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Completed

NCT Number: NCT05921357

Effect of Fermented Products and Probiotics on the Condition of the Implant

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Bolu Abant İzzet Baysal University

Bolu, Turkey, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Questionnaire and examine

Primary outcomes

  1. Consumption frequency

    Time frame: Baseline

    the number of times a product is consumed in a given time period.

  2. 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.

  3. Daily intake

    Time frame: Baseline

    The amount of a substance that people can consume on a daily basis

  4. 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.

  5. Periodontal pocket depth

    Time frame: Baseline

    a pathologically deepened gingival sulcus around a tooth at the gingival margin.

Secondary outcomes

  1. Plaque index

    Time frame: Baseline

    The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth

  2. Gingival index

    Time frame: Baseline

    This measurement is based on the presence or absence of bleeding on gentle probing.

  3. Clinical attachment level

    Time frame: Baseline

    CAL is calculated by subtracting the gingival margin level from the probing depth.

Sponsors and collaborators

Lead sponsor

Tuğba ŞAHİN

Other

Registry information

Official study title

Evaluation of Fermented Foods and Probiotic Consumption Frequency in Peri-implant Disease and Health

Acronym: EFFPCFPDH

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 27, 2023
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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