Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-29 @ 12:36 PM
Study NCT ID:
NCT04669795
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2020-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070631', 'term': 'Diastasis, Bone'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone gain after distraction', 'timeFrame': 'immediately at end of distractor activation', 'description': 'Increase in bone height after distraction'}, {'measure': 'Relapse after distraction', 'timeFrame': '3 months from beginning of consolidation period', 'description': 'Relapse evaluated on panorama'}, {'measure': 'Crestal bone loss around dental implant', 'timeFrame': '6 months from implant placement', 'description': 'By using cone beam CT, crestal bone level around implant evaluated by measuring a distance from implant apex to a point on dental implant where bone contacts the dental implant mesially and distally. then average of bone loss round each implant was obtained.'}, {'measure': 'Bone density around dental implant', 'timeFrame': '6 months from implant placement', 'description': 'By using cone beam CT, bone density assessed around dental implant at crestal, middle, and apical portions then average was obtained'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alveolar', 'Bone', 'Distraction'], 'conditions': ['Distraction of Bone', 'Dental Implant']}, 'referencesModule': {'references': [{'pmid': '34607598', 'type': 'DERIVED', 'citation': 'Altaweel AA, Baiomy AABA, Shoshan HS, Abbas H, Abdel-Hafiz AA, Gaber AE, Zewail AA, Elshiekh MAM. Evaluation of osteogenic potential of Cissus quadrangularis on mandibular alveolar ridge distraction. BMC Oral Health. 2021 Oct 4;21(1):491. doi: 10.1186/s12903-021-01847-y.'}]}, 'descriptionModule': {'briefSummary': 'Deficient alveolar mandibular ridge corrected distraction osteogenesis to facilitate dental implant placement. Patients grouped into 2 groups: one group received Cissus quadrangularis during the consolidation period, and the other group received placebo.', 'detailedDescription': 'OPGs were taken immediately after distractor placement, at end of activation period, at 1st,2nd month of consolidation period, and at end of consolidation period. Change in bone height was evaluated immediately after distractor placement, at end of activation and end of consolidation periods.\n\nCBCT were taken immediately after implant installation, and 6 months later to evaluate change bone density and marginal bone level about the dental implant.\n\nhistological evaluation was done by biopsy obtained, by trephine bur, from implant site during its preparation. The bone biopsy fixed in 4% formalin solution for 7 days, rinsed in water, and dehydrated in sequent phases of ethanol (70, 80, 90, and 100%) and then specimens were stained by hematoxylin- eosin for microscopic evaluation.\n\nRadiographic evaluation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were included if they were free from any disease that may affect healing. Also, presented with 2-3 missing teeth at least in posterior area and CBCT showed bone height above inferior alveolar canal (IAC) ranged 8-10mm.\n\nExclusion Criteria:\n\n* patients were excluded if they suffered from any disease affect tissue healing, bad oral hygiene or heavy smoking patients'}, 'identificationModule': {'nctId': 'NCT04669795', 'briefTitle': 'Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of Osteogenic Potential of Cissus Quadrangularis on Mandibular Alveolar Ridge Distraction', 'orgStudyIdInfo': {'id': 'Al-AlAzhar University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1', 'description': 'Placebo was given to ten patients during consolidation period ( 2 capsule daily for 6 months during consolidation period)', 'interventionNames': ['Drug: Cissus Quadrangularis']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Cissus quadrangularis in form of capsules given to ten patients ( 2 capsule daily for 6 months during consolidation period)', 'interventionNames': ['Drug: Cissus Quadrangularis']}], 'interventions': [{'name': 'Cissus Quadrangularis', 'type': 'DRUG', 'otherNames': ['Hadiod capsule'], 'description': 'Drug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11651', 'city': 'Cairo', 'state': 'Nasr City', 'country': 'Egypt', 'facility': 'Faculty of dental medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Altaweel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Alharby university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Alaa Altaweel', 'investigatorAffiliation': 'Al-Azhar University'}}}}