NCT03532828

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

4.7 years

First QC Date

April 10, 2018

Last Update Submit

August 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in EOS criteria description

    Baseline, 1 year

  • Change Stabilometric criteria description

    Baseline, 1 year

  • Change in Cephalometric analysis

    Baseline, 1 year

  • Change Polygraphy criteria description

    Baseline, 1 year

  • Change in Dentofacial deformities description

    Baseline, 1 year

Study Arms (2)

Polysomnography alone

EXPERIMENTAL

A polygraphy will be performed in 70 patient to search for obstructive sleep apnea

Other: polysomnography

Polysomnography and postural assesment

EXPERIMENTAL

A polygraphy and a postural assesment will be performed in 30 patients

Other: polysomnography

Interventions

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

Also known as: Postural evaluation
Polysomnography alonePolysomnography and postural assesment

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patient in orthodontic preparation for a surgical treatment,
  • age \> 16 years

You may not qualify if:

  • postural disorder (scoliosis, history of spine surgery),
  • pregnancy or breastfeeding,
  • patients under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire de biomécanique Georges CHarpak

Paris, 75013, France

Location

MeSH Terms

Conditions

Dentofacial DeformitiesSleep Wake Disorders

Condition Hierarchy (Ancestors)

Maxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2018

First Posted

May 22, 2018

Study Start

April 9, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations