- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07427095
The Relationship Between Ultra-Processed Food Consumption and Oral Health
Investigating the Relationship Between Ultra-Processed Food Consumption and Caries and Periodontal Disease
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.
The main question it aims to answer is:
Does increased consumption of ultra-processed foods raise the risk or severity of dental caries and periodontal disease in individuals?
Participants 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Oguz KOSE, Professor Dr.
- Phone Number: +90 541 348 64 65
- Email: oguz.kose@erdogan.edu.tr
Study Locations
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Rize Province
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Rize, Rize Province, Turkey (Türkiye), 53200
- Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals between the ages of 18 and 65,
- Individuals with at least 20 teeth,
- Not having received periodontal treatment in the last 6 months,
- Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks,
- Not having any autoimmune disease, osteoporosis, or cancer,
- Not using immunosuppressive drugs, oral contraceptives, or bisphosphonates,
- Not being pregnant,
- Not having an active infectious disease (acute hepatitis, tuberculosis, AIDS),
- Not using chronic medications that affect periodontal tissues (cyclosporine A, Phenytoin),
- Not having taken antioxidant supplements in the last 6 months.
Exclusion Criteria:
- Patients with endocrine or genetic disorders such as hypothyroidism, type 1 diabetes mellitus, or Cushing's syndrome
- Patients with active infectious disease
- Patients taking medications that may affect periodontal tissues
- Patients who have recently taken antibiotics (within 4 months)
- Patients with alcohol/drug use
- Patients with psychological disorders
- Patients with eating disorders, dementia
- Patients who are pregnant or breastfeeding
- Patients with any food allergies
- Patients who do not sign the informed consent form
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Adult patients
Patients aged between 18-65 will be randomly included.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ultra-Processed Food Index (UPFI)
Time Frame: Day 1
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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.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height
Time Frame: Day 1
|
Height: a measure of vertical distance, vertical dimension, or vertical position.
|
Day 1
|
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Weight
Time Frame: Day 1
|
Weight is the gravitational force exerted on an object.
|
Day 1
|
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Decayed Missing Filled Tooth (DMFT) Index
Time Frame: Day 1
|
D stands for decayed tooth
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Day 1
|
|
Community Periodontal Index (CPI) Score
Time Frame: Day 1
|
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: 0 - Healthy;
|
Day 1
|
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Age
Time Frame: Day 1
|
Age is a demographic variable representing the time elapsed since birth and is a fundamental determinant in the assessment of health outcomes.
|
Day 1
|
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Waist Circumference
Time Frame: Day 1
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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.
|
Day 1
|
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Gender
Time Frame: Day 1
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Gender is a demographic variable referring to the biological classification of an individual as female or male.
|
Day 1
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Weight satisfaction
Time Frame: Day 1
|
Weight satisfaction is a psychosocial indicator reflecting an individual's subjective level of satisfaction with their current body weight.
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Day 1
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Educational level
Time Frame: Day 1
|
Educational level is a sociodemographic indicator representing the highest level of formal education completed by an individual.
|
Day 1
|
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Income level
Time Frame: Day 1
|
Income level is a socioeconomic indicator reflecting the economic status of an individual or household and influencing health behaviors and access to healthcare
|
Day 1
|
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Smoking status
Time Frame: Day 1
|
Smoking status is a behavioral variable indicating the use of tobacco products and is a risk factor for numerous systemic and oral diseases.
|
Day 1
|
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Toothbrushing frequency
Time Frame: Day 1
|
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.
|
Day 1
|
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Decayed Missing Filled Tooth (DMFT) Index
Time Frame: Day 1
|
M refers to the number of teeth lost due to decay.
|
Day 1
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Decayed Missing Filled Tooth (DMFT) Index
Time Frame: Day 1
|
F refers to the number of filled teeth.
|
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPHOralHealth11/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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