Dentofacial DeformitiesNCT03532828
Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients
A study testing polysomnography in people with Dentofacial Deformities and Sleep Disorder, run by Laboratoire de Biomécanique Georges Charpak at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dentofacial Deformities, Sleep Disorder, Posture
- What is being tested?
- polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient in orthodontic preparation for a surgical treatment,
- age > 16 years
Who cannot join
- postural disorder (scoliosis, history of spine surgery),
- pregnancy or breastfeeding,
- patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nocturnal Respiratory Disorders Identification and Their Influence on the Body Posture and Breathing Synchronisation in Patients With Dentofacial Dysgnathia
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
- Conditions
- Dentofacial Deformities, Sleep Disorder, Posture
- Being tested
- polysomnography
- Medical subject headings
- Dentofacial Deformities, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyOther
Also called Postural evaluation
Patients will have a polygraphy, a postural evaluation including Vicon system, EOS imaging, ang a force platform
| Study group | Role | What they receive |
|---|---|---|
| Polysomnography alone | Experimental | A polygraphy will be performed in 70 patient to search for obstructive sleep apnea Receives: Other: polysomnography |
| Polysomnography and postural assesment | Experimental | A polygraphy and a postural assesment will be performed in 30 patients Receives: Other: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 2D displacement range of the pressure center
Pressure center is recorded with force plates 1month before and 1 year after orthognathic surgery
Measured: Baseline, 1 year
Secondary outcomes (5)
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
Measured: Baseline, 1 year
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
Measured: Baseline, 1 year
Change in Cephalometric analysis
Lateral cephalograms are recorded before and after surgery
Measured: Baseline, 1 year
Change Polygraphy criteria description
Apnea-hypopnea index, oxygen saturation , before and after orthognathic surgery
Measured: Baseline, 1 year
Change in Dentofacial deformities description
Clinical evaluation before and after surgery
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start9 Apr 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire de Biomécanique Georges Charpak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532828
- Sponsor's protocol ID
- Dysmorphie / SAS
- Status last verified
- Aug 2025
- First submitted
- 10 Apr 2018
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Respiratory Disorders Identification and Their Influence on the Body Posture and Breathing Synchronisation in Patients With Dentofacial Dysgnathia
- ClinicalTrials.gov ID
- NCT03532828
- Acronym / sponsor ID
- Dysmorphie / SAS
- Conditions
- Dentofacial Deformities, Sleep Disorder, Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Laboratoire de Biomécanique Georges CharpakUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polysomnography alone | Experimental | Other: polysomnographyA polygraphy will be performed in 70 patient to search for obstructive sleep apnea |
| Polysomnography and postural assesment | Experimental | Other: polysomnographyA polygraphy and a postural assesment will be performed in 30 patients |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient in orthodontic preparation for a surgical treatment,
- age > 16 years
Key exclusion criteria (3 listed)
- postural disorder (scoliosis, history of spine surgery),
- pregnancy or breastfeeding,
- patients under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polysomnographyAlso: Postural evaluationPatients will have a polygraphy, a postural evaluation including Vicon system, EOS imaging, ang a force platform | Other | Polysomnography alone, Polysomnography and postural assesment |
Primary outcome
Change in 2D displacement range of the pressure center
Time frame: Baseline, 1 year
Pressure center is recorded with force plates 1month before and 1 year after orthognathic surgery
5 secondary outcomes
Change in EOS criteria description
Time frame: Baseline, 1 year
Change Stabilometric criteria description
Time frame: Baseline, 1 year
Change in Cephalometric analysis
Time frame: Baseline, 1 year
Change Polygraphy criteria description
Time frame: Baseline, 1 year
Change in Dentofacial deformities description
Time frame: Baseline, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Dentofacial Deformities
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With Eye-tracking
Dentofacial Deformities, Orthognathic Surgery
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polysomnography in people with Dentofacial Deformities and Sleep Disorder, run by Laboratoire de Biomécanique Georges Charpak at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 2D displacement range of the pressure center (time frame: Baseline, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.