Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-04 @ 8:46 AM
Study NCT ID:
NCT03633968
Status:
UNKNOWN
Last Update Posted:
2018-08-20
First Post:
2018-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Graftless Lateral Maxillary Sinus Lift Balloon by Different Antrostomy Sizes With Simultaneous Implant Placement
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'], 'maskingDescription': 'assessment of the effect of the antrostomy size in graftless lateral maxillary sinus floor elevation using AMBE (antral membrane balloon elevation) with simultaneous implant placement'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'assessment of the effect of the antrostomy size in graftless lateral maxillary sinus floor elevation using AMBE (antral membrane balloon elevation) with simultaneous implant placement'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2018-08-13', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of bone formation', 'timeFrame': 'after 6 months', 'description': 'measurement of amount of bone gained by using CBCT'}], 'secondaryOutcomes': [{'measure': 'implant stability', 'timeFrame': 'after 6 months', 'description': 'measurement of implant stability by using osstell'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sinus augmentation,lifting'], 'conditions': ['Atrophy of Edentulous Maxillary Alveolar Ridge']}, 'referencesModule': {'references': [{'pmid': '22117952', 'type': 'BACKGROUND', 'citation': 'Stern A, Green J. Sinus lift procedures: an overview of current techniques. Dent Clin North Am. 2012 Jan;56(1):219-33, x. doi: 10.1016/j.cden.2011.09.003.'}, {'pmid': '7994726', 'type': 'BACKGROUND', 'citation': 'Summers RB. The osteotome technique: Part 3--Less invasive methods of elevating the sinus floor. Compendium. 1994 Jun;15(6):698, 700, 702-4 passim; quiz 710.'}, {'pmid': '15871527', 'type': 'BACKGROUND', 'citation': 'Soltan M, Smiler DG. Antral membrane balloon elevation. J Oral Implantol. 2005;31(2):85-90. doi: 10.1563/0-773.1.'}, {'pmid': '20467595', 'type': 'BACKGROUND', 'citation': 'Esposito M, Grusovin MG, Rees J, Karasoulos D, Felice P, Alissa R, Worthington H, Coulthard P. Effectiveness of sinus lift procedures for dental implant rehabilitation: a Cochrane systematic review. Eur J Oral Implantol. 2010 Spring;3(1):7-26.'}, {'pmid': '25872947', 'type': 'BACKGROUND', 'citation': 'Watanabe T, Nakagawa E, Saito K, Ohshima H. Differences in Healing Patterns of the Bone-Implant Interface between Immediately and Delayed-Placed Titanium Implants in Mouse Maxillae. Clin Implant Dent Relat Res. 2016 Feb;18(1):146-60. doi: 10.1111/cid.12280. Epub 2015 Apr 15.'}, {'pmid': '23057039', 'type': 'BACKGROUND', 'citation': 'Avila-Ortiz G, Wang HL, Galindo-Moreno P, Misch CE, Rudek I, Neiva R. Influence of lateral window dimensions on vital bone formation following maxillary sinus augmentation. Int J Oral Maxillofac Implants. 2012 Sep-Oct;27(5):1230-8.'}, {'pmid': '23057031', 'type': 'BACKGROUND', 'citation': 'Testori T, Weinstein RL, Taschieri S, Del Fabbro M. Risk factor analysis following maxillary sinus augmentation: a retrospective multicenter study. Int J Oral Maxillofac Implants. 2012 Sep-Oct;27(5):1170-6.'}, {'pmid': '4500328', 'type': 'BACKGROUND', 'citation': 'Hatziotis JC, Papanayotou PH, Trigonidis G. Benign mesenchymoma of the tongue: report of case. J Oral Surg. 1972 Jan;30(1):45-6. No abstract available.'}, {'pmid': '18371101', 'type': 'BACKGROUND', 'citation': 'Barone A, Santini S, Marconcini S, Giacomelli L, Gherlone E, Covani U. Osteotomy and membrane elevation during the maxillary sinus augmentation procedure. A comparative study: piezoelectric device vs. conventional rotative instruments. Clin Oral Implants Res. 2008 May;19(5):511-5. doi: 10.1111/j.1600-0501.2007.01498.x. Epub 2008 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'two groups undergo for graftless sinus lift using AMBE (antral membrane balloon elevation) through different antrostomy size with simultaneous implant placement', 'detailedDescription': 'control group undergoes for graftless sinus lift using AMBE through large antrostomy with simultaneous implant placement. While, study group undergo for graftless sinus lift using AMBE through small antrostomy with simultaneous implant placement. the aim of the study is assessment the effect of antrostomy size on bone formation in graftless sinus lift with simultaneous implant placement.\n\nCBCT will be done before and after the surgery and after 6 months to assess of amount bone gain in mm.\n\nimplant stability after 6 months will be determined by using Osstell. Primary outcome: amount of bone gain which will be measured by using linear measurement from CBCT.\n\nsecondary outcome: stability of implant by using osstell'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with atrophic maxilla and pneumatization of maxillary sinus with residual bone height from 3-6mm.\n2. Both sexes\n3. No intraoral soft and hard tissue pathology,\n4. No systemic condition that contraindicate implant placement\n\nExclusion Criteria:\n\n1. Sinus pathology.\n2. Heavy smokers more than 20 cigarettes per day.\n3. Patients with systemic disease that may affect normal healing.\n4. Psychiatric problems.\n5. Disorders to implant are related to history of radiation therapy to head and neck neoplasia or bone augmentation to implant site'}, 'identificationModule': {'nctId': 'NCT03633968', 'briefTitle': 'Graftless Lateral Maxillary Sinus Lift Balloon by Different Antrostomy Sizes With Simultaneous Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of the Effect of the Antrostomy Size in Graftless Lateral Maxillary Sinus Floor Elevation Using AMBE (Antral Membrane Balloon Elevation) With Simultaneous Implant Placement', 'orgStudyIdInfo': {'id': 'maxillary sinus augmentation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'maxillary sinus lift small antrostomy', 'description': 'local anaesthesia will be given flap will be reflected to expose sinus lateral wall. round diamond bur will be used to make small antrostomy and expose schneiderian membrane.\n\nmaxillary sinus lift by using antral membrane balloon elevation without using graft material with simultaneous implant placement', 'interventionNames': ['Procedure: maxillary sinus lift']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'maxillary sinus lift large antrostomy', 'description': 'local anaesthesia will be given flap will be reflected to expose sinus lateral wall round diamond bur will be used to make large antrostomy and expose schneiderian membrane.\n\nmaxillary sinus lift by using antral membrane balloon elevation without using graft material with simultaneous implant placement', 'interventionNames': ['Procedure: maxillary sinus lift']}], 'interventions': [{'name': 'maxillary sinus lift', 'type': 'PROCEDURE', 'otherNames': ['implant placement'], 'description': 'maxillary sinus floor elevation by using balloon through either small or large antrostomy without using graft material with simultaneous implant placement', 'armGroupLabels': ['maxillary sinus lift large antrostomy', 'maxillary sinus lift small antrostomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'state': 'Al-Manial', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed a dahouk, BSD', 'role': 'CONTACT', 'email': 'ethics@dentistry.cu.edu.eg', 'phone': '01289847733'}, {'name': 'Ahmed Y dr khaleel', 'role': 'CONTACT', 'email': 'ahmed.zayed@dentistry.cu.edu.eg', 'phone': '01069617691'}], 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed a dahouk, BSD', 'role': 'CONTACT', 'email': 'a7madmo97@gmail.com', 'phone': '00201011862613', 'phoneExt': '00201289847733'}, {'name': 'Ahmed a dr khleel, BSD', 'role': 'CONTACT', 'email': 'ethics@dentistry.cu.edu.eg', 'phone': '0223642705'}], 'overallOfficials': [{'name': 'ahmed a dahouk, bsd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'web sites and journals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ahmed mohammed khalil aldahouk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator(doctor)', 'investigatorFullName': 'ahmed mohammed khalil aldahouk', 'investigatorAffiliation': 'Cairo University'}}}}