ImplantEFFPCFPDHNCT05921357
Effect of Fermented Products and Probiotics on the Condition of the Implant
An observational study of Implant, run by Tuğba ŞAHİN at 1 site in Turkey (Türkiye).
Trial summary
126 individuals with peri-implant disease and health, aged between 18-70 years, who applied to Bolu University Faculty of Dentistry Periodontology Clinic, participated in the study.The inclusion criteria for patient participation in the study were: age of patients between 18 and 70 years; the presence of at least 20… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Implant
- What is being tested?
- Questionnaire
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jul 2022to 31 Mar 2023
- Phase
- Observational
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Bolu Abant İzzet Baysal University
Who may be able to join
- Systemically healthy individuals
- Individuals between the ages of 18-70
Who cannot join
- No use of antibiotics within one month
- Breastfeeding or being pregnant
- Uncontrolled diabetes, rheumatic fever, history of lung and kidney disorders, and drug use that will affect periodontal tissues
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: Evaluation of Fermented Foods and Probiotic Consumption Frequency in Peri-implant Disease and Health
126 individuals with peri-implant disease and health, aged between 18-70 years, who applied to Bolu University Faculty of Dentistry Periodontology Clinic, participated in the study.The inclusion criteria for patient participation in the study were: age of patients between 18 and 70 years; the presence of at least 20 natural teeth in the oral cavity; systemic health. Peri-implant status was determined by the clinician (T.Ş.) by evaluating dental implants' plaque, gingival index, bleeding on probing, pocket depth measurements, and clinical attachment level. In addition, them systemic illness, pregnancy, breastfeeding status, medication, antibiotic use, and whether they smoked were questioned. Systemically unhealthy patients who did not use antibiotics within a month, were breastfeeding or pregnant, had uncontrolled diabetes, rheumatic fever, a history of lung and kidney disorders, and used drugs that could affect periodontal tissues were not included in the study. After examination, the patients were divided into three groups according to their disease: Peri-implantitis (42 patients), peri-implantitis (42 patients), and peri-implant health (42 patients). Demographic characteristics (age, weight, gender, height, education, and employment status) of the participants were collected with a questionnaire. With this survey, fermented foods and probiotic products such as bacon, soy sauce, pickles, sourdough bread, whole grain, rye, wholemeal bread, ayran, kefir, turnip, vinegar (homemade), pomegranate syrup (homemade), probiotic beverage, the frequency and amount of consumption of cheese, dark chocolate, tablets, capsules, chassis, butter and other (Kimchi, sauerkrauth, miso soup, fermented herring, kombucha, etc.) were determined. It was requested to determine the relationship between the health and disease of the implant and the frequency of consumption of fermented and probiotic products and foods in individuals with implants.
- Conditions
- Implant
- Being tested
- Questionnaire
- Keywords
- Fermented foods, probiotics, peri-implant health, peri-implant mucositis, peri-implantitis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire and examine
| Study group | Role | What they receive |
|---|---|---|
| Peri-implantitis | Implants with a pocket depth of more than 5 mm and bleeding on probing Receives: Other: Questionnaire | |
| Peri-implant mucositis | Implants with no bone loss but bleeding on probing Receives: Other: Questionnaire | |
| Peri-implant health | Implants with no bone loss but no bleeding on probing Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption frequency
the number of times a product is consumed in a given time period.
Measured: Baseline
Consumption amount
The average quantity of an item consumed or expended during a given time interval, expressed in quantities by the most appropriate unit of measurement per applicable stated basis.
Measured: Baseline
Daily intake
The amount of a substance that people can consume on a daily basis
Measured: Baseline
Bleeding on probing
Bleeding, leading sign of inflammation inside the connective tissue, is a critical factor for pocket depth measurements, and with other variable factors prevents making reproducible measurements.
Measured: Baseline
Periodontal pocket depth
a pathologically deepened gingival sulcus around a tooth at the gingival margin.
Measured: Baseline
Secondary outcomes (3)
Plaque index
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth
Measured: Baseline
Gingival index
This measurement is based on the presence or absence of bleeding on gentle probing.
Measured: Baseline
Clinical attachment level
CAL is calculated by subtracting the gingival margin level from the probing depth.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start4 Jul 2022
- Primary completion4 Jul 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImplantStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 126 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
- NCT05921357
- Sponsor's protocol ID
- 2022/196
- Acronym
- EFFPCFPDH
- Status last verified
- Feb 2025
- First submitted
- 18 Jun 2023
- 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
- Evaluation of Fermented Foods and Probiotic Consumption Frequency in Peri-implant Disease and Health
- ClinicalTrials.gov ID
- NCT05921357
- Acronym / sponsor ID
- EFFPCFPDH / 2022/196
- Conditions
- Implant
- Keywords
- Fermented foods, probiotics, peri-implant health, peri-implant mucositis, peri-implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Tuğba ŞAHİNUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 27 Jun 2023 (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.
126 individuals with peri-implant disease and health, aged between 18-70 years, who applied to Bolu University Faculty of Dentistry Periodontology Clinic, participated in the study.The inclusion criteria for patient participation in the study were: age of patients between 18 and 70 years; the presence of at least 20 natural teeth in the oral cavity; systemic health. Peri-implant status was determined by the clinician (T.Ş.) by evaluating dental implants' plaque, gingival index, bleeding on probing, pocket depth measurements, and clinical attachment level. In addition, them systemic illness, pregnancy, breastfeeding status, medication, antibiotic use, and whether they smoked were questioned. Systemically unhealthy patients who did not use antibiotics within a month, were breastfeeding or pregnant, had uncontrolled diabetes, rheumatic fever, a history of lung and kidney disorders, and used drugs that could affect periodontal tissues were not included in the study. After examination, the patients were divided into three groups according to their disease: Peri-implantitis (42 patients), peri-implantitis (42 patients), and peri-implant health (42 patients). Demographic characteristics (age, weight, gender, height, education, and employment status) of the participants were collected with a questionnaire. With this survey, fermented foods and probiotic products such as bacon, soy sauce, pickles, sourdough bread, whole grain, rye, wholemeal bread, ayran, kefir, turnip, vinegar (homemade), pomegranate syrup (homemade), probiotic beverage, the frequency and amount of consumption of cheese, dark chocolate, tablets, capsules, chassis, butter and other (Kimchi, sauerkrauth, miso soup, fermented herring, kombucha, etc.) were determined. It was requested to determine the relationship between the health and disease of the implant and the frequency of consumption of fermented and probiotic products and foods in individuals with implants.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peri-implantitis | – | Other: QuestionnaireImplants with a pocket depth of more than 5 mm and bleeding on probing |
| Peri-implant mucositis | – | Other: QuestionnaireImplants with no bone loss but bleeding on probing |
| Peri-implant health | – | Other: QuestionnaireImplants with no bone loss but no bleeding on probing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bolu Abant İzzet Baysal University
Key inclusion criteria (2 listed)
- Systemically healthy individuals
- Individuals between the ages of 18-70
Key exclusion criteria (3 listed)
- No use of antibiotics within one month
- Breastfeeding or being pregnant
- Uncontrolled diabetes, rheumatic fever, history of lung and kidney disorders, and drug use that will affect periodontal tissues
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 |
|---|---|---|
| QuestionnaireQuestionnaire and examine | Other | Peri-implant health, Peri-implant mucositis, Peri-implantitis |
Primary outcome
Consumption frequency
Time frame: Baseline
the number of times a product is consumed in a given time period.
Consumption amount
Time frame: Baseline
The average quantity of an item consumed or expended during a given time interval, expressed in quantities by the most appropriate unit of measurement per applicable stated basis.
Daily intake
Time frame: Baseline
The amount of a substance that people can consume on a daily basis
Bleeding on probing
Time frame: Baseline
Bleeding, leading sign of inflammation inside the connective tissue, is a critical factor for pocket depth measurements, and with other variable factors prevents making reproducible measurements.
Periodontal pocket depth
Time frame: Baseline
a pathologically deepened gingival sulcus around a tooth at the gingival margin.
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?
An observational study of Implant, 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 2 inclusion and 3 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?
Consumption frequency (time frame: Baseline). The study lists 5 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.