Skip to main content
OpenTrials
Completed

NCT Number: NCT07520682

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de chirurgie en maxillo-faciale Hôpital de la Croix Rousse -Lyon

Lyon, France, 69004

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

type of post-operative rehabilitation : with physiotherapy or speech therapy

Other

mean duration of rehabilitation

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: COBA 50

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.