Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT06646705
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-17
First Post:
2024-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biochemical Evaluation of Periodontal Effects of Orthodontic Treatment with Aligners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total amount of OPG in saliva', 'timeFrame': '24 hours after taking the clinical measurements', 'description': 'The total amount of osteoprotegerin in saliva'}], 'secondaryOutcomes': [{'measure': 'The total amount of RANKL in saliva', 'timeFrame': '24 hours after taking the clinical measurements', 'description': 'The total amount of receptor activator of NF-κB ligand in saliva'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aligner Treatment']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine the effect of orthodontic treatment with aligner on changes in osteoprotegerin (OPG) and receptor activator of NF-κB ligand (RANKL) levels in saliva samples and to investigate the possible relationship between periodontal clinical parameters. Materials and Methods: A total of 25 (n=25) saliva samples were taken from systemically healthy non-smoking individuals who were planned to receive orthodontic treatment with aligner before treatment. Whole mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded and repeated at 1 and 3 months. Enzyme-linked immunosorbent assay (ELISA) was used to determine OPG and RANKL levels in biological samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)\n* Must receive orthodontic treatment with aligners and must have accepted the treatment\n* Non-smoker\n* No medication for continuous use\n* Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.\n* Not in pregnancy or lactation period.\n\nExclusion Criteria:\n\n* Any oral or systemic disease\n* Regularly using a systemic medication\n* During pregnancy or lactation\n* Received periodontal treatment within the last 6 months.\n* Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months\n* Smokers are not included in the study'}, 'identificationModule': {'nctId': 'NCT06646705', 'briefTitle': 'Biochemical Evaluation of Periodontal Effects of Orthodontic Treatment with Aligners', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'Biochemical Evaluation of the Effect of Orthodontic Treatment with Aligner on Periodontal Parameters and OPG and RANKL Salivary Values', 'orgStudyIdInfo': {'id': '2022-GAP-DİŞF-0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aligner', 'description': 'Full-mouth clinical periodontal measurements recorded and saliva obtained', 'interventionNames': ['Diagnostic Test: Saliva obtaining']}], 'interventions': [{'name': 'Saliva obtaining', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.', 'armGroupLabels': ['Aligner']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35640', 'city': 'Izmir', 'state': 'Cigli', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Katip Çelebi University Faculty of Dentistry', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doç. Dr.', 'investigatorFullName': 'Burçin Akan', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}