Peri-implantitisNCT07353515
Peri-Implant Sulcus Fluid Stress Markers in Health and Disease
An observational study of Peri-implantitis and Peri-implant Mucositis, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis, Peri-implant Mucositis, Peri-Implant Health
- What is being tested?
- Psychological Assessment, Peri-implant Sulcular Fluid Biomarker Analysis and Peri-implant Clinical Examination
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 11Show fewer
- No use of steroid, immunosuppressive, or psychiatric medications.
- No clinically evident oral infection.
- Not pregnant and not breastfeeding.
- Not smoking
- Maintaining oral hygiene
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University, Faculty of Dentistry
Malatya, Battalgazi, 44280
About this study
Official title: 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.
Read the 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.
- Being tested
- Psychological Assessment, Peri-implant Sulcular Fluid Biomarker Analysis, Peri-implant Clinical Examination, Radiographic Assessment
- Keywords
- Cortisol, Dehydroepiandrosterone, Depression, Anxiety, Peri-implantitis, Peri-implant sulcular fluid
- Medical subject headings
- Peri-Implantitis, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological AssessmentDiagnostic test
Psychological status was evaluated using the Beck Depression Inventory (BDI) and the State-Trait Anxiety Inventory (STAI).
Peri-implant Sulcular Fluid Biomarker AnalysisDiagnostic 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 ExaminationDiagnostic 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 AssessmentDiagnostic test
Marginal bone levels around dental implants were assessed using standardized periapical radiographs.
| Study group | Role | What they receive |
|---|---|---|
| Peri-implant Health | Participants diagnosed with peri-implant health based on clinical and radiographic evaluation. Receives: 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. Receives: 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. Receives: Diagnostic Test: Psychological Assessment; Diagnostic Test: Peri-implant Sulcular Fluid Biomarker Analysis; Diagnostic Test: Peri-implant Clinical Examination; Diagnostic Test: Radiographic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline (single assessment)
Secondary outcomes (2)
Anxiety Scores (State-Trait Anxiety Inventory)
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.
Measured: At baseline (single assessment)
Depression Score (Beck Depression Inventory)
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Feb 2023
- Primary completion15 Dec 2023
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesile Elif Toy, Inonu University
- Investigators
- Vesile E Toy, PhD, Principal investigator, Inonu University, Department of Periodontology Faculty of DentistryFurkan Kuşoğlu, DDS, Study chair, Inonu University, Department of Periodontology Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353515
- Sponsor's protocol ID
- TSA-2022-3398
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be shared upon request by primary investigator Dr Vesile Elif toy elif.toy@inonu.edu.tr
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peri-implant Sulcus Fluid Stress Marker Levels in Peri-implant Health and Disease
- ClinicalTrials.gov ID
- NCT07353515
- Acronym / sponsor ID
- TSA-2022-3398
- Keywords
- Cortisol, Dehydroepiandrosterone, Depression, Anxiety, Peri-implantitis, Peri-implant sulcular fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peri-implant Health | – | Diagnostic Test: Psychological Assessment, Diagnostic Test: Peri-implant Sulcular Fluid Biomarker Analysis, Diagnostic Test: Peri-implant Clinical ExaminationParticipants diagnosed with peri-implant health based on clinical and radiographic evaluation. |
| Peri-implant Mucositis | – | Diagnostic Test: Psychological Assessment, Diagnostic Test: Peri-implant Sulcular Fluid Biomarker Analysis, Diagnostic Test: Peri-implant Clinical ExaminationParticipants diagnosed with peri-implant mucositis based on clinical criteria. |
| Peri-implantitis | – | Diagnostic Test: Psychological Assessment, Diagnostic Test: Peri-implant Sulcular Fluid Biomarker Analysis, Diagnostic Test: Peri-implant Clinical Examination, Diagnostic Test: Radiographic AssessmentParticipants diagnosed with peri-implantitis based on clinical and radiographic criteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological AssessmentPsychological status was evaluated using the Beck Depression Inventory (BDI) and the State-Trait Anxiety Inventory (STAI). | Diagnostic test | Peri-implant Health, Peri-implant Mucositis, Peri-implantitis |
| Peri-implant Sulcular Fluid Biomarker AnalysisPeri-implant sulcular fluid samples were collected and analyzed for cortisol, dehydroepiandrosterone (DHEA), and interleukin-6 (IL-6) levels using enzyme-linked immunosorbent assay (ELISA). | Diagnostic test | Peri-implant Health, Peri-implant Mucositis, Peri-implantitis |
| Peri-implant Clinical ExaminationClinical 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. | Diagnostic test | Peri-implant Health, Peri-implant Mucositis, Peri-implantitis |
| Radiographic AssessmentMarginal bone levels around dental implants were assessed using standardized periapical radiographs. | Diagnostic test | Peri-implantitis |
Primary outcome
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.
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.
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.
2 secondary outcomes
Anxiety Scores (State-Trait Anxiety Inventory)
Time frame: At baseline (single assessment)
Depression Score (Beck Depression Inventory)
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Yes. Study data will be shared upon request by primary investigator Dr Vesile Elif toy elif.toy@inonu.edu.tr
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vesile E Toy, PhD principal investigator
Inonu University, Department of Periodontology Faculty of Dentistry
Furkan Kuşoğlu, DDS study chair
Inonu University, Department of Periodontology Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-implantitis and Peri-implant Mucositis, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant Sulcular Fluid Cortisol Level (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.