Comparing surgical and conservative treatments for jaw fractures
Official title: Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial
Run by Assistance Publique - Hôpitaux de Paris · NCT04776473 · Data updated 2026-11-12
This study is testing whether surgery or non-surgical treatment works better for adults with certain types of jaw fractures to help them move their jaw more easily after three months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 84 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 7 sites (Angers and 6 other locations) |
| Status | Recruiting |
| Started | May 3, 2023 |
| Main results expected | August 2026 |
| Study ends | May 2027 |
| Registry record updated | May 16, 2023 |
| Trial ID | NCT04776473 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 85 with specific types of displaced non-comminuted intra-articular fractures of the mandibular condyle.
✕Probably not a fit
Patients with contraindications to surgical treatment, major teeth loss, or a history of TMJ disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of open surgical treatment versus conservative treatment for intra-articular fractures of the mandibular condyle. It is a multicenter randomized controlled trial where eligible adult patients with specific types of jaw fractures will be randomly assigned to either treatment group. The primary outcome measure is the level of mandibular mobility assessed three months post-treatment, which will help determine the best approach for these fractures. The study addresses a significant gap in current treatment strategies, as no prior randomized controlled trials have compared these two methods directly.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery of jaw function for patients with intra-articular fractures.
How similar studies have gone: While there is growing evidence supporting surgical treatment for low-level fractures, this study is novel as it directly compares open versus closed treatment for high condylar fractures.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hôpital Pitié-Salpêtrière
Paris, France Recruiting -
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 -
Hôpitaux Universitaires de Strasbourg
Strasbourg, France Not yet recruiting
Show 1 more location
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CHU Purpan - Hôpital Pierre-Paul Riquet
Toulouse, France Not yet recruiting
Study contacts
- Principal investigator: Thomas SCHOUMAN, MD — AP-HP - Hôpital Pitié-Salpêtrière
- Study coordinator: Thomas SCHOUMAN, MD
- Email: thomas.schouman@aphp.fr
- Phone: (0)1 42 16 13 01
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.