Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
Study NCT ID:
NCT03932357
Status:
UNKNOWN
Last Update Posted:
2021-08-20
First Post:
2019-04-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring Soft Tissue Thickness by CBCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2019-04-29', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cbct', 'timeFrame': '6 months', 'description': 'measuring soft tissue thickness using cbct in pig jaw'}], 'secondaryOutcomes': [{'measure': 'Acutal thickness measurement', 'timeFrame': '6 months', 'description': 'periodontal probe was inserted vertically into the soft tissue surface until resistance of the bone was felt\n\n. A rubber stop was placed in contact with the surface to facilitate the measurement of tissue thickness.actual thickness was measured with digital calipers'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cone Beam Computed Tomography']}, 'descriptionModule': {'briefSummary': 'accuracy of CBCT in measuring soft tissue thickness by using a radiopaque material as the real finding and measurements on pig jaws', 'detailedDescription': "* Pig jaws will be included in this study.\n* Soft tissue surfaces were lightly covered with barium sulfate powder using a powder spray. CBCT was taken.\n* A periodontal probe and a rubber stop were used for the measurement of trans-gingival probing thickness (TPT).\n* After that, flap were elevated, and actual thickness of soft-tissue (actual thickness, AT) was measured.\n\nThe Analytical phase:\n\n* In order to assess soft tissue thickness and bone levels an electronic digital caliper (Shenhan Measuring Tools Co., LTD, Shanghai) will used for measuring the transgingival probing thickness on the pig jaws.\n* A graduated Naber's probe will be used for measuring the transgingival probing thickness.\n\nSoft tissue thickness measurements:\n\n* Intra-observer variability was tested under the supervision of the director.\n* For the measurement of radiographic thickness (RT), wet soft tissue surfaces were covered with barium sulfate powder (SoloTop; Taejoon, Seoul, Korea), a radiopaque material used as a contrast medium.\n* A probes and rubber stop were used for the measurement of transgingival probing thickness (TPT).\n* A rubber stop was placed in contact with the surface to facilitate the measurement of tissue thickness, and then TPT was measured with digital calipers. All measurements were rounded to the nearest 0.01 mm.\n* For the measurement of actual thickness (AT), an incision was made onto each marked area. After flap elevation, actual soft tissue thickness was measured using the same method that was used for TPT.\n\nRadiographic examination\n\n* The pig jaws will then be imaged with CBCT.\n* CBCT scanning will be performed using a PROMAX R 3DMid CBCT device (Planmeca Oy, Helsinki, Finland) with scanning protocol 90 kVp, 8 mA and 13.58 seconds exposure time with a single 360 degree rotation ROMEXIS software. The jawes will be placed on the horizontal plate of the device. The midline and mandibular position will be adjusted using the laser guide"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'CBCT measuring soft tissue thickness using a radiopaque material', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study samples will not identified by age or gender group.\n* The selected pig jaw should be intact with no mechanical damage.\n* jaw with attached natural teeth\n\nExclusion Criteria:\n\n* Teeth with anomalies and fractures.\n* Periodontally affected teeth'}, 'identificationModule': {'nctId': 'NCT03932357', 'briefTitle': 'Measuring Soft Tissue Thickness by CBCT', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Accuracy of Cone Beam Computed Tomography in Measuring of Mandibular Pig Soft Tissue Thickness Using a Radiopaque Material in Comparesion With Real Measurement.Diagnostic Study', 'orgStudyIdInfo': {'id': 'Mahinaz Reda'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CBCT', 'type': 'RADIATION', 'description': 'measuring soft tissue thickness using a CBCT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11211', 'city': 'Cairo', 'state': 'Giza-elharam', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahinaz R Abdelhamed, master', 'role': 'CONTACT', 'email': 'dentist_m2012@hotmail.com', 'phone': '01005610622', 'phoneExt': '02'}, {'name': 'Mohamed A abas, master', 'role': 'CONTACT', 'email': 'dentist-86-2009@hotmail.com', 'phone': '01004100946', 'phoneExt': '02'}], 'facility': 'Mahinaz Reda Hassan', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'mahinaz R abdelhamed, master', 'role': 'CONTACT', 'email': 'dentist_m2012@hotmail.com', 'phone': '01005610622', 'phoneExt': '02'}, {'name': 'mohamed A abas, master', 'role': 'CONTACT', 'email': 'dentist-86-2009@hotmail.com', 'phone': '01004100946', 'phoneExt': '02'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'main supervisor Dr. Hoda Abd El Kader Saleh Professor, .Co-supervisor Dr: Walaa Abdelaty Associate Professor, Investigator: DR. Mahinaz Reda Hassan Assistant lecturer .', 'investigatorFullName': 'Mahinaz Reda Hassan Abdelhamed', 'investigatorAffiliation': 'Cairo University'}}}}