- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520682
Orthognathic Surgery in Anterior Open Bite: a Retrospective Study of 50 Patients With Initial Tongue Malposition (COBA 50)
The anterior gap is defined by a lack of contact between the upper and lower dental arches.
It is mainly due to the persistence of infantile swallowing during and after childhood, i.e. interposition of the tongue between the two dental arches.
Patients presenting with an anterior gap in adulthood are likely to develop functional sequelae (masticatory difficulties, dental loosening, periodontal disease, etc.) and aesthetic sequelae (edentulous smile, excess height of the lower third of the face compared to the upper and middle third).
Patients who are diagnosed with this condition very often benefit from orthodontic-surgical treatment, comprising a period of orthodontics followed by orthognathic surgery to close the anterior gap. This is combined with lingual re-education to treat infantile swallowing. This lingual re-education is not always carried out, either because infantile swallowing has not been diagnosed, or because of a lack of cooperation on the part of the patient, or because of difficulties in finding a suitable specialist. When rehabilitation is introduced, it is sometimes only after surgery, and for a short time.
For example, it has been observed that among all patients undergoing orthognathic surgery, those with an anterior gap were particularly at risk of surgical treatment failure, or recurrence in the short to medium term.
The main reason cited was the persistence of infantile swallowing and consequent malpositioning of the tongue between the dental arches, creating permanent pressure on the lingual surface of the teeth and eventually leading to recurrence of the gap.
Identifying patient management factors associated with postoperative recurrence of anterior hollowness in patients with infantile swallowing would enable us to adapt the management of these patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
France
-
Lyon, France, France, 69004
- Service de chirurgie en maxillo-faciale Hôpital de la Croix Rousse -Lyon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Major patients
- Having undergone ortho gnathic surgery in the Maxillofacial Surgery Department of the Croix Rousse Hospital
- Patients with an anterior gap of more than 3 mm
- Abnormal tongue position at diagnosis
Exclusion Criteria:
- Syndromic patients (cleft lip and palate, craniostenosis)
- Patient refusal
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Relapse of anterior open bite
All patients who presented relapse of anterior open bite after 6 months post operative.
|
mean duration of rehabilitation
|
|
No relapse of anterior open bite
All patients who did not present a relapse of anterior open bite after 6 months post operative.
|
mean duration of rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of the association between anterior open bite recurrence, defined as the absence of contact between the upper and lower incisors at 6 months postoperatively, and the rehabilitation factors.
Time Frame: 6 months
|
Duration of rehabilitation in months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-5191
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients With Anterior Open Bite Malocclusion and Who Benefited of an Orthognathic Surgery
-
Bezmialem Vakif UniversityCompletedMalocclusion | Orthognathic Surgery | Open Bite | Le Fort; ITurkey
Clinical Trials on type of post-operative rehabilitation : with physiotherapy or speech therapy
-
Khoo Teck Puat HospitalMinistry of Health, SingaporeActive, not recruitingHip Fracture Surgeries | Post-operative Hip Fractures RecoverySingapore
-
IRCCS San RaffaeleEnrolling by invitationPrimary Progressive Aphasia(PPA)Italy
-
Parc de Salut MarRecruitingDisability Physical | STROKE | Brain Disease | Hemiplegia and/or Hemiparesis Following Stroke | Rehabilitation Outcome | Cardiovascular Disease AcuteSpain
-
Centre Hospitalier Universitaire de NīmesNot yet recruitingBack Pain Lower Back ChronicFrance
-
Spanish Foundation for Neurometrics DevelopmentFundacion para la Salud Materno InfantilEnrolling by invitationSocial Behavior | Attention | EEG With Periodic Abnormalities | Visual Perceptual Weakness | Fluency DisorderUnited States
-
Washington University School of MedicineTerminated
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUnknownBreast Cancer Nos PremenopausalChina
-
Technical University of BernNot yet recruitingSpasticitySwitzerland, United Kingdom
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
Centre Cardiologique du NordNot yet recruitingPost-operative Delirium | Anaesthetic DepthFrance