Peri-Implant Sulcus Fluid Stress Markers in Health and Disease

NCT07353515 | Completed DMC

• 1 other identifier: TSA-2022-3398
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implantitis; Peri-implant Mucositis; Peri-Implant Health

Keywords

Cortisol; Dehydroepiandrosterone; Depression; Anxiety; Peri-implantitis; Peri-implant sulcular fluid

Outcome Measures

Primary Outcomes (3)

• Peri-implant Sulcular Fluid Cortisol Level

  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

  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

  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 Outcomes (2)

• Anxiety Scores (State-Trait Anxiety Inventory)

  At baseline (single assessment)

• Depression Score (Beck Depression Inventory)

  At baseline

Study Arms (3)

Peri-implant Health

Participants diagnosed with peri-implant health based on clinical and radiographic evaluation.

Diagnostic Test: Psychological Assessment; Diagnostic Test: Peri-implant Sulcular Fluid Biomarker Analysis; Diagnostic Test: Peri-implant Clinical Examination

Peri-implant Mucositis

Participants diagnosed with peri-implant mucositis based on clinical criteria.

Diagnostic Test: Psychological Assessment; Diagnostic Test: Peri-implant Sulcular Fluid Biomarker Analysis; Diagnostic Test: Peri-implant Clinical Examination

Peri-implantitis

Participants diagnosed with peri-implantitis based on clinical and radiographic criteria.

Diagnostic Test: Psychological Assessment; Diagnostic Test: Peri-implant Sulcular Fluid Biomarker Analysis; Diagnostic Test: Peri-implant Clinical Examination; Diagnostic Test: Radiographic Assessment

Interventions

Psychological Assessment DIAGNOSTIC_TEST

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

Peri-implant Health; Peri-implant Mucositis; Peri-implantitis

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.

Peri-implant Health; Peri-implant Mucositis; Peri-implantitis

Radiographic Assessment DIAGNOSTIC_TEST

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

Peri-implantitis

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 Health; Peri-implant Mucositis; Peri-implantitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University, Faculty of Dentistry

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peri-implant sulcus fluid samples collected for biochemical analysis of stress-related and inflammatory markers.

MeSH Terms

Conditions

Peri-Implantitis; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Vesile E Toy, PhD

  Inonu University, Department of Periodontology Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Furkan Kuşoğlu, DDS

  Inonu University, Department of Periodontology Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 20, 2026
• Study Start: February 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: June 15, 2024
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)