- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07353515
Peri-Implant Sulcus Fluid Stress Markers in Health and Disease
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
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Battalgazi
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Malatya, Battalgazi, Turkey (Türkiye), 44280
- Inonu University, Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
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At baseline
|
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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)
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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.
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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.
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At baseline (single assessment)
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Depression Score (Beck Depression Inventory)
Time Frame: At baseline
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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.
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At baseline
|
Collaborators and Investigators
Sponsor
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TSA-2022-3398
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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