Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-13 @ 3:39 PM
Study NCT ID:
NCT05258006
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2022-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Autogenous Dentin Graft in Treatment of Infra-bony Defect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-22', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vertical bone loss', 'timeFrame': '6 months', 'description': 'vertical bone loss was measured from cementoenamel junction (CEJ) to the base of the bone defect in each site in group I \\& II.'}, {'measure': 'Clinical attachment level', 'timeFrame': '6 months', 'description': 'Clinical attachment level was measured at baseline and 6 months'}, {'measure': 'Probing pocket depth', 'timeFrame': '6 months', 'description': 'Probing pocket depth was measured at baseline and 6 months'}, {'measure': 'Bone gain', 'timeFrame': '6 months', 'description': 'The bone gain is calculated by:\n\n* Preoperative VBL (at baseline): measured as the distance from cementoenamel junction (CEJ) to the base of the bone defect.\n* Postoperative VBL (after 6 months) measured as the distance from cementoenamel junction (CEJ) to the base of the bone formation.\n* Postoperative bone fill (bone gain after 6 months) \\[measured by subtracting the preoperative VBL from the postoperative VBL\\].'}], 'secondaryOutcomes': [{'measure': 'Plaque Index', 'timeFrame': '6 months', 'description': 'plaque index was measured at baseline, 3, 6 months'}, {'measure': 'Gingival index', 'timeFrame': '6 months', 'description': 'Gingival index was measured at baseline, 3, 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis (Stage 3)']}, 'referencesModule': {'references': [{'pmid': '37482878', 'type': 'DERIVED', 'citation': 'Elgendy EA, Elgendy AM, ElBorady OM. Clinical And Radiographic Assessment Of Autogenous Dentin Nanoparticles In Treatment Of Stage Iii Periodontitis: A Split-Mouth Clinical Study. J Pak Med Assoc. 2023 Apr;73(Suppl 4)(4):S310-S316. doi: 10.47391/JPMA.EGY-S4-60.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to evaluate the effect of demineralized autogenous dentine on treatment of infrabony defects.', 'detailedDescription': 'In this study, the investigators tested the effect of demineralized autogenous dentine as a bone graft in treatment of stage III periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and bone gain in defect sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with good systemic health and no contraindication for periodontal surgery.\n* Patients who are able to maintain good oral hygiene.\n* Gingival thickness for the site selected should be ≥1mm.\n* Probing depth of ≥ 6mm.\n* Patient has at least one hopeless teeth\n\nExclusion Criteria:\n\n* Active infectious diseases (hepatitis, tubercu¬losis, HIV, etc….).\n* Medically compromised patients.\n* Smokers and alcoholic abusers\n* People who suffer from any systemic disease that affect the periodontium.\n* Pregnant, postmenopausal women.\n* People who take anti-inflammatory drugs, anti¬biotics or vitamins within the previous 3 month.\n* People who use mouth washes regularly\n* Participants in other clinical trials.'}, 'identificationModule': {'nctId': 'NCT05258006', 'briefTitle': 'Assessment of Autogenous Dentin Graft in Treatment of Infra-bony Defect', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Clinical and Radiographic Assessment of Autogenous Dentin Nanoparticles in Treatment of Stage III Periodontitis: A Split-Mouth Clinical Study', 'orgStudyIdInfo': {'id': '4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Open flap debridement + allograft bone (Maxgraft)', 'interventionNames': ['Procedure: Autogenous demineralized dentin nanoparticles']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open flap debridement + Autogenous demineralized nanoparticles', 'interventionNames': ['Procedure: Autogenous demineralized dentin nanoparticles']}], 'interventions': [{'name': 'Autogenous demineralized dentin nanoparticles', 'type': 'PROCEDURE', 'description': 'Effect of Autogenous demineralized dentin nanoparticles in bone gain in infrabony defect', 'armGroupLabels': ['Open flap debridement + Autogenous demineralized nanoparticles', 'Open flap debridement + allograft bone (Maxgraft)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'October 6 University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Periodontology', 'investigatorFullName': 'Enas Elgendy', 'investigatorAffiliation': 'October 6 University'}}}}