseline, 1 year
Secondary Change Polygraphy criteria description Apnea-hypopnea index, oxygen saturation , before and after orthognathic surgery Baseline, 1 year
Secondary Change in Dentofacial deformities description Clinical evaluation before and after surgery Baseline, 1 year
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