Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:28 PM
Study NCT ID:
NCT07466433
Status:
COMPLETED
Last Update Posted:
2026-03-12
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apical Preparation Size in Regenerative Endodontics of Mature Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-03-07', 'size': 75895, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-03-07T14:50', 'hasProtocol': True}, {'date': '2026-03-07', 'size': 68764, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2026-03-07T14:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-07', 'studyFirstSubmitDate': '2026-03-07', 'studyFirstSubmitQcDate': '2026-03-07', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primer success', 'timeFrame': '6 months and 12 months', 'description': 'Primer success is evaluated based on the absence of clinical symptoms and radiographic healing of the periapical lesion.'}, {'measure': 'Secondary success', 'timeFrame': '6 months and 12 months', 'description': 'Secondary success was defined as the recovery of pulp sensibility, evaluated using cold and electric pulp tests during follow-up examinations.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': 'baseline, day 1, day 2, and day 7 after treatment', 'description': 'Postoperative pain was evaluated using a visual analogue scale.'}, {'measure': 'Periapical Lesion Area', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Changes in the periapical lesion area were measured using digital radiographic analysis.'}, {'measure': 'Mean Gray Value', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Bone density changes in the periapical region were evaluated using mean gray value measurements obtained from digital radiographs.'}, {'measure': 'Fractal Dimension', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Changes in trabecular bone microarchitecture in the periapical region were evaluated using fractal dimension analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apical Periodontitis', 'Mature Teeth', 'Regenerative Endodontic Treatment']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn whether the size of apical preparation affects the success of regenerative endodontic treatment in mature permanent teeth with apical periodontitis. Regenerative endodontic treatment is a procedure that aims to eliminate infection and support healing of the tissues around the root of the tooth.\n\nThe main questions the study aims to answer are:\n\n* Does a larger apical preparation improve healing around the root tip?\n* Does apical preparation size affect pain after treatment or recovery of tooth vitality?\n\nResearchers compared two treatment approaches that use different apical preparation sizes to see if one leads to better clinical and radiographic healing.\n\nParticipants:\n\n* Received regenerative endodontic treatment with one of two apical preparation sizes\n* Attended follow-up visits for clinical examination and radiographic evaluation\n* Were monitored for pain and healing outcomes during the follow-up period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single-rooted mature teeth with periapical lesions\n* Teeth with a PAI score ≥ 3\n* Patients aged 18-45 years\n* Systemically healthy individuals\n* Patients who provided written informed consent\n\nExclusion Criteria:\n\n* Immature teeth\n* Previously root canal treated teeth\n* Teeth with a PAI score \\<3\n* Developmental anomalies\n* Advanced periodontal destruction\n* Internal/external resorption\n* History of trauma\n* Patients with systemic diseases\n* Pregnant or breastfeeding patients'}, 'identificationModule': {'nctId': 'NCT07466433', 'briefTitle': 'Apical Preparation Size in Regenerative Endodontics of Mature Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'The Effect of Apical Preperation Size on the Success of Regenerative Endodontic Treatment in Mature Teeth With Apical Periodontitis: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2024/13/877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MAF 40 group', 'description': 'Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 40.', 'interventionNames': ['Procedure: Regenerative Endodontic Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'MAF 80 group', 'description': 'Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 80.', 'interventionNames': ['Procedure: Regenerative Endodontic Treatment']}], 'interventions': [{'name': 'Regenerative Endodontic Treatment', 'type': 'PROCEDURE', 'description': 'Regenerative endodontic treatment (RET) is a biologically based procedure that includes root canal disinfection followed by placement of a biological scaffold to support tissue regeneration and periapical healing. In this study, the intervention differs according to the apical preparation size used (ISO 40 and ISO 80) in mature teeth with apical periodontitis.', 'armGroupLabels': ['MAF 40 group', 'MAF 80 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34854', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Faculty of Dentistry, Department of Endodontics', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}