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Completed

NCT Number: NCT07353515

Peri-Implant Sulcus Fluid Stress Markers in Health and Disease

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inonu University, Faculty of Dentistry

Malatya, Battalgazi, 44280, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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
  • Maintaining oral hygiene

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.

Treatment and study plan

Psychological Assessment

Diagnostic Test

Psychological status was evaluated using the Beck Depression Inventory (BDI) and the State-Trait Anxiety Inventory (STAI).

Peri-implant Sulcular Fluid Biomarker Analysis

Diagnostic Test

Peri-implant sulcular fluid samples were collected and analyzed for cortisol, dehydroepiandrosterone (DHEA), and interleukin-6 (IL-6) levels using enzyme-linked immunosorbent assay (ELISA).

Peri-implant Clinical Examination

Diagnostic Test

Clinical peri-implant parameters including plaque index, gingival index, bleeding on probing, probing depth, clinical attachment level, and keratinized tissue width were recorded using a periodontal probe.

Radiographic Assessment

Diagnostic Test

Marginal bone levels around dental implants were assessed using standardized periapical radiographs.

Primary outcomes

  1. Peri-implant Sulcular Fluid Cortisol Level

    Time frame: At baseline

    Peri-implant sulcular fluid cortisol levels were measured using enzyme-linked immunosorbent assay (ELISA). Biomarker amounts were initially calculated as ng per 30 seconds of collection time and subsequently expressed as concentrations (ng/mL) for analysis and comparison among peri-implant health, peri-implant mucositis, and peri-implantitis groups.

  2. Peri-implant Sulcular Fluid Interleukin-6 Level

    Time frame: At baseline (single assessment)

    Interleukin-6 levels in peri-implant sulcular fluid were measured using enzyme-linked immunosorbent assay (ELISA). Biomarker amounts were calculated as pg per 30 seconds of collection time and subsequently expressed as concentrations (ng/mL) for analysis and comparison among peri-implant health, peri-implant mucositis, and peri-implantitis groups.

  3. Peri-implant Sulcular Fluid DHEA Level

    Time frame: At baseline (single assessment)

    Peri-implant sulcular fluid dehydroepiandrosterone (DHEA) levels were measured using enzyme-linked immunosorbent assay (ELISA). Biomarker amounts were calculated as ng per 30 seconds of collection time and subsequently expressed as concentrations (ng/mL) for analysis and comparison among peri-implant health, peri-implant mucositis, and peri-implantitis groups.

Secondary outcomes

  1. Anxiety Scores (State-Trait Anxiety Inventory)

    Time frame: At baseline (single assessment)

    Anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI), which consists of two subscales: the State Anxiety scale (STAI-I) and the Trait Anxiety scale (STAI-II). Each subscale includes 20 items, with total scores ranging from 20 to 80. Higher scores indicate greater levels of anxiety.

  2. Depression Score (Beck Depression Inventory)

    Time frame: At baseline

    Depression levels were assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

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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