Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 5:09 AM
Study NCT ID:
NCT07488403
Status:
COMPLETED
Last Update Posted:
2026-03-23
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Mandibular Bone Microstructure Changes After Periodontal Treatment (M-BONE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mandibular Bone Microstructure Assessed by Fractal Dimension', 'timeFrame': 'Baseline and 6 months after treatment', 'description': 'Fractal dimension values obtained from predefined regions of interest on periapical and panoramic radiographs to evaluate changes in mandibular trabecular bone microstructure before treatment and 6 months after non-surgical periodontal therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fractal Dimension Alveolar Bone Periodontitis Gingivitis Mandible Mandibular Bone Fractal Analysis Trabecular Bone'], 'conditions': ['Periodontitis Gingivitis']}, 'descriptionModule': {'briefSummary': 'This retrospective study evaluates how non-surgical treatment for gum disease affects the bone of the mandible. Gum disease (periodontitis) can lead to changes in the bone supporting the teeth, but these changes are not always easy to detect with routine clinical examination.\n\nPreviously collected clinical and radiographic data from patients with moderate and severe gum disease (Stage II and Stage III periodontitis), as well as individuals with gingivitis, were analyzed. All participants had received standard periodontal treatment as part of routine care. Radiographic images taken before treatment and 6 months after treatment were examined using fractal analysis, a method used to assess bone structure.\n\nThe results of this study may help improve understanding of how periodontal treatment influences bone structure and may support the use of radiographic analysis as a tool for monitoring treatment outcomes.', 'detailedDescription': 'Periodontitis is a chronic inflammatory disease that leads to the destruction of the supporting structures of the teeth, including alveolar bone. Assessing changes in bone microstructure is important for understanding disease progression and treatment outcomes. Conventional clinical parameters may not fully reflect subtle alterations in trabecular bone architecture. Therefore, radiographic analysis methods, such as fractal analysis, have been proposed as objective tools to evaluate bone structure.\n\nThis retrospective observational study was conducted using previously collected clinical and radiographic data from patients treated at the Department of Periodontology, Akdeniz University Faculty of Dentistry. The study included patients diagnosed with Stage II and Stage III periodontitis, as well as individuals with gingivitis serving as a control group. All participants received non-surgical periodontal therapy as part of routine clinical care.\n\nPeriapical and panoramic radiographic images obtained at baseline and 6 months after treatment were analyzed. Fractal dimension analysis was performed on predefined regions of interest to assess changes in trabecular bone microstructure. In addition to radiographic evaluation, clinical periodontal parameters, including probing pocket depth, clinical attachment level, bleeding on probing, and plaque index, were recorded.\n\nThe primary objective of the study is to evaluate changes in mandibular bone microstructure following non-surgical periodontal therapy. Secondary objectives include assessing the relationship between radiographic findings and clinical periodontal parameters. The findings may contribute to a better understanding of bone response to periodontal treatment and support the use of fractal analysis as a quantitative tool in periodontal research and clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '70 Months', 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated at the Department of Periodontology, Akdeniz University Faculty of Dentistry, with available clinical and radiographic records suitable for retrospective evaluation. The study population includes individuals diagnosed with Stage II and Stage III periodontitis, as well as individuals with gingivitis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18 years and older\n\nPatients diagnosed with Stage II or Stage III periodontitis, or gingivitis\n\nPatients who received non-surgical periodontal therapy\n\nAvailability of complete clinical periodontal records\n\nAvailability of periapical and panoramic radiographs at baseline and 6 m\n\nExclusion Criteria:\n\n* Patients with systemic diseases affecting bone metabolism\n\nHistory of periodontal treatment within the last 6 months\n\nUse of medications affecting bone metabolism\n\nPregnant or lactating individuals\n\nPoor quality or missing radiographic records'}, 'identificationModule': {'nctId': 'NCT07488403', 'briefTitle': 'Evaluation of Mandibular Bone Microstructure Changes After Periodontal Treatment (M-BONE Study)', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Evaluation of Mandibular Bone Microstructure Changes After Non-Surgical Periodontal Therapy Using Fractal Analysis', 'orgStudyIdInfo': {'id': 'TBAEK-283'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stage II Periodontitis', 'description': 'Patients diagnosed with Stage II periodontitis who received non-surgical periodontal therapy.'}, {'label': 'Stage III Periodontitis', 'description': 'Patients diagnosed with Stage III periodontitis who received non-surgical periodontal therapy.'}, {'label': 'Gingivitis', 'description': 'Individuals with gingivitis who received routine periodontal care'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07700', 'city': 'Antalya', 'state': 'KONYAALTI', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University Faculty of Dentistry', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to privacy and confidentiality considerations related to retrospective clinical data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'association professor', 'investigatorFullName': 'Nezahat Arzu Kayar', 'investigatorAffiliation': 'Akdeniz University'}}}}