Peri-Implant Sulcus Fluid Stress Markers in Health and Disease

January 18, 2026 updated by: Vesile Elif Toy, Inonu University

Evaluation of Peri-implant Sulcus Fluid Stress Marker Levels in Peri-implant 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.

Study Overview

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 Type

Observational

Enrollment (Actual)

62

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

    • Battalgazi
      • Malatya, Battalgazi, Turkey (Türkiye), 44280
        • Inonu University, Faculty of Dentistry

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

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of adult individuals aged 18-65 years with at least one functional dental implant. Participants were selected from patients attending the Department of Periodontology, Faculty of Dentistry, Inonu University, and were classified into peri-implant health, peri-implant mucositis, or peri-implantitis groups based on clinical and radiographic criteria.

Description

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.

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-implant Health
Participants diagnosed with peri-implant health based on clinical and radiographic evaluation.
Psychological status was evaluated using the Beck Depression Inventory (BDI) and the State-Trait Anxiety Inventory (STAI).
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).
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.
Peri-implant Mucositis
Participants diagnosed with peri-implant mucositis based on clinical criteria.
Psychological status was evaluated using the Beck Depression Inventory (BDI) and the State-Trait Anxiety Inventory (STAI).
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).
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.
Peri-implantitis
Participants diagnosed with peri-implantitis based on clinical and radiographic criteria.
Psychological status was evaluated using the Beck Depression Inventory (BDI) and the State-Trait Anxiety Inventory (STAI).
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).
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.
Marginal bone levels around dental implants were assessed using standardized periapical radiographs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline
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.
At baseline (single assessment)
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.
At baseline (single assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline (single assessment)
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.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vesile E Toy, PhD, Inonu University, Department of Periodontology Faculty of Dentistry
  • Study Chair: Furkan Kuşoğlu, DDS, Inonu University, Department of Periodontology Faculty of Dentistry

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)

February 15, 2023

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data will be shared upon request by primary investigator Dr Vesile Elif toy elif.toy@inonu.edu.tr

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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