Periodontal DiseasesNCT05602545
Periodontal Status in Fermented Food and Food Consumption
A study testing food consumption in periodontal health and disease in people with Periodontal Diseases, run by Tuğba ŞAHİN at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- food consumption in periodontal health and disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 25 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with three teeth other than 20-year-old teeth in each jaw
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University
Bolu, Turkey
About this study
Official title: 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.
- Conditions
- Periodontal Diseases
- Being tested
- food consumption in periodontal health and disease
- Keywords
- fermented foods, periodontal health, periodontal disease
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food consumption in periodontal health and diseaseOther
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 group | Role | What they receive |
|---|---|---|
| Peri-implantitis | Experimental | patients with peri-implantitis Receives: Other: food consumption in periodontal health and disease |
| Peri-implant mucositis | Experimental | patients with peri-implant mucositis Receives: Other: food consumption in periodontal health and disease |
| Peri-implant health | Other | patients with peri-implant health Receives: Other: food consumption in periodontal health and disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
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.
Measured: baseline
Frequency of consumption of fermented foods
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.
Measured: baseline
food consumption record
One or three days of consumption is recorded
Measured: 1 or 3 days
Secondary outcomes (3)
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. The situation worsens as the score increases.
Measured: baseline
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. The situation worsens as the score increases.
Measured: baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Jul 2021
- Primary completion27 Sep 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Crossover
- Model description
- observational study
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuğba ŞAHİN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuğba ŞAHİN, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602545
- Sponsor's protocol ID
- BAIBU-DH-TS-01
- Status last verified
- Feb 2025
- First submitted
- 29 Sep 2022
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Consumption of Some Fermented Foods and Nutrient Intakes in Individuals with Periodontal Disease and Periodontal Health
- ClinicalTrials.gov ID
- NCT05602545
- Acronym / sponsor ID
- BAIBU-DH-TS-01
- Conditions
- Periodontal Diseases
- Keywords
- fermented foods, periodontal health, periodontal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Tuğba ŞAHİNUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- observational study
| Arm | Type | Receives |
|---|---|---|
| Peri-implantitis | Experimental | Other: food consumption in periodontal health and diseasepatients with peri-implantitis |
| Peri-implant mucositis | Experimental | Other: food consumption in periodontal health and diseasepatients with peri-implant mucositis |
| Peri-implant health | Other | Other: food consumption in periodontal health and diseasepatients with peri-implant health |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with three teeth other than 20-year-old teeth in each jaw
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food consumption in periodontal health and diseaseTo 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, Peri-implant mucositis, Peri-implantitis |
Primary outcome
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.
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.
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.
food consumption record
Time frame: 1 or 3 days
One or three days of consumption is recorded
3 secondary outcomes
plaque index
Time frame: baseline
gingival index
Time frame: baseline
clinical attachment level
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food consumption in periodontal health and disease in people with Periodontal Diseases, run by Tuğba ŞAHİN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding on probing (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.