Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-04 @ 11:50 PM
Study NCT ID:
NCT03841851
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2019-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Implant Placement With Immediate Loading With and Without Connective Tissue Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Each patient will be given acode by the researcher and the observers will be blind to which group this case belong'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will be conducted on patients with badely decayed teeth in aesthetic zone and need immediate fixed restoration .\n\nThis study is to be conducted in Dental Implant Clinic, Faculty of Dentistry, Cairo University, Egypt.\n\nAll the patients will be entailed about the study and given their approval to participate on written consent.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pink esthetics', 'timeFrame': 'every 2 weeks for 3 months', 'description': 'evaluation of esthetic outcome using pink esthetic score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pateint With Badely Decayed Anterior Teeth']}, 'referencesModule': {'references': [{'pmid': '356184', 'type': 'BACKGROUND', 'citation': 'Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period. Scand J Plast Reconstr Surg Suppl. 1977;16:1-132. No abstract available.'}, {'pmid': '9468854', 'type': 'BACKGROUND', 'citation': 'Salama H, Salama MA, Li TF, Garber DA, Adar P. Treatment planning 2000: an esthetically oriented revision of the original implant protocol. J Esthet Dent. 1997;9(2):55-67. doi: 10.1111/j.1708-8240.1997.tb00919.x.'}, {'pmid': '3527955', 'type': 'BACKGROUND', 'citation': 'Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.'}, {'pmid': '2094653', 'type': 'BACKGROUND', 'citation': 'Adell R, Eriksson B, Lekholm U, Branemark PI, Jemt T. Long-term follow-up study of osseointegrated implants in the treatment of totally edentulous jaws. Int J Oral Maxillofac Implants. 1990 Winter;5(4):347-59.'}, {'pmid': '9274078', 'type': 'BACKGROUND', 'citation': 'Schnitman PA, Wohrle PS, Rubenstein JE, DaSilva JD, Wang NH. Ten-year results for Branemark implants immediately loaded with fixed prostheses at implant placement. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):495-503.'}, {'pmid': '15142089', 'type': 'BACKGROUND', 'citation': 'Testori T, Meltzer A, Del Fabbro M, Zuffetti F, Troiano M, Francetti L, Weinstein RL. Immediate occlusal loading of Osseotite implants in the lower edentulous jaw. A multicenter prospective study. Clin Oral Implants Res. 2004 Jun;15(3):278-84. doi: 10.1111/j.1600-0501.2004.01013.x.'}, {'pmid': '20111758', 'type': 'BACKGROUND', 'citation': 'Redemagni M, Cremonesi S, Garlini G, Maiorana C. Soft tissue stability with immediate implants and concave abutments. Eur J Esthet Dent. 2009 Winter;4(4):328-37.'}, {'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': '19922492', 'type': 'BACKGROUND', 'citation': 'Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Lindhe J. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin Oral Implants Res. 2010 Jan;21(1):13-21. doi: 10.1111/j.1600-0501.2009.01824.x. Epub 2009 Nov 18.'}, {'pmid': '22509794', 'type': 'BACKGROUND', 'citation': 'Cosyn J, Hooghe N, De Bruyn H. A systematic review on the frequency of advanced recession following single immediate implant treatment. J Clin Periodontol. 2012 Jun;39(6):582-9. doi: 10.1111/j.1600-051X.2012.01888.x. Epub 2012 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'extraction of badely decayed anterior teeth immediate implant placement with immediate temporaization', 'detailedDescription': 'Intra-operative procedure:\n\nLocal anesthesia will be injected intra-orally at the implant site. Atraumatic extraction of badley decayed teeth in the aesthetic area .\n\nFor group A :\n\ntraditional drilling for immediate implant placement . immediate temporization .\n\nFor group B :\n\ntraditional drilling for immediate implant placement . immediate temporization . subepithelial connective tissue graft from the palate .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-restorable maxillary anterior teeth indicated for implant placement.\n* Both sexes.\n* No intraoral soft and hard tissue pathology.\n* No systemic condition that contraindicate implant placement.\n\nExclusion Criteria:\n\n* Patients with systemic disease that may affect bone quality.\n* Patients with poor oral hygiene and active periodontal diseases.\n* Heavy smokers more than 20 cigarettes per day.'}, 'identificationModule': {'nctId': 'NCT03841851', 'briefTitle': 'Immediate Implant Placement With Immediate Loading With and Without Connective Tissue Graft', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Aesthetic Outcome of Immediate Implant Placement With Immediate Loading With and Without Sub Epithelial Connective Tissue Graft', 'orgStudyIdInfo': {'id': 'cairo univ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'temporization without soft tissue graft', 'description': '* Local anesthesia will be injected intra-orally at the implant site.\n* Atraumatic extraction of badley decayed teeth in the aesthetic area\n* traditional drilling for immediate implant placement .\n* immediate temporization .'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'temporization with soft tissue graft', 'description': '* Local anesthesia will be injected intra-orally at the implant site.\n* Atraumatic extraction of badley decayed teeth in the aesthetic area\n* traditional drilling for immediate implant placement .\n* immediate temporization .\n* subepithelial connective tissue graft from the palate .', 'interventionNames': ['Procedure: sub epithelial connective tissue graft']}], 'interventions': [{'name': 'sub epithelial connective tissue graft', 'type': 'PROCEDURE', 'description': '* Local anesthesia will be injected intra-orally at the implant site.\n* Atraumatic extraction of badley decayed teeth in the aesthetic area traditional drilling for immediate implant placement .\n* immediate temporization .\n* subepithelial connective tissue graft from the palate', 'armGroupLabels': ['temporization with soft tissue graft']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Local anesthesia will be injected intra-orally at the implant site. Atraumatic extraction of badley decayed teeth in the aesthetic area .\n\nFor group A :\n\n* traditional drilling for immediate implant placement .\n* immediate temporization .\n\nFor group B :\n\n* traditional drilling for immediate implant placement .\n* immediate temporization .\n* subepithelial connective tissue graft from the palate'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator(doctor)', 'investigatorFullName': 'Mohamed Habib', 'investigatorAffiliation': 'Cairo University'}}}}