Sleep Disorder Clinical Trial
Official title:
Nocturnal Respiratory Disorders Identification and Their Influence on the Body Posture and Breathing Synchronisation in Patients With Dentofacial Dysgnathia
Verified date | May 2023 |
Source | Laboratoire de Biomécanique Georges Charpak |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
France | Laboratoire de biomécanique Georges CHarpak | Paris |
Lead Sponsor | Collaborator |
---|---|
Laboratoire de Biomécanique Georges Charpak |
France,
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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