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NCT Number: NCT02466269

Treatment of Diacapitular Condylar Fractures

A new surgical approach, denoted as the supratemporalis approach, was designed to treat diacapitular condylar fractures of the mandibular condyle.This approach prevented facial nerve injury and did not increase the frequency of other complications. Therefore, the investigators suggest this surgical procedure as a routine and safe approach to diacapitular condylar fractures, which can also be applied to temporomandibular joint（TMJ）and to the zygomatic arch.

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Key information

Conditions

Mandibular Fractures Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Facial Injuries Facial Nerve Diseases Facial Nerve Injuries Fractures, Bone Jaw Fractures Maxillofacial Injuries Mouth Diseases Nervous System Diseases Skull Fractures Stomatognathic Diseases Trauma, Nervous System Wounds and Injuries

Age range

4 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

Eighty-four patients (112 sides) with diacapitular condylar fractures were treated surgically. Forty-four patients (64 sides) were treated with the supratemporalis approach, and forty patients (48 sides) were treated with traditional preauricular approach. Data on the surgical procedures and complications were recorded. The follow-up periods were 12 -24months. The evaluated parameters include facial nerve injury，the maximum mouth opening, mandibular movements, occlusion, scar formation，hemorrhage and infection.Seven patients sustained facial nerve paresis in the group treated with the traditional preauricular approach. No case of facial nerve injury was observed in the supratemporalis approach group. No other significant differences were detected between the two groups in the functional and esthetic aspects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical and radiographical diagnosis of DFs;

Exclusion criteria

  • condylar fractures with undisplaced fractures;
  • Fractures without the reduction of the condylar height;
  • A obvious scar at the temporal region, affecting the placement of the original incision.

Treatment and study plan

The supratemporalis approach

Procedure

The supratemporalis approach was applied in treatment of diacapitular condylar fractures

Primary outcomes

  1. Change from facial nerve function at 24 hours postoperatively

    Time frame: 24 hours

    The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.

  2. Change from facial nerve function at 1 week postoperatively

    Time frame: 1 week

    The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.

  3. Change from facial nerve function at 3 months postoperatively

    Time frame: 3 months

    The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.

  4. Change from facial nerve function at 6 months postoperatively

    Time frame: 6 months

    The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.

  5. Change from facial nerve function at 12 months postoperatively

    Time frame: 12 months

    The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.

Sponsors and collaborators

Lead sponsor

Hui Li

Other

Collaborators

  • West China College of Stomatology

Registry information

Official study title

A Modified Preauricular Approach to Treat Diacapitular Condylar Fractures: The Supratemporalis Approach

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2015
Registry last updated
Oct 25, 2017

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.

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