Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-03 @ 3:01 PM
Study NCT ID:
NCT03308318
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2017-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does the Deep Layer of the Deep Temporalis Fascia Really Exist?
Sponsor:
Organization:
Raw JSON
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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.'}, {'pmid': '22643100', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '8133989', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20124839', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10626968', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10794306', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1875131', 'type': 'BACKGROUND', 'citation': 'Wormald PJ, Alun-Jones T. Anatomy of the temporalis fascia. J Laryngol Otol. 1991 Jul;105(7):522-4. doi: 10.1017/s0022215100116500.'}, {'pmid': '2911626', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '3941846', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2008459', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8017216', 'type': 'BACKGROUND', 'citation': 'Ramirez OM. Endoscopic techniques in facial rejuvenation: an overview. Part I. Aesthetic Plast Surg. 1994 Spring;18(2):141-7. doi: 10.1007/BF00454473.'}, {'pmid': '1741467', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12969659', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9143418', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '5024527', 'type': 'BACKGROUND', 'citation': 'Rowe NL. Surgery of the temporomandibular joint. Proc R Soc Med. 1972 Apr;65(4):383-8. doi: 10.1177/003591577206500438. No abstract available.'}, {'pmid': '298842', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15346360', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22446445', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9178446', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9105349', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7598027', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22705217', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26844401', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20083736', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16192853', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8141539', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1852815', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15035289', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20679939', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients diagnosed with zygomaticofacial fractures or craniofacial fractures and received surgical treatment from the Dr. Lei Liu', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical and imaging diagnosis of zygomaticofacial or craniofacial fractures A need to operate using the supratemporalis approach No previously surgical treatment\n\nExclusion Criteria:\n\nunobvious displaced fracture disagree with the surgical treatment previous unsuccessful surgery at the temporal region'}, 'identificationModule': {'nctId': 'NCT03308318', 'briefTitle': 'Does the Deep Layer of the Deep Temporalis Fascia Really Exist?', 'organization': {'class': 'OTHER', 'fullName': 'West China College of Stomatology'}, 'officialTitle': 'A New Discovery on the Temporal Fascial Layers: Does the Deep Layer of the Deep Temporalis Fascia Really Exist?', 'orgStudyIdInfo': {'id': 'hui_owe'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the supratemporalis approach', 'description': 'patients operated upon with zygomaticofacial or craniofacial fractures using the supratemporalis approach', 'interventionNames': ['Procedure: The supratemporalis approach']}], 'interventions': [{'name': 'The supratemporalis approach', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['the supratemporalis approach']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lei Liu, DMD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China College of Stomatology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hui Li', 'investigatorAffiliation': 'West China College of Stomatology'}}}}