Orthognathic Surgery in Anterior Open Bite: a Retrospective Study of 50 Patients With Initial Tongue Malposition (COBA 50)

April 2, 2026 updated by: Hospices Civils de Lyon

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

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • France
      • Lyon, France, France, 69004
        • Service de chirurgie en maxillo-faciale Hôpital de la Croix Rousse -Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients undergoing orthognathic surgery with a gap prior to surgery (50 patients)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

  • assess the tongue position at rest, and during speech
  • assess the surgical movements associated with relapse : advancement, rotation, expansion, genioplasty
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

  • assess the tongue position at rest, and during speech
  • assess the surgical movements associated with relapse : advancement, rotation, expansion, genioplasty

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

August 1, 2025

Study Registration Dates

First Submitted

July 28, 2025

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

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.

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