AnatomyNCT03308318
Does the Deep Layer of the Deep Temporalis Fascia Really Exist?
An observational study of Anatomy and Temporal Region Trauma, run by West China College of Stomatology.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 68 years
- Conditions the study is for
- Anatomy, Temporal Region Trauma
- What is being tested?
- The supratemporalis approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- 17 Jun 2013to 13 Jun 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 68 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients diagnosed with zygomaticofacial fractures or craniofacial fractures and received surgical treatment from the Dr. Lei Liu
Who may be able to join
- Clinical and imaging diagnosis of zygomaticofacial or craniofacial fractures A need to operate using the supratemporalis approach No previously surgical treatment
Who cannot join
- unobvious displaced fracture disagree with the surgical treatment previous unsuccessful surgery at the temporal region
About this study
Official title: A New Discovery on the Temporal Fascial Layers: Does the Deep Layer of the Deep Temporalis Fascia Really Exist?
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.
Read the 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.
- Conditions
- Anatomy, Temporal Region Trauma
- Being tested
- The supratemporalis approach
- Keywords
- Deep temporal fascia, Deep layer of the deep temporal fascia, Superficial layer of the deep temporal fascia, Temporal fascial layers, Temporal anatomy
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The supratemporalis approachProcedure or surgery
The incision differs according to specific fracture sites. It can be a hockey stick-shaped incision, hemicoronal incision, and full coronal incision. The first layer of dissection was just under the superficial temporalis fascia.Then, approximately at the level of 3-5cm above the zygomatic arch, our modified incision was carried through the deep temporalis fascia.Next, the superficial fat pad was encountered and retracted anteriorly, which was in close contact of the temporal muscle. Finally, a flap that included skin, subcutaneous tissue, the superficial temporal fascia, the areolar fat tissue, the deep temporalis fascia and the superficial temporal fat was reflected as a whole anteriorly, fully exposing the temporal muscle and zygomatic arch.
| Study group | Role | What they receive |
|---|---|---|
| the supratemporalis approach | patients operated upon with zygomaticofacial or craniofacial fractures using the supratemporalis approach Receives: Procedure: The supratemporalis approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
deep layer of the deep temporal fascia
the investigators did not find the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start17 Jun 2013
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for AnatomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- West China College of Stomatology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Li, West China College of Stomatology
- Investigators
- Lei Liu, DMD, Study director, Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308318
- Sponsor's protocol ID
- hui_owe
- Status last verified
- Oct 2017
- First submitted
- 5 Oct 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krayenbuhl N, Isolan GR, Hafez A, Yasargil MG. The relationship of the fronto-temporal branches of the facial nerve to the fascias of the temporal region: a literature review applied to practical anatomical dissection. Neurosurg Rev. 2007 Jan;30(1):8-15; discussion 15. doi: 10.1007/s10143-006-0053-5. Epub 2006 Nov 10.
PubMed 17096156O'Brien JX, Ashton MW. Relationship of the temporofrontal rami of the facial nerve to the fascial layers of the temporal region. Ann Plast Surg. 2012 Jun;68(6):547-8. doi: 10.1097/SAP.0b013e318221b563.
PubMed 22643100Ammirati M, Spallone A, Ma J, Cheatham M, Becker D. An anatomicosurgical study of the temporal branch of the facial nerve. Neurosurgery. 1993 Dec;33(6):1038-43; discussion 1044. doi: 10.1227/00006123-199312000-00012.
PubMed 8133989Agarwal CA, Mendenhall SD 3rd, Foreman KB, Owsley JQ. The course of the frontal branch of the facial nerve in relation to fascial planes: an anatomic study. Plast Reconstr Surg. 2010 Feb;125(2):532-537. doi: 10.1097/PRS.0b013e3181c82e9d.
PubMed 20124839Tellioglu AT, Tekdemir I, Erdemli EA, Tuccar E, Ulusoy G. Temporoparietal fascia: an anatomic and histologic reinvestigation with new potential clinical applications. Plast Reconstr Surg. 2000 Jan;105(1):40-5. doi: 10.1097/00006534-200001000-00007.
PubMed 10626968Coscarella E, Vishteh AG, Spetzler RF, Seoane E, Zabramski JM. Subfascial and submuscular methods of temporal muscle dissection and their relationship to the frontal branch of the facial nerve. Technical note. J Neurosurg. 2000 May;92(5):877-80. doi: 10.3171/jns.2000.92.5.0877.
PubMed 10794306Wormald PJ, Alun-Jones T. Anatomy of the temporalis fascia. J Laryngol Otol. 1991 Jul;105(7):522-4. doi: 10.1017/s0022215100116500.
PubMed 1875131Stuzin JM, Wagstrom L, Kawamoto HK, Wolfe SA. Anatomy of the frontal branch of the facial nerve: the significance of the temporal fat pad. Plast Reconstr Surg. 1989 Feb;83(2):265-71. doi: 10.1097/00006534-198902000-00011.
PubMed 2911626Abul-Hassan HS, von Drasek Ascher G, Acland RD. Surgical anatomy and blood supply of the fascial layers of the temporal region. Plast Reconstr Surg. 1986 Jan;77(1):17-28.
PubMed 3941846Tolhurst DE, Carstens MH, Greco RJ, Hurwitz DJ. The surgical anatomy of the scalp. Plast Reconstr Surg. 1991 Apr;87(4):603-12; discussion 613-4.
PubMed 2008459Ramirez OM. Endoscopic techniques in facial rejuvenation: an overview. Part I. Aesthetic Plast Surg. 1994 Spring;18(2):141-7. doi: 10.1007/BF00454473.
PubMed 8017216Stuzin JM, Baker TJ, Gordon HL. The relationship of the superficial and deep facial fascias: relevance to rhytidectomy and aging. Plast Reconstr Surg. 1992 Mar;89(3):441-9; discussion 450-1.
PubMed 1741467Accioli de Vasconcellos JJ, Britto JA, Henin D, Vacher C. The fascial planes of the temple and face: an en-bloc anatomical study and a plea for consistency. Br J Plast Surg. 2003 Oct;56(7):623-9. doi: 10.1016/s0007-1226(03)00310-2.
PubMed 12969659Campiglio GL, Candiani P. Anatomical study on the temporal fascial layers and their relationships with the facial nerve. Aesthetic Plast Surg. 1997 Mar-Apr;21(2):69-74. doi: 10.1007/s002669900086.
PubMed 9143418Rowe NL. Surgery of the temporomandibular joint. Proc R Soc Med. 1972 Apr;65(4):383-8. doi: 10.1177/003591577206500438. No abstract available.
PubMed 5024527
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Discovery on the Temporal Fascial Layers: Does the Deep Layer of the Deep Temporalis Fascia Really Exist?
- ClinicalTrials.gov ID
- NCT03308318
- Acronym / sponsor ID
- hui_owe
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- West China College of StomatologyUniversity, hospital or other
- Study start
- 17 Jun 2013 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the supratemporalis approach | – | Procedure: The supratemporalis approachpatients operated upon with zygomaticofacial or craniofacial fractures using the supratemporalis approach |
Who may qualify
- Ages
- 10 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients diagnosed with zygomaticofacial fractures or craniofacial fractures and received surgical treatment from the Dr. Lei Liu
Key inclusion criteria (1 listed)
- Clinical and imaging diagnosis of zygomaticofacial or craniofacial fractures A need to operate using the supratemporalis approach No previously surgical treatment
Key exclusion criteria (1 listed)
- unobvious displaced fracture disagree with the surgical treatment previous unsuccessful surgery at the temporal region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The supratemporalis approachThe incision differs according to specific fracture sites. It can be a hockey stick-shaped incision, hemicoronal incision, and full coronal incision. The first layer of dissection was just under the superficial temporalis fascia.Then, approximately at the level of 3-5cm above the zygomatic arch, our modified incision was carried through the deep temporalis fascia.Next, the superficial fat pad was encountered and retracted anteriorly, which was in close contact of the temporal muscle. Finally, a flap that included skin, subcutaneous tissue, the superficial temporal fascia, the areolar fat tissue, the deep temporalis fascia and the superficial temporal fat was reflected as a whole anteriorly, fully exposing the temporal muscle and zygomatic arch. | Procedure or surgery | the supratemporalis approach |
Primary outcome
deep layer of the deep temporal fascia
Time frame: during surgery
the investigators did not find the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Background: PubMed 17096156Krayenbuhl N, Isolan GR, Hafez A, Yasargil MG. The relationship of the fronto-temporal branches of the facial nerve to the fascias of the temporal region: a literature review applied to practical anatomical dissection. Neurosurg Rev. 2007 Jan;30(1):8-15; discussion 15. doi: 10.1007/s10143-006-0053-5. Epub 2006 Nov 10.
- Background: PubMed 22643100O'Brien JX, Ashton MW. Relationship of the temporofrontal rami of the facial nerve to the fascial layers of the temporal region. Ann Plast Surg. 2012 Jun;68(6):547-8. doi: 10.1097/SAP.0b013e318221b563.
- Background: PubMed 8133989Ammirati M, Spallone A, Ma J, Cheatham M, Becker D. An anatomicosurgical study of the temporal branch of the facial nerve. Neurosurgery. 1993 Dec;33(6):1038-43; discussion 1044. doi: 10.1227/00006123-199312000-00012.
- Background: PubMed 20124839Agarwal CA, Mendenhall SD 3rd, Foreman KB, Owsley JQ. The course of the frontal branch of the facial nerve in relation to fascial planes: an anatomic study. Plast Reconstr Surg. 2010 Feb;125(2):532-537. doi: 10.1097/PRS.0b013e3181c82e9d.
- Background: PubMed 10626968Tellioglu AT, Tekdemir I, Erdemli EA, Tuccar E, Ulusoy G. Temporoparietal fascia: an anatomic and histologic reinvestigation with new potential clinical applications. Plast Reconstr Surg. 2000 Jan;105(1):40-5. doi: 10.1097/00006534-200001000-00007.
- Background: PubMed 10794306Coscarella E, Vishteh AG, Spetzler RF, Seoane E, Zabramski JM. Subfascial and submuscular methods of temporal muscle dissection and their relationship to the frontal branch of the facial nerve. Technical note. J Neurosurg. 2000 May;92(5):877-80. doi: 10.3171/jns.2000.92.5.0877.
- Background: PubMed 1875131Wormald PJ, Alun-Jones T. Anatomy of the temporalis fascia. J Laryngol Otol. 1991 Jul;105(7):522-4. doi: 10.1017/s0022215100116500.
- Background: PubMed 2911626Stuzin JM, Wagstrom L, Kawamoto HK, Wolfe SA. Anatomy of the frontal branch of the facial nerve: the significance of the temporal fat pad. Plast Reconstr Surg. 1989 Feb;83(2):265-71. doi: 10.1097/00006534-198902000-00011.
- Background: PubMed 3941846Abul-Hassan HS, von Drasek Ascher G, Acland RD. Surgical anatomy and blood supply of the fascial layers of the temporal region. Plast Reconstr Surg. 1986 Jan;77(1):17-28.
- Background: PubMed 2008459Tolhurst DE, Carstens MH, Greco RJ, Hurwitz DJ. The surgical anatomy of the scalp. Plast Reconstr Surg. 1991 Apr;87(4):603-12; discussion 613-4.
- Background: PubMed 8017216Ramirez OM. Endoscopic techniques in facial rejuvenation: an overview. Part I. Aesthetic Plast Surg. 1994 Spring;18(2):141-7. doi: 10.1007/BF00454473.
- Background: PubMed 1741467Stuzin JM, Baker TJ, Gordon HL. The relationship of the superficial and deep facial fascias: relevance to rhytidectomy and aging. Plast Reconstr Surg. 1992 Mar;89(3):441-9; discussion 450-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Liu, DMD study director
Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomy and Temporal Region Trauma, run by West China College of Stomatology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
deep layer of the deep temporal fascia (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308318, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.