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CompletedNCT03308318Updated Oct 13, 2017

Does the Deep Layer of the Deep Temporalis Fascia Really Exist?

An observational study in Anatomy and Temporal Region Trauma, sponsored by West China College of Stomatology. Completed. Open to participants aged 10 Years to 68 Years. Per ClinicalTrials.gov, last updated 2017-10-13.

Sponsored by West China College of Stomatology · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
167
Ages
10 Years to 68 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • Anatomy
  • Temporal Region Trauma

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Keywords

  • Deep temporal fascia
  • Deep layer of the deep temporal fascia
  • Superficial layer of the deep temporal fascia
  • Temporal fascial layers
  • Temporal anatomy
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In context

Craniocerebral Trauma

253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.

This study's enrollment of 167 is close to the median of 180 across 111 observational studies indexed under Craniocerebral Trauma.

Browse Craniocerebral Trauma studies →

Lead sponsor

West China College of Stomatology is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 68 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

all patients diagnosed with zygomaticofacial fractures or craniofacial fractures and received surgical treatment from the Dr. Lei Liu

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
167 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • the supratemporalis approach

    patients operated upon with zygomaticofacial or craniofacial fractures using the supratemporalis approach

    Procedure: The supratemporalis approach

Interventions

  • ProcedureThe supratemporalis approach

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: during surgery

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Study locations

No study locations are listed for this record.

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References and documents

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 17096156 ↗
  • O'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 22643100 ↗
  • Ammirati 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 8133989 ↗
  • Agarwal 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 20124839 ↗
  • Tellioglu 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 10626968 ↗
  • Coscarella 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 10794306 ↗
  • Wormald PJ, Alun-Jones T. Anatomy of the temporalis fascia. J Laryngol Otol. 1991 Jul;105(7):522-4. doi: 10.1017/s0022215100116500. PubMed 1875131 ↗
  • Stuzin 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 2911626 ↗
  • Abul-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 3941846 ↗
  • Tolhurst 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 2008459 ↗
  • Ramirez OM. Endoscopic techniques in facial rejuvenation: an overview. Part I. Aesthetic Plast Surg. 1994 Spring;18(2):141-7. doi: 10.1007/BF00454473. PubMed 8017216 ↗
  • Stuzin 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 1741467 ↗
  • Accioli 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 12969659 ↗
  • Campiglio 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 9143418 ↗
  • Rowe NL. Surgery of the temporomandibular joint. Proc R Soc Med. 1972 Apr;65(4):383-8. No abstract available. PubMed 5024527 ↗
  • Al-Kayat A, Bramley P. A modified pre-auricular approach to the temporomandibular joint and malar arch. Br J Oral Surg. 1979 Nov;17(2):91-103. doi: 10.1016/s0007-117x(79)80036-0. PubMed 298842 ↗
  • Politi M, Toro C, Cian R, Costa F, Robiony M. The deep subfascial approach to the temporomandibular joint. J Oral Maxillofac Surg. 2004 Sep;62(9):1097-102. doi: 10.1016/j.joms.2003.10.013. PubMed 15346360 ↗
  • Candirli C, Celik S. Efficacy of deep subfascial approach to the temporomandibular joint. J Craniofac Surg. 2012 Mar;23(2):e126-9. doi: 10.1097/SCS.0b013e31824cdb5c. PubMed 22446445 ↗
  • Nellestam P, Eriksson L. Preauricular approach to the temporomandibular joint: a postoperative follow-up on nerve function, hemorrhage and esthetics. Swed Dent J. 1997;21(1-2):19-24. PubMed 9178446 ↗
  • Gosain AK, Sewall SR, Yousif NJ. The temporal branch of the facial nerve: how reliably can we predict its path? Plast Reconstr Surg. 1997 Apr;99(5):1224-33; discussion 1234-6. doi: 10.1097/00006534-199704001-00003. PubMed 9105349 ↗
  • Hochberg J, Kaufman H, Ardenghy M. Saving the frontal branch during a low fronto-orbital approach. Aesthetic Plast Surg. 1995 Mar-Apr;19(2):161-3. doi: 10.1007/BF00450252. PubMed 7598027 ↗
  • Kenkere D, Srinath KS, Reddy M. Deep subfascial approach to the temporal area. J Oral Maxillofac Surg. 2013 Feb;71(2):382-8. doi: 10.1016/j.joms.2012.04.019. Epub 2012 Jun 16. PubMed 22705217 ↗
  • Li H, Zhang G, Cui J, Liu W, Dilxat D, Liu L. A Modified Preauricular Approach for Treating Intracapsular Condylar Fractures to Prevent Facial Nerve Injury: The Supratemporalis Approach. J Oral Maxillofac Surg. 2016 May;74(5):1013-22. doi: 10.1016/j.joms.2015.12.013. Epub 2016 Jan 7. PubMed 26844401 ↗
  • Babakurban ST, Cakmak O, Kendir S, Elhan A, Quatela VC. Temporal branch of the facial nerve and its relationship to fascial layers. Arch Facial Plast Surg. 2010 Jan-Feb;12(1):16-23. doi: 10.1001/archfacial.2009.96. PubMed 20083736 ↗
  • Kim S, Matic DB. The anatomy of temporal hollowing: the superficial temporal fat pad. J Craniofac Surg. 2005 Sep;16(5):760-3. doi: 10.1097/01.scs.0000180010.83480.10. PubMed 16192853 ↗
  • Tremolada C, Candiani P, Signorini M, Vigano M, Donati L. The surgical anatomy of the subcutaneous fascial system of the scalp. Ann Plast Surg. 1994 Jan;32(1):8-14. doi: 10.1097/00000637-199401000-00002. PubMed 8141539 ↗
  • Ramirez OM, Maillard GF, Musolas A. The extended subperiosteal face lift: a definitive soft-tissue remodeling for facial rejuvenation. Plast Reconstr Surg. 1991 Aug;88(2):227-36; discussion 237-8. PubMed 1852815 ↗
  • Kadri PA, Al-Mefty O. The anatomical basis for surgical preservation of temporal muscle. J Neurosurg. 2004 Mar;100(3):517-22. doi: 10.3171/jns.2004.100.3.0517. PubMed 15035289 ↗
  • Davidge KM, van Furth WR, Agur A, Cusimano M. Naming the soft tissue layers of the temporoparietal region: unifying anatomic terminology across surgical disciplines. Neurosurgery. 2010 Sep;67(3 Suppl Operative):ons120-9; discussion ons129-30. doi: 10.1227/01.NEU.0000383132.34056.61. PubMed 20679939 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2013 to primary completion in Jun 2017, 47 months.

Of 43 non-industry observational studies under Craniocerebral Trauma, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 49. This study's 47 months is above that.

Counting every sponsor, half of 43 studies reached it within 32 months; a quarter within 15 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2017
First posted
Oct 12, 2017
StartActual
Jun 17, 2013
Primary completionActual
Jun 13, 2017
CompletionActual
Jun 13, 2017
Last update
Oct 13, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03308318
Lead sponsor
West China College of Stomatology
Responsible party
Hui Li (Principal Investigator, West China College of Stomatology) — Principal investigator
First posted
Oct 12, 2017
Start date
Jun 17, 2013
Primary completion
Jun 13, 2017
Completion
Jun 13, 2017
Last update
Oct 13, 2017

Study contacts

Lei Liu, DMD
study director · Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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