Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:49 AM
Study NCT ID:
NCT07427095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Ultra-Processed Food Consumption and Oral Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultra-Processed Food Index (UPFI)', 'timeFrame': 'Day 1', 'description': 'This index system is a quantitative indicator used to measure the proportion of ultra-processed foods in the diets of individuals or populations. It is expressed as a score system and shows how much of the total daily energy intake comes from ultra-processed foods. It is usually calculated from dietary data of an individual or group.'}], 'secondaryOutcomes': [{'measure': 'Decayed Missing Filled Tooth (DMFT) Index', 'timeFrame': 'Day 1', 'description': 'D stands for decayed tooth'}, {'measure': 'Community Periodontal Index (CPI) Score', 'timeFrame': 'Day 1', 'description': 'The Community Periodontal Index (CPI) will be used to assess periodontal status. Gingival bleeding, calculus, and periodontal pocket depth will be assessed. Possible scores are as follows:\n\n0 - Healthy;\n\n1. \\- Bleeding after probing;\n2. \\- Calculus;\n3. \\- Pocket 4-5 mm;\n4. \\- Pocket 6 mm or greater. The highest CPI score for each sextant will be recorded from six tooth indices (16, 11, 26, 36, 31, and 46). Each tooth indices will be carefully measured using a mirror and a 0.5 mm ball-end WHO probe, applying a force of approximately 20 g.'}, {'measure': 'Age', 'timeFrame': 'Day 1', 'description': 'Age is a demographic variable representing the time elapsed since birth and is a fundamental determinant in the assessment of health outcomes.'}, {'measure': 'Waist Circumference', 'timeFrame': 'Day 1', 'description': 'Waist Circumference: The individual stands upright. A tape measure is taken horizontally at the narrowest point of the waist (usually between the bottom of the ribs and the top of the hipbone). It is expressed in cm.'}, {'measure': 'Gender', 'timeFrame': 'Day 1', 'description': 'Gender is a demographic variable referring to the biological classification of an individual as female or male.'}, {'measure': 'Weight satisfaction', 'timeFrame': 'Day 1', 'description': "Weight satisfaction is a psychosocial indicator reflecting an individual's subjective level of satisfaction with their current body weight."}, {'measure': 'Educational level', 'timeFrame': 'Day 1', 'description': 'Educational level is a sociodemographic indicator representing the highest level of formal education completed by an individual.'}, {'measure': 'Income level', 'timeFrame': 'Day 1', 'description': 'Income level is a socioeconomic indicator reflecting the economic status of an individual or household and influencing health behaviors and access to healthcare'}, {'measure': 'Smoking status', 'timeFrame': 'Day 1', 'description': 'Smoking status is a behavioral variable indicating the use of tobacco products and is a risk factor for numerous systemic and oral diseases.'}, {'measure': 'Toothbrushing frequency', 'timeFrame': 'Day 1', 'description': 'Toothbrushing frequency is an oral health behavior indicator representing how often an individual brushes their teeth on a daily or weekly basis to maintain oral hygiene.'}, {'measure': 'Decayed Missing Filled Tooth (DMFT) Index', 'timeFrame': 'Day 1', 'description': 'M refers to the number of teeth lost due to decay.'}, {'measure': 'Decayed Missing Filled Tooth (DMFT) Index', 'timeFrame': 'Day 1', 'description': 'F refers to the number of filled teeth.'}, {'measure': 'Height', 'timeFrame': 'Day 1', 'description': 'Height: a measure of vertical distance, vertical dimension, or vertical position.'}, {'measure': 'Weight', 'timeFrame': 'Day 1', 'description': 'Weight is the gravitational force exerted on an object.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultra-Processed Food', 'tooth decay', 'periodontal disease', 'oral health'], 'conditions': ['Ultra-processed Food']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to examine the potential relationship between ultra-processed food consumption and the presence of dental caries and periodontal disease, and to evaluate the role of the Ultra-Processed Food Index (UPFI) in this association.\n\nThe main question it aims to answer is:\n\nDoes increased consumption of ultra-processed foods raise the risk or severity of dental caries and periodontal disease in individuals?\n\nParticipants will include individuals within a specified age range who voluntarily agree to participate in the study. Oral health status will be assessed through standard clinical parameters, including the presence of caries, plaque index, probing pocket depth, clinical attachment loss, and bleeding on probing. Dietary habits will be evaluated using a validated food frequency questionnaire, and individual UPFI scores will be calculated. The study will aim to observe and analyze the effects of ultra-processed food consumption on oral health outcomes.', 'detailedDescription': 'This observational study will aim to investigate the association between ultra-processed food consumption and oral health outcomes, specifically focusing on dental caries and periodontal disease. Participants will include individuals within a defined age range who consent to take part in the study. Oral health status will be clinically assessed using standard parameters such as the presence of carious lesions, plaque index, probing pocket depth, clinical attachment loss, and bleeding on probing. Dietary intake will be evaluated using a validated food frequency questionnaire, and individual Ultra-Processed Food Index (UPFI) scores will be calculated. The study will analyze whether a higher intake of ultra-processed foods is associated with increased risk or severity of dental caries and periodontal disease. Findings from this study are expected to contribute to a better understanding of the impact of modern dietary patterns on oral health and highlight the importance of nutritional strategies in preventive dentistry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients coming to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine treatment', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals between the ages of 18 and 65,\n* Individuals with at least 20 teeth,\n* Not having received periodontal treatment in the last 6 months,\n* Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks,\n* Not having any autoimmune disease, osteoporosis, or cancer,\n* Not using immunosuppressive drugs, oral contraceptives, or bisphosphonates,\n* Not being pregnant,\n* Not having an active infectious disease (acute hepatitis, tuberculosis, AIDS),\n* Not using chronic medications that affect periodontal tissues (cyclosporine A, Phenytoin),\n* Not having taken antioxidant supplements in the last 6 months.\n\nExclusion Criteria:\n\n* Patients with endocrine or genetic disorders such as hypothyroidism, type 1 diabetes mellitus, or Cushing's syndrome\n* Patients with active infectious disease\n* Patients taking medications that may affect periodontal tissues\n* Patients who have recently taken antibiotics (within 4 months)\n* Patients with alcohol/drug use\n* Patients with psychological disorders\n* Patients with eating disorders, dementia\n* Patients who are pregnant or breastfeeding\n* Patients with any food allergies\n* Patients who do not sign the informed consent form"}, 'identificationModule': {'nctId': 'NCT07427095', 'briefTitle': 'The Relationship Between Ultra-Processed Food Consumption and Oral Health', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University Training and Research Hospital'}, 'officialTitle': 'Investigating the Relationship Between Ultra-Processed Food Consumption and Caries and Periodontal Disease', 'orgStudyIdInfo': {'id': 'UPHOralHealth11/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients', 'description': 'Patients aged between 18-65 will be randomly included.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53200', 'city': 'Rize', 'state': 'Rize Province', 'country': 'Turkey (Türkiye)', 'facility': 'Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}], 'centralContacts': [{'name': 'Oguz KOSE, Professor Dr.', 'role': 'CONTACT', 'email': 'oguz.kose@erdogan.edu.tr', 'phone': '+90 541 348 64 65'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Dilek KARADOĞAN', 'investigatorAffiliation': 'Recep Tayyip Erdogan University Training and Research Hospital'}}}}