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Periodontal Status in Fermented Food and Food Consumption

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
food consumption in periodontal health and disease
Sponsored by
Tuğba ŞAHİN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontal Diseases focused on measuring fermented foods, periodontal health, periodontal disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with three teeth other than 20-year-old teeth in each jaw Exclusion Criteria: Pregnancy, lactation, patients with an acute oral lesion or necrotizing ulcerative periodontitis, 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.

Sites / Locations

  • Bolu Abant İzzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Test-1

Test-2

control

Arm Description

patients with peri-implantitis

patients with peri-implant mucositis

patients with peri-implant health

Outcomes

Primary Outcome Measures

bleeding on probing
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.
periodontal pocket depth
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.
Frequency of consumption of fermented foods
the frequency of fermented foods is measured
food consumption record
One or three days of consumption is recorded

Secondary Outcome Measures

plaque index
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.
gingival index
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.
clinical attachment level
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.

Full Information

First Posted
September 29, 2022
Last Updated
October 26, 2022
Sponsor
Tuğba ŞAHİN
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1. Study Identification

Unique Protocol Identification Number
NCT05602545
Brief Title
Periodontal Status in Fermented Food and Food Consumption
Official Title
Comparison of Consumption of Some Fermented Foods and Nutrient Intakes in Individuals With Periodontal Disease and Periodontal Health
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
December 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tuğba ŞAHİN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
fermented foods, periodontal health, periodontal disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel controlled trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test-1
Arm Type
Experimental
Arm Description
patients with peri-implantitis
Arm Title
Test-2
Arm Type
Experimental
Arm Description
patients with peri-implant mucositis
Arm Title
control
Arm Type
Other
Arm Description
patients with peri-implant health
Intervention Type
Other
Intervention Name(s)
food consumption in periodontal health and disease
Intervention Description
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.
Primary Outcome Measure Information:
Title
bleeding on probing
Description
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.
Time Frame
baseline
Title
periodontal pocket depth
Description
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.
Time Frame
baseline
Title
Frequency of consumption of fermented foods
Description
the frequency of fermented foods is measured
Time Frame
baseline
Title
food consumption record
Description
One or three days of consumption is recorded
Time Frame
1 or 3 days
Secondary Outcome Measure Information:
Title
plaque index
Description
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.
Time Frame
baseline
Title
gingival index
Description
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.
Time Frame
baseline
Title
clinical attachment level
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with three teeth other than 20-year-old teeth in each jaw Exclusion Criteria: Pregnancy, lactation, patients with an acute oral lesion or necrotizing ulcerative periodontitis, 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.
Facility Information:
Facility Name
Bolu Abant İzzet Baysal University
City
Bolu
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Periodontal Status in Fermented Food and Food Consumption

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