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

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

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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