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Clinical Trials in France / NCT04776473
Recruiting Not applicable

Treatment of Intra-articular Fractures of the Mandibular Condyle

NCT04776473 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2023-05-03
Last updated
2023-05-16

Condition(s) studied

Intra-articular Fracture of the Mandibular Condyle

Investigational drug(s) / intervention(s)

Open treatmentClosed treatment

Open treatment: Open (i.e. surgical) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.

Closed treatment: Closed (i.e. conservative) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.

Study summary

Intra-articular fractures of the mandibular condyle ((IAFC) are usually treated by means of physical therapy with or without transient maxillo-mandibular fixation (conservative or closed treatment). However, this can lead to incomplete manducatory function recovery due to limited mandibular mobility. During the last 15 years, a growing interest has emerged for open (surgical) treatment of these fractures. Although there is more and more evidence suggesting that the open treatment may be the treatment of choice for selected cases of subcondylar fractures, the best option remains controversial for high condylar fractures.

The primary objective of the trial is to compare mandibular mobility at 3 months post-treatment between open (surgical) and closed (conservative) treatment of intra-articular fracture (high fracture) of the mandibular condyle.

This study is an open multicenter randomized controlled trial with 2 parallel arms. Eligible patients will be randomized 1 :1 between open and closed-treatment group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
84 Years
Healthy volunteers
No
Inclusion Criteria: 1. Adult (≥18 y-o) \< 85 years 2. Displaced non-comminuted intra-articular fracture of the mandibular condyle (IAFC) as defined by a fracture line above a horizontal line tangent to the mandibular notch 3. Objectifiable induced malocclusion and/or ramus shortening ≥2 mm on CT-scan (a ramus shortening ≥2 mm on CT-scan is necessary in case of other associated mandibular or occluso-facial fractures) 4. Unilateral or bilateral fracture 5. Isolated or associated with other facial / extra-facial skeleton / dental / soft tissue lesions 6. Treatment within 14 days post trauma 7. Affiliation to a social security regime (excepted AME) 8. Written informed consent Exclusion Criteria: 1. Contraindication to surgical treatment (for any medical or anatomical reason, like comminuted fracture for instance) 2. Major teeth loss or edentulous patient (occlusion impossible to assess) 3. History of mandibular fracture 4. History of temporo-mandibular joint (TMJ) disorder 5. Dentofacial dysmorphosis causing significant malocclusion 6. Predictable inability to comply with the follow-up 7. Unconsciousness / severe polytrauma 8. Participation in another interventional study

Primary outcome measure(s)

  • Maximal mouth opening (in mm) at 3 months — 3 months (+/-10 days)
    It will be obtained by measuring the interincisal distance at maximum mouth opening with a caliper or a ruler. The patient will be first asked to open the mouth as widely as possible for 3 seconds and to rest for 5 seconds. This sequence will be repeated 2 times and at the third repetition the patient will keep his/her mouth opened while the physician will measure inter-incisal distance

Trial sites (7)

FacilityCityRegionStatus
CHU Angers Angers France Not Yet Recruiting
Hôpital Annecy Genevois Annecy France Not Yet Recruiting
APHM - Hôpital de la Conception Marseille France Not Yet Recruiting
CHU de Nantes Nantes France Not Yet Recruiting
Hôpital Pitié-Salpêtrière Paris France Recruiting
Hôpitaux Universitaires de Strasbourg Strasbourg France Not Yet Recruiting
CHU Purpan - Hôpital Pierre-Paul Riquet Toulouse France Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04776473 on ClinicalTrials.gov ↗ ← All trials in France