Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-29 @ 12:24 PM
Study NCT ID:
NCT02992366
Status:
UNKNOWN
Last Update Posted:
2016-12-14
First Post:
2016-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
: SOCKET SHIELD TECHNIQUE VERSUS EMPTY SOCKET TECHNIQUE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-10', 'studyFirstSubmitDate': '2016-12-10', 'studyFirstSubmitQcDate': '2016-12-10', 'lastUpdatePostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vertical and horizontal bone level', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Pocket probing depth', 'timeFrame': '9 months'}, {'measure': 'Labial Alveolar crestal bone height compared with the lingual side', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['socket shield', 'volumetric tissue alteration', 'immediate implant'], 'conditions': ['Dental Implant Placement', 'Socket Shield Technique Implant Placement']}, 'referencesModule': {'references': [{'pmid': '12956657', 'type': 'BACKGROUND', 'citation': 'Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x.'}, {'pmid': '15882225', 'type': 'BACKGROUND', 'citation': 'Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. J Clin Periodontol. 2005 Jun;32(6):645-52. doi: 10.1111/j.1600-051X.2005.00726.x.'}, {'pmid': '12956475', 'type': 'BACKGROUND', 'citation': 'Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.'}, {'pmid': '15635945', 'type': 'BACKGROUND', 'citation': 'Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.'}, {'pmid': '16907764', 'type': 'BACKGROUND', 'citation': 'Botticelli D, Persson LG, Lindhe J, Berglundh T. Bone tissue formation adjacent to implants placed in fresh extraction sockets: an experimental study in dogs. Clin Oral Implants Res. 2006 Aug;17(4):351-8. doi: 10.1111/j.1600-0501.2006.01270.x.'}, {'pmid': '18983313', 'type': 'BACKGROUND', 'citation': 'Fickl S, Zuhr O, Wachtel H, Bolz W, Huerzeler MB. Hard tissue alterations after socket preservation: an experimental study in the beagle dog. Clin Oral Implants Res. 2008 Nov;19(11):1111-8. doi: 10.1111/j.1600-0501.2008.01575.x.'}, {'pmid': '13793201', 'type': 'BACKGROUND', 'citation': 'AMLER MH, JOHNSON PL, SALMAN I. Histological and histochemical investigation of human alveolar socket healing in undisturbed extraction wounds. J Am Dent Assoc. 1960 Jul;61:32-44. doi: 10.14219/jada.archive.1960.0152. No abstract available.'}, {'pmid': '18713258', 'type': 'BACKGROUND', 'citation': 'Fickl S, Zuhr O, Wachtel H, Stappert CF, Stein JM, Hurzeler MB. Dimensional changes of the alveolar ridge contour after different socket preservation techniques. J Clin Periodontol. 2008 Oct;35(10):906-13. doi: 10.1111/j.1600-051X.2008.01305.x. Epub 2008 Aug 17.'}, {'pmid': '5224784', 'type': 'BACKGROUND', 'citation': 'Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. J Prosthet Dent. 1967 Jan;17(1):21-7. doi: 10.1016/0022-3913(67)90046-7. No abstract available.'}, {'pmid': '22211305', 'type': 'BACKGROUND', 'citation': 'Lang NP, Pun L, Lau KY, Li KY, Wong MC. A systematic review on survival and success rates of implants placed immediately into fresh extraction sockets after at least 1 year. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:39-66. doi: 10.1111/j.1600-0501.2011.02372.x.'}, {'pmid': '15367183', 'type': 'BACKGROUND', 'citation': 'Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. doi: 10.1111/j.1600-051X.2004.00565.x.'}, {'pmid': '22211307', 'type': 'BACKGROUND', 'citation': 'Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.'}, {'pmid': '15635942', 'type': 'BACKGROUND', 'citation': 'Chen ST, Wilson TG Jr, Hammerle CH. Immediate or early placement of implants following tooth extraction: review of biologic basis, clinical procedures, and outcomes. Int J Oral Maxillofac Implants. 2004;19 Suppl:12-25.'}, {'pmid': '19419446', 'type': 'BACKGROUND', 'citation': 'Fickl S, Schneider D, Zuhr O, Hinze M, Ender A, Jung RE, Hurzeler MB. Dimensional changes of the ridge contour after socket preservation and buccal overbuilding: an animal study. J Clin Periodontol. 2009 May;36(5):442-8. doi: 10.1111/j.1600-051X.2009.01381.x.'}, {'pmid': '12562374', 'type': 'BACKGROUND', 'citation': 'Vermylen K, Collaert B, Linden U, Bjorn AL, De Bruyn H. Patient satisfaction and quality of single-tooth restorations. Clin Oral Implants Res. 2003 Feb;14(1):119-24. doi: 10.1034/j.1600-0501.2003.140116.x.'}, {'pmid': '23631704', 'type': 'BACKGROUND', 'citation': 'Baumer D, Zuhr O, Rebele S, Schneider D, Schupbach P, Hurzeler M. The socket-shield technique: first histological, clinical, and volumetrical observations after separation of the buccal tooth segment - a pilot study. Clin Implant Dent Relat Res. 2015 Feb;17(1):71-82. doi: 10.1111/cid.12076. Epub 2013 Apr 30.'}, {'pmid': '24392492', 'type': 'BACKGROUND', 'citation': 'Cherel F, Etienne D. Papilla preservation between two implants: a modified socket-shield technique to maintain the scalloped anatomy? A case report. Quintessence Int. 2014 Jan;45(1):23-30. doi: 10.3290/j.qi.a30765.'}, {'pmid': '23342355', 'type': 'BACKGROUND', 'citation': 'Kan JY, Rungcharassaeng K. Proximal socket shield for interimplant papilla preservation in the esthetic zone. Int J Periodontics Restorative Dent. 2013 Jan-Feb;33(1):e24-31. doi: 10.11607/prd.1346.'}, {'pmid': '23720038', 'type': 'BACKGROUND', 'citation': 'Scheuber S, Bosshardt D, Bragger U, von Arx T. [Implant therapy following trauma of the anterior teeth - a new method for alveolar ridge preservation after post-traumatic ankylosis and external root resorption]. Schweiz Monatsschr Zahnmed. 2013;123(5):417-39. French, German.'}, {'pmid': '15877745', 'type': 'BACKGROUND', 'citation': 'Parlar A, Bosshardt DD, Unsal B, Cetiner D, Haytac C, Lang NP. New formation of periodontal tissues around titanium implants in a novel dentin chamber model. Clin Oral Implants Res. 2005 Jun;16(3):259-67. doi: 10.1111/j.1600-0501.2005.01123.x.'}, {'pmid': '19604282', 'type': 'BACKGROUND', 'citation': 'Davarpanah M, Szmukler-Moncler S. Unconventional implant treatment: I. Implant placement in contact with ankylosed root fragments. A series of five case reports. Clin Oral Implants Res. 2009 Aug;20(8):851-6. doi: 10.1111/j.1600-0501.2008.01653.x.'}, {'pmid': '18724850', 'type': 'BACKGROUND', 'citation': 'Donos N, Mardas N, Chadha V. Clinical outcomes of implants following lateral bone augmentation: systematic assessment of available options (barrier membranes, bone grafts, split osteotomy). J Clin Periodontol. 2008 Sep;35(8 Suppl):173-202. doi: 10.1111/j.1600-051X.2008.01269.x.'}, {'pmid': '18092446', 'type': 'BACKGROUND', 'citation': 'Salama M, Ishikawa T, Salama H, Funato A, Garber D. Advantages of the root submergence technique for pontic site development in esthetic implant therapy. Int J Periodontics Restorative Dent. 2007 Dec;27(6):521-7.'}, {'pmid': '2614633', 'type': 'BACKGROUND', 'citation': 'Bowers GM, Chadroff B, Carnevale R, Mellonig J, Corio R, Emerson J, Stevens M, Romberg E. Histologic evaluation of new attachment apparatus formation in humans. Part III. J Periodontol. 1989 Dec;60(12):683-93. doi: 10.1902/jop.1989.60.12.683.'}, {'pmid': '20712701', 'type': 'BACKGROUND', 'citation': 'Hurzeler MB, Zuhr O, Schupbach P, Rebele SF, Emmanouilidis N, Fickl S. The socket-shield technique: a proof-of-principle report. J Clin Periodontol. 2010 Sep;37(9):855-62. doi: 10.1111/j.1600-051X.2010.01595.x.'}, {'pmid': '24660198', 'type': 'BACKGROUND', 'citation': 'Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical and radiographic outcomes of socket shield technique compared with conventional immediate implant placement.', 'detailedDescription': 'To evaluate the clinical and radiographic outcomes of socket shield technique compared with conventional immediate implant placement.\n\nPICO\n\n* P: patient require immediate dental implant placement for esthetic consideration\n* I: socket shield technique\n* C: conventional immediate implant placement\n* O:\n\nOutcome name Measuring device Measuring unit Primary outcome Vertical and horizontal bone level Cone beam Computer Tomography (CBCT) Millimeter Secondary outcome (a) Pocket probing depth Periodontal probe Millimeter Secondary outcome (b) Labial Alveolar crestal bone height compared with the lingual side Cone beam Computer Tomography (CBCT) Millimeter'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with remaining roots in the esthetic zone with intact periodontal condition indicated for extraction.\n2. Physically able to tolerate conventional surgical and restorative procedures\n3. Signing of an informed consent form\n4. Implant insertion torque \\> 32 N cm with good primary stability\n\nExclusion Criteria:\n\n1. Systemic diseases contraindicating implant placement eg uncontrolled diabetes\n2. Severe bruxism\n3. Active infection in the teeth to be treated\n4. Vertical root fractures with displacement in the teeth of the surgical area'}, 'identificationModule': {'nctId': 'NCT02992366', 'briefTitle': ': SOCKET SHIELD TECHNIQUE VERSUS EMPTY SOCKET TECHNIQUE', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'IMMEDIATE IMPLANT PLACEMENT IN THE ESTHETIC ZONE: SOCKET SHIELD TECHNIQUE VERSUS EMPTY SOCKET TECHNIQUE FOR PRESERVATION OF LABIAL ALVEOLAR BONE INTEGRITY', 'orgStudyIdInfo': {'id': 'Cairoshi-con'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'socket shield (A)', 'description': '1. Following local anesthetic infiltration opposite to the root to be extracted the root is sectioned in a mesiodistal direction along its long axis as far apical as possible.\n2. After sectioning the root into labial and palatal halves, the palatal half is removed with preservation of the labial root section.\n3. The labial half is prepared to be Flushing or 1mm above the labial alveolar crest. Then thinned slightly to a concave contour in an apico-coronal and mesiodistal direction.\n4. The implant will be inserted in place of the palatal half with the labial surface of the implant facing the labial root shield (root-implant interface)\n\nprimary closure will not be attempted as the patients will undergo immediate non-functioning provisionization.', 'interventionNames': ['Procedure: implant placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional immediate implant (B)', 'description': '1. Following local anesthetic infiltration opposite to the root to be extracted non traumatic extraction of the tooth or remaining root by periotome.\n2. The implant fixture will be inserted in the empty socket by conventional manner.\n\nprimary closure will not be attempted as the patients will undergo immediate non-functioning provisionization.', 'interventionNames': ['Procedure: implant placement']}], 'interventions': [{'name': 'implant placement', 'type': 'PROCEDURE', 'description': 'implant placement', 'armGroupLabels': ['conventional immediate implant (B)', 'socket shield (A)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed G. Khater, Bsc', 'role': 'CONTACT', 'email': 'drahmedgamalkhater@gmail.com', 'phone': '+201111717300'}, {'name': 'Mostafa I. Shindy, lecturer', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Mohamed Galal G. Beheiri, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'senior supervisor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Oral and Maxillofacial surgery resident in ministry of health', 'investigatorFullName': 'Ahmed Gamal Khater Ali', 'investigatorAffiliation': 'Cairo University'}}}}