Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-08 @ 5:45 PM
Study NCT ID:
NCT04195295
Status:
UNKNOWN
Last Update Posted:
2020-08-12
First Post:
2019-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, and Periosteum as Barrier Membrane Under Magnification
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2019-12-10', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone defect fill and density', 'timeFrame': '6 months', 'description': 'bone defect fill and bone density will be measured pre operatively and post operatively using CBCT'}], 'secondaryOutcomes': [{'measure': 'Probing pocket depth', 'timeFrame': '6 months', 'description': 'probing pocket depth is measured using UNC 15 probe pre operatively and post operatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrabony Periodontal Defect']}, 'descriptionModule': {'briefSummary': 'The prospective study is a interventional study to evaluate and compare the effectiveness of periosteal pedicle as grafting technique and egg shell derived nano hydroxyapatite as regenerative graft material for regeneration of intrabony defects.', 'detailedDescription': '30 Patients visiting the outpatient Department of Periodontology Krishnadevaraya College of Dental Sciences and Hospital, Bangalore will be enrolled for 6 month folllow up study based on the inclusion and exclusion criteria. Patients age ranged from 25 to 55 years. Patients with chronic periodontitis, with presence of intrabony defects with ≥6mm probing depth (PD), 2 or 3 wall defects are included in the study.\n\nThe patients are allocated to three goups through computer generated randomisation as:\n\nGroup A (n=10) - Egg shell derived nano hydroxyapatite (EnHA) graft and periosteal pedicle as barrier membrane.\n\nGroup B (n=10) - Only EnHA as graft. Group C (n=10) - An open flap debridement procedure only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients within the age group of 25 to 55 years.\n2. Patients with chronic periodontitis, with presence of intrabony defects with ≥6mm probing depth (PD), 2 or 3 wall defects as detected on CBCT.\n3. Gingival biotype \\>1.5mm\n4. Systemically healthy subjects.\n5. Patients who are compliant.\n6. Patients who had not received any periodontal treatment in the last six months.\n\nExclusion Criteria:\n\n1. Pregnant and Lactating females.\n2. Aggressive periodontitis.\n3. Presence of pulpal or periapical involvement.\n4. Patients with known systemic diseases and conditions precluding any elective surgery.\n5. Patients who were smokers.\n6. Teeth with poor prognosis.'}, 'identificationModule': {'nctId': 'NCT04195295', 'briefTitle': 'Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, and Periosteum as Barrier Membrane Under Magnification', 'organization': {'class': 'OTHER', 'fullName': 'Krishnadevaraya College of Dental Sciences & Hospital'}, 'officialTitle': 'Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, Derived From Egg Shell Along With Periosteum as Barrier Membrane Under Magnification - An Interventional Study', 'orgStudyIdInfo': {'id': '02_D012_102133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'periosteal membrane and egg shell graft', 'description': 'Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material and periosteal pedicle as barrier membrane.', 'interventionNames': ['Procedure: Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane']}, {'type': 'EXPERIMENTAL', 'label': 'only egg shell graft', 'description': 'Only Egg shell derived nano hydroxyapatite (EnHA) as graft material.', 'interventionNames': ['Procedure: Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'open flap debridement', 'description': 'open flap debridement procedure only.', 'interventionNames': ['Procedure: Open flap debridement procedure in intrabony defects.']}], 'interventions': [{'name': 'Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane', 'type': 'PROCEDURE', 'description': '* In group A, the full thickness mucoperiosteal flap will be elevated, which will be extended apically to expose sufficient amount of periosteum.\n* Periosteal membrane will be separated from the full thickness mucoperiosteal flap and released by one vertical incision mesially and one horizontal incision apically.\n* Posteriorly, the periosteum remained attached with the mucoperiosteal flap, so that blood supply could be maintained in the reflected periosteum.\n* Then the graft material will be packed into the defect.\n* Then periosteal membrane will be turned over the intrabony defect in such a way that the defect was completely covered by the periosteal membrane', 'armGroupLabels': ['periosteal membrane and egg shell graft']}, {'name': 'Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material', 'type': 'PROCEDURE', 'description': 'Full thickness mucoperiosteal flap will be raised and Vertical releasing incisions are used if necessary for better access to the surgical site. Then EnHA graft material will be placed into the defect before suturing the mucoperiosteal flap.', 'armGroupLabels': ['only egg shell graft']}, {'name': 'Open flap debridement procedure in intrabony defects.', 'type': 'PROCEDURE', 'description': 'full thickness mucoperiosteal flap will be raised, entire granulation tissue will be removed from the defects, the pocket epithelium was curetted from the inner surface of the flap, and the roots were thoroughly scaled and planed by means of manual and ultrasonic instruments. Then the operative area will be irrigated with sterile saline. After that, the mucoperiosteal flaps will be sutured.', 'armGroupLabels': ['open flap debridement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '562157', 'city': 'Bangalore', 'state': 'Karnataka', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Rashmi P, MDS', 'role': 'CONTACT', 'email': 'rashparams2005@yahoo.co.in', 'phone': '9900925844'}], 'facility': 'Krishnadevaraya college of dental sciences', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'centralContacts': [{'name': 'Dr. Rashmi P, MDS', 'role': 'CONTACT', 'email': 'rashprams2005@yahoo.co.in', 'phone': '9900925844'}, {'name': 'Dr. Sri Vani T. M, MDS', 'role': 'CONTACT', 'email': 'vani.tammina@gmail.com', 'phone': '9406443033'}], 'overallOfficials': [{'name': 'Dr. Rashmi P, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krishnadevaraya College of Dental Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Krishnadevaraya College of Dental Sciences & Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and HOD', 'investigatorFullName': 'Dr Prabhuji MLV', 'investigatorAffiliation': 'Krishnadevaraya College of Dental Sciences & Hospital'}}}}