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Clinical Trials/NCT07353515
NCT07353515
Completed
Not Applicable

Evaluation of Peri-implant Sulcus Fluid Stress Marker Levels in Peri-implant Health and Disease

Inonu University0 sites62 target enrollmentStarted: February 15, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
62

Overview

Brief Summary

This study examines the association between psychosocial stress and peri-implant diseases. Peri-implant diseases are inflammatory conditions affecting the tissues around dental implants and may contribute to implant failure. Stress-related hormones, including cortisol and dehydroepiandrosterone (DHEA), may influence inflammatory responses in peri-implant tissues.

In this study, peri-implant sulcular fluid samples are collected from patients with peri-implant health, peri-implant mucositis, and peri-implantitis. Levels of cortisol, DHEA, and interleukin-6 (IL-6) are analyzed. Anxiety and depression levels are assessed using standardized questionnaires, and clinical peri-implant parameters are recorded.

The purpose of this study is to evaluate the relationship between stress-related biomarkers, psychological status, and peri-implant health and disease.

Detailed Description

Peri-implant diseases are inflammatory conditions affecting the soft and hard tissues surrounding dental implants and represent a major cause of implant failure. Psychosocial stress is known to influence immune function through activation of the hypothalamic-pituitary-adrenal (HPA) axis, resulting in altered secretion of stress-related hormones such as cortisol and dehydroepiandrosterone (DHEA). These hormonal changes may modulate inflammatory processes in peri-implant tissues.

This cross-sectional clinical study included 62 patients with dental implants, who were divided into three groups based on clinical and radiographic criteria: peri-implant health (PH, n=18), peri-implant mucositis (PM, n=22), and peri-implantitis (PI, n=22). Depression and anxiety levels were assessed using the Beck Depression Inventory (BDI) and the State-Trait Anxiety Inventory (STAI).

Clinical peri-implant parameters, including plaque index, gingival index, bleeding on probing, probing depth, clinical attachment level, and keratinized tissue width, were recorded. Marginal bone loss was evaluated using standardized periapical radiographs. Peri-implant sulcular fluid samples were collected and analyzed for cortisol, DHEA, and interleukin-6 (IL-6) levels using enzyme-linked immunosorbent assay (ELISA). Biomarker results were expressed as both concentration and total amount.

The study evaluates the associations between psychosocial stress markers, inflammatory biomarkers, and clinical peri-implant parameters to better understand the psychoneuroimmunological mechanisms involved in peri-implant diseases.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Being volunteer to participate in the study
  • Adults aged 18 to 65 years.
  • Systemically healthy individuals.
  • No periodontal treatment within the past 6 months.
  • No self-reported psychiatric disorders.
  • No use of antibiotics within the past 6 months.
  • No use of steroid, immunosuppressive, or psychiatric medications.
  • No clinically evident oral infection.
  • Not pregnant and not breastfeeding.
  • Not smoking

Exclusion Criteria

  • Age younger than 18 years or older than 65 years.
  • History of periodontal treatment within the past 6 months.
  • Use of antibiotics within the past 6 months.
  • Inadequate or contaminated peri-implant sulcular fluid samples.
  • Pregnancy or breastfeeding.
  • Long-term corticosteroid usage.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vesile Elif Toy

Assistant Professor

Inonu University

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