Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
Study NCT ID:
NCT07265804
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2025-11-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PRF and CGF Scaffolds With EDTA in Regeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003790', 'term': 'Dental Pulp Necrosis'}, {'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001777', 'term': 'Blood Coagulation'}, {'id': 'D004492', 'term': 'Edetic Acid'}, {'id': 'D056690', 'term': 'Prolactin-Releasing Hormone'}], 'ancestors': [{'id': 'D006487', 'term': 'Hemostasis'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No blinding was possible because the type of scaffold (blood clot, PRF, or CGF) and the EDTA concentration (5% or 17%) were visibly identifiable during the clinical procedure. Operators could not be masked, and participants were aware of the treatment steps, making the study open label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study used a parallel-group interventional model in which 30 immature permanent teeth diagnosed with pulp necrosis were randomly assigned to six treatment arms. Each participant received only one intervention, consisting of one scaffold type (blood clot, PRF, or CGF) combined with either 5% or 17% EDTA as the final irrigant. All groups were treated and followed simultaneously, and no crossover occurred between interventions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Root Length Increase', 'timeFrame': 'Baseline to 12 months', 'description': 'Increase in root length measured using cone-beam computed tomography (CBCT).'}], 'secondaryOutcomes': [{'measure': 'Apical Diameter Change (Apical Closure)', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in apical diameter measured by CBCT, used to evaluate apical closure after regenerative treatment.'}, {'measure': 'Periapical Lesion Volume Reduction', 'timeFrame': 'Baseline to 12 months', 'description': 'Volumetric reduction in periapical radiolucency measured by CBCT segmentation.'}, {'measure': 'Hard Tissue Formation Volume', 'timeFrame': 'Baseline to 12 months', 'description': 'Increase in newly formed mineralized tissue volume assessed by CBCT 3D segmentation.'}, {'measure': 'Pulp Sensitivity Response', 'timeFrame': '12 months', 'description': 'Presence or absence of a positive response to cold testing and electric pulp testing (EPT).'}, {'measure': 'Clinical Healing', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': 'Absence of pain, swelling, sinus tract, and percussion sensitivity during follow-up examinations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Regenerative Endodontics', 'Platelet-Rich Fibrin', 'Concentrated Growth Factor', 'Blood Clot Scaffold', 'EDTA Irrigation'], 'conditions': ['Pulp Necrosis', 'Immature Permanent Teeth', 'Open Apex', 'Periapical Periodontitis', 'Procedure']}, 'descriptionModule': {'briefSummary': 'This study evaluated the regenerative outcomes of immature permanent teeth with necrotic pulps treated using three scaffold types-blood clot, platelet-rich fibrin (PRF), and concentrated growth factor (CGF)-combined with either 5% or 17% EDTA as the final irrigant. Thirty teeth were randomly assigned to six treatment groups and followed clinically and radiographically for 12 months. Cone-beam computed tomography (CBCT) was used to assess root development parameters, including root length increase, apical diameter change, hard tissue formation, and periapical lesion volume. Clinical assessments included pain, swelling, sinus tract formation, percussion sensitivity, and pulp sensitivity testing. The study aimed to determine whether different scaffold materials and EDTA concentrations influence regenerative healing responses in immature necrotic teeth.', 'detailedDescription': 'This prospective randomized clinical study investigated regenerative endodontic treatment approaches for immature permanent teeth diagnosed with pulp necrosis and associated periapical pathology. Thirty teeth were allocated into six treatment subgroups based on two variables: scaffold type (blood clot, platelet-rich fibrin \\[PRF\\], or concentrated growth factor \\[CGF\\]) and final irrigation protocol (5% EDTA or 17% EDTA). All procedures were performed using a standardized regenerative protocol that included sodium hypochlorite irrigation, intracanal antibiotic medication, induction of apical bleeding when applicable, placement of the assigned scaffold, coronal sealing with mineral trioxide aggregate (MTA), and final composite restoration.\n\nRadiographic evaluation involved cone-beam computed tomography (CBCT) at baseline and 12 months to measure root length development, apical diameter changes, hard tissue formation, and volumetric alterations in periapical lesions. Periapical radiographs were taken at baseline, 6 months, and 12 months to complement CBCT findings. Clinical follow-up included assessment of symptoms such as pain, swelling, sinus tract presence, tenderness to percussion, and pulp sensitivity using cold testing and electric pulp testing.\n\nThe primary aim of this study was to compare the effects of scaffold type and EDTA concentration on the biological and radiographic outcomes of regenerative endodontic treatment. The study sought to clarify how these variables may influence root maturation, apical closure, pulp vitality responses, and periapical tissue healing within a regenerative framework. This research was designed to contribute to the optimization of clinical protocols for managing immature teeth with necrotic pulps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Immature permanent teeth with open apices\n* Diagnosis of pulp necrosis\n* Radiographic evidence of periapical pathology\n* Teeth suitable for isolation and restoration\n* Patients aged 9 to 25 years\n* No systemic diseases that contraindicate dental treatment\n* Willingness to attend follow-up visits\n* Signed informed consent by patient or guardian\n\nExclusion Criteria:\n\n* Teeth with root fractures\n* Teeth with severe canal curvature (\\>30°)\n* Teeth with advanced root resorption\n* Periodontal pocket depth \\>3 mm\n* Previous endodontic treatment or retreatment\n* Pregnancy\n* Use of antibiotics or analgesics within the last 7 days\n* Nonrestorable crowns\n* Uncooperative patients unable to attend follow-up'}, 'identificationModule': {'nctId': 'NCT07265804', 'acronym': 'RET-EDTA-CGF', 'briefTitle': 'PRF and CGF Scaffolds With EDTA in Regeneration', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Current Regenerative Approaches Applied to Immature Teeth With Necrotic Pulps', 'orgStudyIdInfo': {'id': 'RET-EDTA-Study-2024'}, 'secondaryIdInfos': [{'id': '2024/3-14 D', 'type': 'OTHER_GRANT', 'domain': 'Scientific Research Projects Unit of KSU,Turkey'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood Clot + 5% EDTA', 'description': 'Standard regenerative endodontic treatment using final irrigation with 5% EDTA followed by induction of bleeding to form a blood clot scaffold.', 'interventionNames': ['Procedure: Blood Clot + 5% EDTA']}, {'type': 'EXPERIMENTAL', 'label': 'Blood Clot + 17% EDTA', 'description': 'Regenerative endodontic procedure using final irrigation with 17% EDTA and blood clot scaffold formation.', 'interventionNames': ['Procedure: Blood Clot + 17% EDTA']}, {'type': 'EXPERIMENTAL', 'label': 'PRF + 5% EDTA', 'description': 'Regenerative endodontic procedure using platelet-rich fibrin scaffold after final irrigation with 5% EDTA.', 'interventionNames': ['Procedure: PRF + 5% EDTA']}, {'type': 'EXPERIMENTAL', 'label': 'PRF + 17% EDTA', 'description': 'Regenerative endodontic procedure using platelet-rich fibrin scaffold following final irrigation with 17% EDTA.', 'interventionNames': ['Procedure: PRF + 17% EDTA']}, {'type': 'EXPERIMENTAL', 'label': 'CGF + 5% EDTA', 'description': 'Regenerative endodontic protocol using concentrated growth factor scaffold after final irrigation with 5% EDTA.', 'interventionNames': ['Procedure: CGF + 5% EDTA']}, {'type': 'EXPERIMENTAL', 'label': 'CGF + 17% EDTA', 'description': 'Regenerative endodontic procedure using concentrated growth factor scaffold following final irrigation with 17% EDTA.', 'interventionNames': ['Procedure: CGF + 17% EDTA']}], 'interventions': [{'name': 'Blood Clot + 5% EDTA', 'type': 'PROCEDURE', 'description': 'Final irrigation with 5% EDTA followed by induction of apical bleeding to form an intracanal blood clot scaffold as part of the regenerative endodontic procedure.', 'armGroupLabels': ['Blood Clot + 5% EDTA']}, {'name': 'Blood Clot + 17% EDTA', 'type': 'PROCEDURE', 'description': 'Final irrigation with 17% EDTA followed by controlled induction of bleeding beyond the apex to produce a blood clot scaffold for regenerative endodontic treatment.', 'armGroupLabels': ['Blood Clot + 17% EDTA']}, {'name': 'PRF + 5% EDTA', 'type': 'PROCEDURE', 'description': 'Application of platelet-rich fibrin (PRF) scaffold after final irrigation with 5% EDTA during regenerative endodontic therapy.', 'armGroupLabels': ['PRF + 5% EDTA']}, {'name': 'PRF + 17% EDTA', 'type': 'PROCEDURE', 'description': 'Use of platelet-rich fibrin (PRF) scaffold following final irrigation with 17% EDTA in regenerative endodontic treatment.', 'armGroupLabels': ['PRF + 17% EDTA']}, {'name': 'CGF + 5% EDTA', 'type': 'PROCEDURE', 'description': 'Placement of concentrated growth factor (CGF) scaffold after final irrigation with 5% EDTA as part of the regenerative endodontic protocol.', 'armGroupLabels': ['CGF + 5% EDTA']}, {'name': 'CGF + 17% EDTA', 'type': 'PROCEDURE', 'description': 'Placement of concentrated growth factor (CGF) scaffold following final irrigation with 17% EDTA during regenerative endodontic treatment.', 'armGroupLabels': ['CGF + 17% EDTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Kahramanmaraş', 'country': 'Turkey (Türkiye)', 'facility': 'Kahramanmaraş Sütçü İmam University, Faculty of Dentistry', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}], 'overallOfficials': [{'name': 'Aliye Kamalak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Endodontics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD), including CBCT images and clinical records, will not be shared due to patient confidentiality and ethical restrictions stated by the institutional review board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Aliye Kamalak', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}