Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients

Not Applicable

Active, not recruiting

• Conditions: Dentofacial Deformities; Sleep Disorder; Posture
• Interventions: Other: polysomnography

• Registration Number: NCT03532828
• Lead Sponsor: Laboratoire de Biomécanique Georges Charpak

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-05-21
• Study First Posted: 2018-05-22
• Primary Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Polysomnography alone	polysomnography	A polygraphy will be performed in 70 patient to search for obstructive sleep apnea
Polysomnography and postural assesment	polysomnography	A polygraphy and a postural assesment will be performed in 30 patients

Primary Outcome Measures

Name	Time	Method
Change in 2D displacement range of the pressure center	Baseline, 1 year	Pressure center is recorded with force plates 1month before and 1 year after orthognathic surgery

Secondary Outcome Measures

Name	Time	Method
Change in Dentofacial deformities description	Baseline, 1 year	Clinical evaluation before and after surgery
Change Stabilometric criteria description	Baseline, 1 year	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
Change in Cephalometric analysis	Baseline, 1 year	Lateral cephalograms are recorded before and after surgery
Change in EOS criteria description	Baseline, 1 year	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
Change Polygraphy criteria description	Baseline, 1 year	Apnea-hypopnea index, oxygen saturation , before and after orthognathic surgery

Trial Locations

Locations (1)

Laboratoire de biomécanique Georges CHarpak; 🇫🇷 Paris, France