Clinical trial NCT03308318: Does the Deep Layer of the Deep Temporalis Fascia Really Exist?
Official title: A New Discovery on the Temporal Fascial Layers: Does the Deep Layer of the Deep Temporalis Fascia Really Exist?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anatomy
Temporal Region Trauma
Keywords: Deep temporal fascia
Deep layer of the deep temporal fascia
Superficial layer of the deep temporal fascia
Temporal fascial layers
Temporal anatomy
Lead sponsor: West China College of Stomatology
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 167
Sex: ALL
Minimum age (years): 10
Maximum age (years): 68
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients diagnosed with zygomaticofacial fractures or craniofacial fractures and received surgical treatment from the Dr. Lei Liu

Brief summary: It has been widely accepted that a split of the deep temporal fascia occurs approximately 2 to 3 cm above the zygomatic arch, named the superficial and deep layers. The deep layer of the deep temporal fascia lies between superficial temporal fat pad and the temporal muscle. However, during the investigators' previous surgeries, the investigators did not find the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle. This study was conducted to clarify the presence or absence of the deep layer of the deep temporal fascia. And the investigators' clinical study has confirmed the absence of the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle.

Detailed description: The anatomic layers of soft tissues of the temporal region, with regard to the deep temporalis fascia, was investigated in 169 cases operated upon with zygomaticofacial or craniofacial fractures using the supratemporalis approach from June 2013 to June 2017. Among 167 surgeries, this so-called "deep layer of the deep temporalis fascia" was not observed. In fact, the superficial temporal fat pad is closely attached to temporal muscle above the zygomatic arch.

Eligibility criteria: Inclusion Criteria:

Clinical and imaging diagnosis of zygomaticofacial or craniofacial fractures A need to operate using the supratemporalis approach No previously surgical treatment

Exclusion Criteria:

unobvious displaced fracture disagree with the surgical treatment previous unsuccessful surgery at the temporal region

Primary outcomes:
measure: deep layer of the deep temporal fascia
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
name: Lei Liu, DMD
role: STUDY_DIRECTOR
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