Peri-implantitisNCT07697729
Relationship Between Metrnl Expression, IL-1β, and TNF-α in Patients With Peri-Implantitis
An observational study of Peri-implantitis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Peri-implantitis is an inflammatory disease affecting the tissues around dental implants and may lead to progressive bone loss and implant failure. Current diagnosis is mainly based on clinical and radiographic findings, which may not fully reflect the underlying inflammatory activity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2026to 2 Aug 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adults with at least one functioning dental implant who are evaluated at the Department of Periodontology, Faculty of Dentistry, Atatürk University. Participants will be classified into two groups according to clinical and radiographic findings: individuals with peri-implantitis and individuals with peri-implant health. Peri-implant clinical parameters and peri-implant crevicular fluid biomarker levels will be evaluated and compared between the groups.
Who may be able to join
- Individuals aged 18 years or older
- Individuals without systemic disease
- Individuals with at least one healthy implant or one implant affected by peri-implantitis
- At least 1 year having elapsed since placement of the prosthetic restoration on the relevant implant
Who cannot join
- Pregnant or lactating individuals.
- Current smokers.
- Use of antibiotics or corticosteroids within the previous 6 months.
- Presence of an implant-supported removable prosthesis.
- Periodontal or peri-implant treatment within the previous 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Metrnl Expression With IL-1β and TNF-α in Patients With Peri-Implantitis: Potential as a Novel Biomarker
Peri-implantitis is an inflammatory disease affecting the tissues around dental implants and may lead to progressive bone loss and implant failure. Current diagnosis is mainly based on clinical and radiographic findings, which may not fully reflect the underlying inflammatory activity. Therefore, there is a need for biological markers that may provide additional information about disease-related changes.
This observational study aims to compare the levels of Meteorin-like protein (Metrnl) and selected inflammatory cytokines in peri-implant crevicular fluid obtained from individuals with peri-implantitis and individuals with healthy implants. The study will evaluate Metrnl, interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10). It will also examine the relationships between Metrnl and these inflammatory markers.
The study hypothesis is that Metrnl levels differ between healthy peri-implant tissues and peri-implantitis and are associated with pro-inflammatory and anti-inflammatory cytokine levels. The findings may help clarify the possible role of Metrnl in peri-implant inflammation and its potential as a biomarker for distinguishing peri-implant health from peri-implantitis.
Read the detailed description
Peri-implantitis is a biofilm-associated inflammatory disease characterized by inflammation of the peri-implant mucosa and progressive loss of supporting bone. Although clinical and radiographic parameters, including probing depth, bleeding on probing, suppuration, and radiographic bone loss, are central to diagnosis, these measures primarily reflect established tissue changes and may not fully characterize the underlying local immune-inflammatory response. Analysis of biomarkers in peri-implant crevicular fluid may therefore provide complementary information about the biological processes associated with peri-implant health and disease.
Meteorin-like protein (Metrnl) is an immunoregulatory protein involved in inflammatory regulation, macrophage polarization, and tissue repair. Experimental and clinical evidence suggests that Metrnl may interact with both pro-inflammatory and anti-inflammatory pathways. However, its possible role in peri-implantitis has not been sufficiently investigated.
This observational study will include individuals with peri-implantitis and individuals with healthy peri-implant tissues. Participants will be classified according to clinical and radiographic findings. Clinical periodontal and peri-implant parameters will be recorded to characterize the study groups. Peri-implant crevicular fluid samples will be collected from selected implant sites, and the concentrations of Metrnl, interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10) will be analyzed.
The primary objective is to compare Metrnl levels between the peri-implantitis and peri-implant health groups. Secondary objectives are to compare IL-1β, TNF-α, and IL-10 levels between the groups and to evaluate the relationships between Metrnl and these pro-inflammatory and anti-inflammatory cytokines. The study will also explore the ability of Metrnl and the evaluated cytokines to distinguish peri-implant health from peri-implantitis.
The study hypothesis is that Metrnl levels differ between peri-implant health and peri-implantitis and are associated with the local inflammatory cytokine profile. Evaluation of these relationships may provide new information about the role of Metrnl in the immunoinflammatory mechanisms of peri-implantitis and its potential value as a biomarker.
- Conditions
- Peri-implantitis
- Keywords
- Meteorin-Like Protein, Metrnl, Peri-Implant Crevicular Fluid, Interleukin-1 Beta, Tumor Necrosis Factor-Alpha, Interleukin-10, Dental Implants
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peri-Implantitis Group | Individuals diagnosed with peri-implantitis based on clinical and radiographic criteria. Peri-implant crevicular fluid samples will be collected, and Metrnl, IL-1β, TNF-α, and IL-10 levels will be evaluated. | |
| Peri-Implant Health Group | Individuals with clinically and radiographically healthy peri-implant tissues. Peri-implant crevicular fluid samples will be collected, and Metrnl, IL-1β, TNF-α, and IL-10 levels will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metrnl Concentration in Peri-Implant Crevicular Fluid
Meteorin-like protein (Metrnl) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in ng/mL. Metrnl concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.
Measured: At enrollment
Secondary outcomes (3)
IL-1β Concentration in Peri-Implant Crevicular Fluid
Interleukin-1 beta (IL-1β) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in pg/mL. IL-1β concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.
Measured: At enrollment
TNF-α Concentration in Peri-Implant Crevicular Fluid
Tumor necrosis factor-alpha (TNF-α) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in pg/mL. TNF-α concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.
Measured: At enrollment
IL-10 Concentration in Peri-Implant Crevicular Fluid
Interleukin-10 (IL-10) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in pg/mL. IL-10 concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start7 Jul 2026
- Primary completion1 Aug 2026
- Study completion2 Aug 2026
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 Ataturk 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Eser Tuna, Ataturk University
- Investigators
- Recep Orbak, DDS, PhD, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697729
- Sponsor's protocol ID
- 758
- Other IDs
- 15367
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Metrnl Expression With IL-1β and TNF-α in Patients With Peri-Implantitis: Potential as a Novel Biomarker
- ClinicalTrials.gov ID
- NCT07697729
- Acronym / sponsor ID
- 758
- Conditions
- Peri-implantitis
- Keywords
- Meteorin-Like Protein, Metrnl, Peri-Implant Crevicular Fluid, Interleukin-1 Beta, Tumor Necrosis Factor-Alpha, Interleukin-10, Dental Implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 2 Aug 2026 (actual)
- First posted
- 13 Jul 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.
Peri-implantitis is an inflammatory disease affecting the tissues around dental implants and may lead to progressive bone loss and implant failure. Current diagnosis is mainly based on clinical and radiographic findings, which may not fully reflect the underlying inflammatory activity. Therefore, there is a need for biological markers that may provide additional information about disease-related changes.
This observational study aims to compare the levels of Meteorin-like protein (Metrnl) and selected inflammatory cytokines in peri-implant crevicular fluid obtained from individuals with peri-implantitis and individuals with healthy implants. The study will evaluate Metrnl, interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10). It will also examine the relationships between Metrnl and these inflammatory markers.
The study hypothesis is that Metrnl levels differ between healthy peri-implant tissues and peri-implantitis and are associated with pro-inflammatory and anti-inflammatory cytokine levels. The findings may help clarify the possible role of Metrnl in peri-implant inflammation and its potential as a biomarker for distinguishing peri-implant health from peri-implantitis.
Detailed description
Peri-implantitis is a biofilm-associated inflammatory disease characterized by inflammation of the peri-implant mucosa and progressive loss of supporting bone. Although clinical and radiographic parameters, including probing depth, bleeding on probing, suppuration, and radiographic bone loss, are central to diagnosis, these measures primarily reflect established tissue changes and may not fully characterize the underlying local immune-inflammatory response. Analysis of biomarkers in peri-implant crevicular fluid may therefore provide complementary information about the biological processes associated with peri-implant health and disease.
Meteorin-like protein (Metrnl) is an immunoregulatory protein involved in inflammatory regulation, macrophage polarization, and tissue repair. Experimental and clinical evidence suggests that Metrnl may interact with both pro-inflammatory and anti-inflammatory pathways. However, its possible role in peri-implantitis has not been sufficiently investigated.
This observational study will include individuals with peri-implantitis and individuals with healthy peri-implant tissues. Participants will be classified according to clinical and radiographic findings. Clinical periodontal and peri-implant parameters will be recorded to characterize the study groups. Peri-implant crevicular fluid samples will be collected from selected implant sites, and the concentrations of Metrnl, interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10) will be analyzed.
The primary objective is to compare Metrnl levels between the peri-implantitis and peri-implant health groups. Secondary objectives are to compare IL-1β, TNF-α, and IL-10 levels between the groups and to evaluate the relationships between Metrnl and these pro-inflammatory and anti-inflammatory cytokines. The study will also explore the ability of Metrnl and the evaluated cytokines to distinguish peri-implant health from peri-implantitis.
The study hypothesis is that Metrnl levels differ between peri-implant health and peri-implantitis and are associated with the local inflammatory cytokine profile. Evaluation of these relationships may provide new information about the role of Metrnl in the immunoinflammatory mechanisms of peri-implantitis and its potential value as a biomarker.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-Implantitis Group | – | –Individuals diagnosed with peri-implantitis based on clinical and radiographic criteria. Peri-implant crevicular fluid samples will be collected, and Metrnl, IL-1β, TNF-α, and IL-10 levels will be evaluated. |
| Peri-Implant Health Group | – | –Individuals with clinically and radiographically healthy peri-implant tissues. Peri-implant crevicular fluid samples will be collected, and Metrnl, IL-1β, TNF-α, and IL-10 levels will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults with at least one functioning dental implant who are evaluated at the Department of Periodontology, Faculty of Dentistry, Atatürk University. Participants will be classified into two groups according to clinical and radiographic findings: individuals with peri-implantitis and individuals with peri-implant health. Peri-implant clinical parameters and peri-implant crevicular fluid biomarker levels will be evaluated and compared between the groups.
Key inclusion criteria (4 listed)
- Individuals aged 18 years or older
- Individuals without systemic disease
- Individuals with at least one healthy implant or one implant affected by peri-implantitis
- At least 1 year having elapsed since placement of the prosthetic restoration on the relevant implant
Key exclusion criteria (5 listed)
- Pregnant or lactating individuals.
- Current smokers.
- Use of antibiotics or corticosteroids within the previous 6 months.
- Presence of an implant-supported removable prosthesis.
- Periodontal or peri-implant treatment within the previous 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metrnl Concentration in Peri-Implant Crevicular Fluid
Time frame: At enrollment
Meteorin-like protein (Metrnl) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in ng/mL. Metrnl concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.
3 secondary outcomes
IL-1β Concentration in Peri-Implant Crevicular Fluid
Time frame: At enrollment
TNF-α Concentration in Peri-Implant Crevicular Fluid
Time frame: At enrollment
IL-10 Concentration in Peri-Implant Crevicular Fluid
Time frame: At enrollment
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 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Recep Orbak, DDS, PhD study director
Ataturk University
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, run by Ataturk 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 4 inclusion and 5 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 3 Sep 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?
Metrnl Concentration in Peri-Implant Crevicular Fluid (time frame: At enrollment). 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 3 Sep 2026.