Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT05724251
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2023-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Iodine Deficiency on Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'urine of participants'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'iodine deficiency', 'timeFrame': '0-1 hours of the diagnosis', 'description': 'iodine level of participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontitis', 'Iodine Deficiency'], 'conditions': ['Periodontal Diseases', 'Periodontitis', 'Iodine Deficiency', 'Periodontitis, Adult']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare urine iodine levels of participants with/without periodontitis.\n\nThe main question it aims to answer is there a relationship between iodine levels of urine and periodontitis.\n\nParticipants will give urine samples without any intervention.', 'detailedDescription': 'Periodontitis is a chronic, inflammatory disease with a cyclical course with active and passive periods, which may result in the destruction of gingival fibers, resorption of alveolar bone, and subsequent tooth loss, by spreading the inflammatory event that started in the gingiva to the tissues supporting the tooth as a result of the effects of bacteria. The disease is closely associated with many systemic conditions. These conditions include diabetes, cardiovascular diseases, respiratory diseases, birth complications, pregnancy, puberty.\n\nIodine deficiency is an important public health problem by affecting 10-15% of the population due to the diseases it causes. Iodine deficiency affects individuals of all ages. When the daily iodine requirement cannot be met, a group of mental, physical and developmental retardation symptoms called "Iodine deficiency disorders" (IEB) (Iodine deficiency disorders-IDD) occur. With the obligatory iodization of table salt, which started in 1998 in order to eliminate iodine deficiency in Turkey, this problem has been tried to be combated by switching to iodized salt consumption.\n\nThe study material was used by 73 adult individuals who applied to Atatürk University Faculty of Dentistry, Department of Periodontology for different reasons {1. group (H): periodontally healthy individuals, group 2 (P): individuals with periodontitis}. Urine samples will be collected from the participants without any periodontal intervention. Iodine levels in the urine will be studied.\n\nThere are studies in the literature to determine iodine deficiency and to determine the population periodontal disease status; however, there are no studies evaluating the possible relationship between iodine deficiency and periodontitis.\n\nThe aim of this study; To evaluate the iodine levels detected in the urine samples of patients with periodontitis by comparing them with healthy controls, and to investigate the possible role of iodine deficiency in the pathogenesis of periodontitis or a simple marker of disease activity in the light of these findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'individuals who referred to Atatürk University, Department of Periodontology', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals should not have any systemic disease that may or may not require medication, including salivary gland pathologies, and not particularly thyroid organ pathologies.\n* Individuals have not been continuously treated with anti-inflammatory, antioxidant or similar drugs in the last 6 months,\n* Individuals have not received periodontal treatment until 6 months ago,\n* Individuals must have at least 14 teeth\n* Patients diagnosed with stage 3 periodontitis\n\nExclusion Criteria:\n\n* Having a systemic disease such as cardiovascular, diabetes, hypertension, thyroid organ pathologies, chronic kidney failure\n* Being pregnant/breastfeeding\n* Being on medication for any reason\n* Being a smoker/tobacco user\n* Having another periodontal disease other than periodontitis\n* Having a chronic inflammatory disease (COPD, asthma)'}, 'identificationModule': {'nctId': 'NCT05724251', 'briefTitle': 'Effect of Iodine Deficiency on Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Effect of Iodine Deficiency on Periodontitis', 'orgStudyIdInfo': {'id': '9375'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'participants without periodontitis', 'interventionNames': ['Other: healthy']}, {'label': 'periodontitis', 'description': 'participants with stage-3 periodontitis', 'interventionNames': ['Other: periodontitis']}], 'interventions': [{'name': 'healthy', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Healthy']}, {'name': 'periodontitis', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240_', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'DİDEM ÖZKAL EMİNOĞLU', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ataturk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Didem OZKAL EMINOGLU', 'investigatorAffiliation': 'Ataturk University'}}}}