NCT05921357

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

Same day

First QC Date

June 18, 2023

Last Update Submit

February 2, 2025

Conditions

Keywords

Fermented foodsprobioticsperi-implant healthperi-implant mucositisperi-implantitis

Outcome Measures

Primary Outcomes (5)

  • Consumption frequency

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

    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.

    Baseline

  • Daily intake

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

    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.

    Baseline

  • Periodontal pocket depth

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

    Baseline

Secondary Outcomes (3)

  • Plaque index

    Baseline

  • Gingival index

    Baseline

  • Clinical attachment level

    Baseline

Study Arms (3)

Peri-implantitis

Implants with a pocket depth of more than 5 mm and bleeding on probing

Other: Questionnaire

Peri-implant mucositis

Implants with no bone loss but bleeding on probing

Other: Questionnaire

Peri-implant health

Implants with no bone loss but no bleeding on probing

Other: Questionnaire

Interventions

Questionnaire and examine

Peri-implant healthPeri-implant mucositisPeri-implantitis

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Bolu Abant İzzet Baysal University

You may qualify if:

  • Systemically healthy individuals
  • Individuals between the ages of 18-70

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, Turkey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 18, 2023

First Posted

June 27, 2023

Study Start

July 4, 2022

Primary Completion

July 4, 2022

Study Completion

March 31, 2023

Last Updated

February 4, 2025

Record last verified: 2025-02

Locations