- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05921357
Effect of Fermented Products and Probiotics on the Condition of the Implant (EFFPCFPDH)
June 18, 2023 updated by: Tuğba ŞAHİN
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
126
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bolu, Turkey
- Bolu Abant İzzet Baysal University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Bolu Abant İzzet Baysal University
Description
Inclusion Criteria:
- Systemically healthy individuals
- Individuals between the ages of 18-70
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Peri-implantitis
Implants with a pocket depth of more than 5 mm and bleeding on probing
|
Questionnaire and examine
|
Peri-implant mucositis
Implants with no bone loss but bleeding on probing
|
Questionnaire and examine
|
Peri-implant health
Implants with no bone loss but no bleeding on probing
|
Questionnaire and examine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consumption frequency
Time Frame: Baseline
|
the number of times a product is consumed in a given time period.
|
Baseline
|
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.
|
Baseline
|
Daily intake
Time Frame: Baseline
|
The amount of a substance that people can consume on a daily basis
|
Baseline
|
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.
|
Baseline
|
Periodontal pocket depth
Time Frame: Baseline
|
a pathologically deepened gingival sulcus around a tooth at the gingival margin.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plaque index
Time Frame: Baseline
|
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth
|
Baseline
|
Gingival index
Time Frame: Baseline
|
This measurement is based on the presence or absence of bleeding on gentle probing.
|
Baseline
|
Clinical attachment level
Time Frame: Baseline
|
CAL is calculated by subtracting the gingival margin level from the probing depth.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 4, 2022
Primary Completion (Actual)
July 4, 2022
Study Completion (Actual)
March 31, 2023
Study Registration Dates
First Submitted
June 18, 2023
First Submitted That Met QC Criteria
June 18, 2023
First Posted (Actual)
June 27, 2023
Study Record Updates
Last Update Posted (Actual)
June 27, 2023
Last Update Submitted That Met QC Criteria
June 18, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/196
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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