Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-31 @ 8:34 PM
Study NCT ID:
NCT04824235
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2021-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alveolar Ridge Preservation Using Amniotic Chorion Membrane
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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-04', 'studyFirstSubmitDate': '2021-03-20', 'studyFirstSubmitQcDate': '2021-03-27', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bucco-lingual bone width', 'timeFrame': 'at baseline, 1 months and 4 months', 'description': 'Bone width will be measured using bone caliper and radiographically'}, {'measure': 'Change in Corono-apical bone height', 'timeFrame': 'at baseline, 1 months and 4 months', 'description': 'Bone height using a pre-fabricated stent.'}, {'measure': 'total bone volume change', 'timeFrame': 'at baseline, and 4 months', 'description': 'It will be evaluated by the use of 3D scans of patient dental models'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alveolar Ridge Preservation']}, 'descriptionModule': {'briefSummary': 'the present study is to compare the amniotic chorion membrane (ACM) alone versus the amniotic chorion membrane combined with xenograft for their efficacy in alveolar ridge preservation procedures regarding volumetric changes assessed by cone beam computed tomography (CBCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients require extraction of a non-restorable (premolar or anterior tooth) located in the maxillary arch and needs implant restoration.\n* Type two sockets will be selected as revealed by Cone beam computed tomography(CBCT)\n* Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index\n* Male and female within age range of 20-45 years.\n\nExclusion Criteria:\n\n* Smokers.\n* Patients with poor oral hygiene or non-compliant patients who are not willing to perform oral hygiene measures.\n* Pregnant and breast-feeding females.\n* Patients with acute peri-apical infection or sinus tract.\n* Vulnerable group of patients as handicapped patients, orphans,prisoners,etc'}, 'identificationModule': {'nctId': 'NCT04824235', 'briefTitle': 'Alveolar Ridge Preservation Using Amniotic Chorion Membrane', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Alveolar Ridge Preservation Using Amniotic Chorion Membrane Alone or Combined With Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)', 'orgStudyIdInfo': {'id': 'alveolar preservation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amnoitic Chorion Membrane and xenograft', 'description': 'extraction sockets where ridge preservation will be performed using Chorion Membrane with Xenograft', 'interventionNames': ['Other: Amniotic Chorion Membrane and Bio-Oss xenograft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amnoitic Chorion Membrane only', 'description': 'extraction sockets where ridge preservation will be performed using Chorion Membrane Alone', 'interventionNames': ['Other: Amniotic Chorion Membrane only']}], 'interventions': [{'name': 'Amniotic Chorion Membrane and Bio-Oss xenograft', 'type': 'OTHER', 'description': 'Bioxclude Amniotic Chorion Membrane with xenograft (Bio-Oss) for ridge preservation', 'armGroupLabels': ['Amnoitic Chorion Membrane and xenograft']}, {'name': 'Amniotic Chorion Membrane only', 'type': 'OTHER', 'description': 'Bioxclude Amniotic Chorion Membrane only', 'armGroupLabels': ['Amnoitic Chorion Membrane only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}