Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:36 PM
Study NCT ID:
NCT07460869
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare Between the Effect of CGF and PRF on Revascularization of Immature Roots of the Mandibular Permanent First Molar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-10', 'size': 250507, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-19T23:21', 'hasProtocol': True}, {'date': '2025-07-28', 'size': 539753, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-03-04T17:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'parallel randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'root growth', 'timeFrame': '18 months', 'description': 'change root length'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CGF and PRF'], 'conditions': ['Revascularization of Immature Young Permenant Teeth']}, 'descriptionModule': {'briefSummary': 'in this study investigators do revascularization technique to promote root growth of immature mandibular first permanent molar by using CGF and PRF from blood sample of patients', 'detailedDescription': 'children 6-8 yrs were selected for this study because the roots of mandibular first permanent molar is not completed. then access cavity is opened, irrigation protocol is applied, intracanal medication is applied and the cavity is sealed with temporary filling. after three weeks blood sample is obtained from patients to get CGF and PRF membranes. temporary filling is removed . intracanal medication is removed, over instrumentation is done to get some intracanal blood the wait tell blood clot is formed then CGF or PRF is applied on the clot the bio dentine is applied and cavity is sealed with composite restoration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with immature necrotic lower fitrst permanent molar.\n* No history of repeated pathosis or cellulitis.\n* Patients accept the treatment modality.\n* Patient-free from systemic, allergic or genetic problems.\n\nExclusion Criteria:\n\n* Tooth mobility.\n* Teeth with non-restorable crowns.\n* Children with facial cellulitis\n* Children with draining fistula\n* Children with a history of recurrent preapical pathosis'}, 'identificationModule': {'nctId': 'NCT07460869', 'briefTitle': 'Compare Between the Effect of CGF and PRF on Revascularization of Immature Roots of the Mandibular Permanent First Molar', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Concentrated Growth Factor Versus Platelets-rich Fibrin in Revascularization of Immature Necrotic Mandibular First Permanent Molar.', 'orgStudyIdInfo': {'id': 'Bothaina A. Gado'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CGF and biodentine arm', 'description': '(control group) Which CGF and bio-dentine are applied to the immature pulp of the first permanent molar', 'interventionNames': ['Biological: Revascularization/Conservative management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PRF and biodentine arm', 'description': 'PRF and bio-dentine are applied on immature pulp of first permanent molar', 'interventionNames': ['Biological: Revascularization/Conservative management']}], 'interventions': [{'name': 'Revascularization/Conservative management', 'type': 'BIOLOGICAL', 'description': 'Compare the effect of CGF and PRF in the revascularization of immature mandibular first permanent molar using bio-dentine', 'armGroupLabels': ['CGF and biodentine arm', 'PRF and biodentine arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2422998', 'city': 'Minya', 'state': 'Minya Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry Minya University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Ahmed elheeny, professor of Pediatric and Com', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'unaffilliaed'}]}, 'ipdSharingStatementModule': {'url': 'https://www.minia.edu.eg', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '2027', 'ipdSharing': 'YES', 'description': 'CONCENTRATED GROWTH FACTOR VERSUS PLATELETS-RICH FIBRIN IN REVASCULARIZATION OF IMMATURE NECROTIC MANDIBULAR FIRST PERMANENT MOLAR', 'accessCriteria': 'dental students and researchers in denta field'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer in Pediatric and Community Department, South Valley University Faculty of Dentistry', 'investigatorFullName': 'Bothaina Ahmed', 'investigatorAffiliation': 'Minia University'}}}}