- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05602545
Periodontal Status in Fermented Food and Food Consumption
Comparison of Consumption of Some Fermented Foods and Nutrient Intakes in Individuals with Periodontal Disease and Periodontal Health
Lack of certain nutrients and foods may negatively affect oral health. Therefore, nutrition plays an important role in maintaining oral health. This study aimed to evaluate and compare the nutrient intakes, consumption of food groups and some fermented foods of individuals with periodontal disease and health.
Ninety-three patients who applied to Periodontology Clinic were divided into three groups: periodontal health, gingivitis and periodontitis. In addition, plaque, gingival indices, bleeding on probing, periodontal pocket depth, and clinical attachment level were evaluated. To determine individuals' daily energy and nutrient intakes and the consumption amounts of food groups, food consumption records were kept by the nutritionist for three consecutive days, with one of them was weekend, using the 24-hour recall method. Data on individuals' frequency and amount of consumption of some fermented products were recorded, considering the foods available in our culture and the market.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bolu, Turkey
- Bolu abant Izzet Baysal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with three teeth other than 20-year-old teeth in each jaw
Exclusion Criteria:
- Pregnancy and lactation,
- Patients with an acute oral lesion or necrotizing ulcerative periodontitis, -
- Patients with history of diabetes, rheumatic fever, lung and kidney disorders, and use of drugs that affect periodontal tissues (regular use of antibiotics, anti-inflammatory and mouthwashes),
- Patients who smoke, or patients who did not quit until last year were not included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peri-implantitis
patients with peri-implantitis
|
To determine individuals' daily energy and nutrient intakes and the consumption amounts of food groups, food consumption records were kept by the nutritionist for three consecutive days, with one of them was weekend, using the 24-hour recall method.
Data on individuals' frequency and amount of consumption of some fermented products were recorded, considering the foods available in our culture and the market.
|
|
Experimental: Peri-implant mucositis
patients with peri-implant mucositis
|
To determine individuals' daily energy and nutrient intakes and the consumption amounts of food groups, food consumption records were kept by the nutritionist for three consecutive days, with one of them was weekend, using the 24-hour recall method.
Data on individuals' frequency and amount of consumption of some fermented products were recorded, considering the foods available in our culture and the market.
|
|
Other: Peri-implant health
patients with peri-implant health
|
To determine individuals' daily energy and nutrient intakes and the consumption amounts of food groups, food consumption records were kept by the nutritionist for three consecutive days, with one of them was weekend, using the 24-hour recall method.
Data on individuals' frequency and amount of consumption of some fermented products were recorded, considering the foods available in our culture and the market.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bleeding on probing
Time Frame: baseline
|
To test for bleeding after probing, the probe is carefully introduced to the bottom of the pocket and gently moved laterally along the pocket wall.
+ is maximum and - is minimum.
|
baseline
|
|
periodontal pocket depth
Time Frame: baseline
|
physical methods to measure the distance from the bottom of a pocket to a reference line, usually the gingival margin or the cemento-enamel junction.
|
baseline
|
|
food consumption record
Time Frame: 1 or 3 days
|
One or three days of consumption is recorded
|
1 or 3 days
|
|
Frequency of consumption of fermented foods
Time Frame: baseline
|
the frequency of fermented foods is measured.
The foods questioned were evaluated using a 7-point Likert-type frequency form (every day, 3-4 per week, 1-2 per week, 2 per month, 1 per month, never).
In addition, the amounts of foods consumed each time were recorded, and the daily consumption amounts were obtained by dividing them by the frequency of consumption.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical attachment level
Time Frame: baseline
|
The clinical attachment level (CAL) and radiographically assessed bone levels are used to assess the loss of periodontal tissue support in periodontitis, a chronic, multifactorial inflammatory disease of the periodontium.
|
baseline
|
|
plaque index
Time Frame: baseline
|
an index for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin.
0 is minimum and 3 is maximum.
The situation worsens as the score increases.
|
baseline
|
|
gingival index
Time Frame: baseline
|
The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
0 is minimum and 3 is maximum.
The situation worsens as the score increases.
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- BAIBU-DH-TS-01
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
product manufactured in and exported from the U.S.
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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