Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT06411535
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2024-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Ultra-Processed Food Intake on Gingival Tissue Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2024-05-10', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Full Mouth Bleeding Score (FMBS)', 'timeFrame': 'Full Mouth Bleeding Score (FMBS) collected six sites per tooth, full mouth, will be recorded by a calibrated and blinded examiner at the baseline visit (T0), at two months (T2) and follwing active treatment, at 4 months (T4)', 'description': 'Evaluate the effect of Nutritional Counseling on gingival bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis', 'Ultra-processed Food', 'Prevention']}, 'descriptionModule': {'briefSummary': 'The shift towards consuming more industrialized food products, particularly ultra-processed foods, has been linked to a rise in non-communicable diseases globally. These products are energy-dense, high in unhealthy components, and often lead to overconsumption due to their palatability and convenience. Studies suggest a connection between ultra-processed food consumption and various health issues, including obesity and cardiovascular diseases. The present study is designed as a single-center, double-blind, parallel-arm randomized clinical trial. This study aims to investigate the impact of ultra-processed food consumption on gingival health and to evaluate the potential benefits of dietary counseling and reduced ultra-processed food intake on gingival inflammation over a 4-month period.', 'detailedDescription': 'The impact of shifting of a diet from less industrialized food products toward a more industrialized food products has a positive relationship to the global burden of non- communicable disease. This increase in the consumption of Ultra-Process food was first started in the high-income countries and now in medium-income countries. All together, they are energy dense, high in unhealthy types of fat, refined starches, free sugars and salt, and poor sources of protein, dietary fibre. Ultra-processed products are made to be hyper-palatable and attractive, with long shelf-life and able to be consumed anywhere, any time. Their formulation, presentation and marketing often promote overconsumption. Due to the high levels of additives, sugars and preservatives, they have been associated with various non-communicable diseases, including obesity, cardiovascular diseases and systemic inflammation like periodontitis. In order to investigate a relationship between ultra-process food consumption and gingival health we used a food frequency questionnaire conducted and evaluated in a study in south of Italy with the classification of food according to the NOVA classification.\n\nIn recent years the effect of ultra-processed foods consumption on systemic and oral health has received more attention. Several studies have reported a significant association between caries and ultra-processed food. However, the effect of an highly processed food diet on gingival tissues health has not been fully investigated. Thus, the aim of the present study is to assess the impact of ultra-processed food consumption on gingival inflammation\n\nPrimary Objective:\n\nTo assess the association between ultra-processed food intake and the health of gingival tissues of a University-based cohort of individuals\n\nSecondary Objectives:\n\nTo determine the role of dietary counselling and reduced ultra-processed food consumption on the resolution of gingival inflammation.\n\nTrial design The current protocol is designed as single-centre, double-blind, parallel arm, University-based, superiority, clinical trial with a 4-month follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 40 years of age.\n* Non-smokers (never smokers or former smokers for at least 6 months).\n* Presence of FMBS \\>= 10%\n* No interproximal attachment loss of ≥3 mm in ≥2 non-adjacent teeth\n\nExclusion Criteria:\n\n* Carious lesions and/or inadequate restorations.\n* Subjects currently undergoing orthodontic therapy or wearing occlusal bite guards.\n* Subjects suffering any systemic disease or condition which may affect the response of gingival tissues or the ability to perform adequate plaque control (pregnancy, diabetes, quantitative and/or qualitative polymorphonuclear neutrophils defects, other immune system disorders, etc.)\n* Subjects taking medications that could interfere with the gingival tissues response (i.e. anti-inflammatory agents, diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/immunomodulators)'}, 'identificationModule': {'nctId': 'NCT06411535', 'briefTitle': 'Impact of Ultra-Processed Food Intake on Gingival Tissue Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Siena'}, 'officialTitle': 'Impact of Ultra-Processed Food Intake on Gingival Tissue Health: A Pre-post Clinical Study', 'orgStudyIdInfo': {'id': 'UPF001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients answer the OHIP 14 and the Food Frequency Questionnaires, and are classified according to the NOVA classification. A full-mouth periodontal chart is performed.\n\nAfter 8 weeks, Questionnaires are re-administered. A full-mouth periodontal chart is performed, along with a session of full-mouth ultrasonic debridement.\n\nAfter 16 weeks from baseline, administration of the OHIP 14 and the FFQ is repeated. Clinical variables are re-evaluated.', 'interventionNames': ['Other: Full-mouth ultrasonic debridement']}, {'type': 'EXPERIMENTAL', 'label': 'Nutritional Counseling Group', 'description': 'Patients answer the OHIP 14 and a Food Frequency Questionnaires, and are classified according to the NOVA classification. A full-mouth periodontal chart is perfomed. Patients receive a nutritional counseling on the significance of reducing ultra-processed food intake. Patients receive weekly motivational emails, as part of the dietary counseling.\n\nAfter 8 weeks, Questionnaires are readministered. A full-mouth periodontal chart is performed, along with a session of full-mouth ultrasonic debridement. Nutritional counseling is reinforced. Patients receive weekly motivational emails, as part of the dietary counseling.\n\nAfter 16 weeks from baseline, administration of the OHIP 14 and the FFQ is repeated. Clinical variables are re-evaluated.', 'interventionNames': ['Behavioral: Full-mouth ultrasonic debridement plus Nutritional counseling']}], 'interventions': [{'name': 'Full-mouth ultrasonic debridement plus Nutritional counseling', 'type': 'BEHAVIORAL', 'description': 'After diagnosis of gingivitis, patients will receive a nutritional counseling focused on ultra-processed foods entails educating individuals about the nutritional content and potential health implications of highly processed food products. They will undergo a session of full-mouth ultrasonic debridement and reinforcment of dietary counseling. Between consecutive time points, patients will receive motivational emails.', 'armGroupLabels': ['Nutritional Counseling Group']}, {'name': 'Full-mouth ultrasonic debridement', 'type': 'OTHER', 'description': 'After diagnosis of gingivitis, patients will receive a session of full mouth ultrasonic debridement', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'AOUS', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'overallOfficials': [{'name': 'Nicola Discepoli, DDS MSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medical Biotechnologies, University of Siena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Siena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nicola Discepoli', 'investigatorAffiliation': 'University of Siena'}}}}