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Treatment of Intra-articular Fractures of the Mandibular Condyle

NCT04776473 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-05-16

No results posted yet for this 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.

Conditions

  • Intra-articular Fracture of the Mandibular Condyle

Interventions

PROCEDURE

Open treatment

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

OTHER

Closed treatment

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Thomas SCHOUMAN, MD · AP-HP - Hôpital Pitié-Salpêtrière

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2026-08-31
Completion
2027-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04776473 on ClinicalTrials.gov