Peri-implant Bone LossNCT07584759
Evaluation of Fluid Biomarkers Around Implants Exhibiting Early Stage Periimplant Bone Loss
An observational study of Peri-implant Bone Loss and Peri-implant Marginal Bone Loss, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare biological mediators known to be important in peri-implant diseases in implants with and without early stage marginal bone loss. A total of 118 implants in 59 patients were designated as test and control groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Bone Loss, Peri-implant Marginal Bone Loss, Marginal Bone Loss
- What is being tested?
- Collecting of peri-implant sulcus fluid and Periapical radiography
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2025to 6 Sep 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who received implant treatment at the Department of Periodontology, Pamukkale University Faculty of Dentistry.
Who may be able to join
- Presence of 1 mm or more of radiographic marginal bone loss within the first 3 months after implant placement
- Availability of radiographic documentation
- Availability of demographic data, surgical records, and data related to the implant used
- Physical condition classified as Class I and II according to the American Society of Anesthesiologists (ASA) classification
- Patients with no smoking history in the last 10 years
- Fixed implant-supported restorations
- Screw-retained implants
Who cannot join
- Patients receiving and/or maintaining implant treatment at centers other than the Department of Periodontology, Pamukkale University Faculty of Dentistry
- Patients with incomplete or unreachable files or radiographic documentation
- Patients with a known systemic disease/condition that alters their physical condition or bone metabolism
- Severe bruxism cases
- Pregnant and breastfeeding patients
- Patients with incomplete implant-supported prosthesis
Show all 10Show fewer
- Areas grafted during or before implant surgery
- Removable implant-supported restorations
- Cement-retained implants
- Patients undergoing peri-implantitis treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University, Faculty of Dentistry, Periodontology
Denizli, 20160
About this study
Official title: Evaluation of Biomarkers Involved In Bone Metabolism (Remodeling) In Periimplanter Crevicular Fluid of Implants With Early Marginal Bone Loss: A Retrospective Clinical Study
This study aimed to compare biological mediators known to be important in peri-implant diseases in implants with and without early stage marginal bone loss. A total of 118 implants in 59 patients were designated as test and control groups. The radiographic and periodontal data of the included implants, along with peri-implant sulcus fluid samples, were evaluated.
Read the detailed description
This study included clinical and radiographic records of patients who received implant treatment in the maxilla and/or mandible between 11/2021 and 9/2024. Patients were divided into test and control groups based on the presence/absence of EMBL after prosthetic loading. Periodontal clinical measurements were recorded and peri-implant sulcus fluid (PISF) samples were collected. Sclerostin, calprotectin, type I collagen cross-linked N-telopeptide (NTx), matrix metalloproteinase (MMP)-8, and MMP-9 levels were analyzed using ELISA. Group comparisons were performed with the statistical analyses.
- Conditions
- Peri-implant Bone Loss, Peri-implant Marginal Bone Loss, Marginal Bone Loss, Peri-Implant Health
- Being tested
- Collecting of peri-implant sulcus fluid, Periapical radiography
- Keywords
- implant, marginal bone loss, peri-implant sulcular fluid, sclerostin, calprotectin, matrix metalloproteinases, n-terminal type I collagen telopeptide
- Medical subject headings
- Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting of peri-implant sulcus fluidOther
To evaluate biomarkers associated with peri-implant bone loss, periopaper was placed in the peri-implant pocket and absorbed with sulcus fluid.
Periapical radiographyDiagnostic test
Parallel cone technique was used during periapical imaging to accurately measure peri-implant bone loss.
| Study group | Role | What they receive |
|---|---|---|
| Test | Presence of marginal bone loss of 1 mm or more within the first 3 months after implant placement Receives: Other: Collecting of peri-implant sulcus fluid; Diagnostic Test: Periapical radiography | |
| Control | Presence of less than 1 mm of marginal bone loss within the first 3 months after implant placement Receives: Other: Collecting of peri-implant sulcus fluid; Diagnostic Test: Periapical radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calprotectin levels in peri-implant crevicular fluid
After collecting peri-implant sulcus fluid using the paper strip method, calprotectin levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
Measured: 6-8 week after prosthetic treatment
Sclerostin levels in peri-implant crevicular fluid
After collecting peri-implant sulcus fluid using the paper strip method, sclerostin levels in the peri-implant sulcus region were determined using the ELISA method and recorded in pg/ml.
Measured: 6-8 week after prosthetic treatment
NTx levels in peri-implant crevicular fluid
After collecting peri-implant sulcus fluid using the paper strip method, NTx levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
Measured: 6-8 week after prosthetic treatment
MMP-8 levels in peri-implant crevicular fluid
After collecting peri-implant sulcus fluid using the paper strip method, MMP-8 levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
Measured: 6-8 week after prosthetic treatment
MMP-9 levels in peri-implant crevicular fluid
After collecting peri-implant sulcus fluid using the paper strip method, MMP-9 levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
Measured: 6-8 week after prosthetic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start6 Mar 2025
- Primary completion6 Sep 2025
- Study completion6 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Bone LossStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raziye Tugce Can Keles, Pamukkale University
- Investigators
- Raziye Tugce Can Keles, R.A., Principal investigator, Pamukkale University Faculty of Dentistry, Department of PeriodontologyGizem Torumtay Cin, Assoc. Prof., Study director, Pamukkale University Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584759
- Sponsor's protocol ID
- E-60116787-020-604271
- Other IDs
- 2025DİŞF001
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biomarkers Involved In Bone Metabolism (Remodeling) In Periimplanter Crevicular Fluid of Implants With Early Marginal Bone Loss: A Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT07584759
- Acronym / sponsor ID
- E-60116787-020-604271
- Conditions
- Peri-implant Bone Loss, Peri-implant Marginal Bone Loss, Marginal Bone Loss, Peri-Implant Health
- Keywords
- implant, marginal bone loss, peri-implant sulcular fluid, sclerostin, calprotectin, matrix metalloproteinases, n-terminal type I collagen telopeptide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 6 Sep 2025 (actual)
- Study completion
- 6 Sep 2025 (actual)
- First posted
- 13 May 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 aimed to compare biological mediators known to be important in peri-implant diseases in implants with and without early stage marginal bone loss. A total of 118 implants in 59 patients were designated as test and control groups. The radiographic and periodontal data of the included implants, along with peri-implant sulcus fluid samples, were evaluated.
Detailed description
This study included clinical and radiographic records of patients who received implant treatment in the maxilla and/or mandible between 11/2021 and 9/2024. Patients were divided into test and control groups based on the presence/absence of EMBL after prosthetic loading. Periodontal clinical measurements were recorded and peri-implant sulcus fluid (PISF) samples were collected. Sclerostin, calprotectin, type I collagen cross-linked N-telopeptide (NTx), matrix metalloproteinase (MMP)-8, and MMP-9 levels were analyzed using ELISA. Group comparisons were performed with the statistical analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | – | Other: Collecting of peri-implant sulcus fluid, Diagnostic Test: Periapical radiographyPresence of marginal bone loss of 1 mm or more within the first 3 months after implant placement |
| Control | – | Other: Collecting of peri-implant sulcus fluid, Diagnostic Test: Periapical radiographyPresence of less than 1 mm of marginal bone loss within the first 3 months after implant placement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received implant treatment at the Department of Periodontology, Pamukkale University Faculty of Dentistry.
Key inclusion criteria (7 listed)
- Presence of 1 mm or more of radiographic marginal bone loss within the first 3 months after implant placement
- Availability of radiographic documentation
- Availability of demographic data, surgical records, and data related to the implant used
- Physical condition classified as Class I and II according to the American Society of Anesthesiologists (ASA) classification
- Patients with no smoking history in the last 10 years
Key exclusion criteria (10 listed)
- Patients receiving and/or maintaining implant treatment at centers other than the Department of Periodontology, Pamukkale University Faculty of Dentistry
- Patients with incomplete or unreachable files or radiographic documentation
- Patients with a known systemic disease/condition that alters their physical condition or bone metabolism
- Severe bruxism cases
- Pregnant and breastfeeding patients
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 |
|---|---|---|
| Collecting of peri-implant sulcus fluidTo evaluate biomarkers associated with peri-implant bone loss, periopaper was placed in the peri-implant pocket and absorbed with sulcus fluid. | Other | Control, Test |
| Periapical radiographyParallel cone technique was used during periapical imaging to accurately measure peri-implant bone loss. | Diagnostic test | Control, Test |
Primary outcome
Calprotectin levels in peri-implant crevicular fluid
Time frame: 6-8 week after prosthetic treatment
After collecting peri-implant sulcus fluid using the paper strip method, calprotectin levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
Sclerostin levels in peri-implant crevicular fluid
Time frame: 6-8 week after prosthetic treatment
After collecting peri-implant sulcus fluid using the paper strip method, sclerostin levels in the peri-implant sulcus region were determined using the ELISA method and recorded in pg/ml.
NTx levels in peri-implant crevicular fluid
Time frame: 6-8 week after prosthetic treatment
After collecting peri-implant sulcus fluid using the paper strip method, NTx levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
MMP-8 levels in peri-implant crevicular fluid
Time frame: 6-8 week after prosthetic treatment
After collecting peri-implant sulcus fluid using the paper strip method, MMP-8 levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
MMP-9 levels in peri-implant crevicular fluid
Time frame: 6-8 week after prosthetic treatment
After collecting peri-implant sulcus fluid using the paper strip method, MMP-9 levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
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 13 May 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.
Raziye Tugce Can Keles, R.A. principal investigator
Pamukkale University Faculty of Dentistry, Department of Periodontology
Gizem Torumtay Cin, Assoc. Prof. study director
Pamukkale University Faculty of Dentistry, Department of Periodontology
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-implant Bone Loss and Peri-implant Marginal Bone Loss, run by Pamukkale 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 7 inclusion and 10 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 13 May 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?
Calprotectin levels in peri-implant crevicular fluid (time frame: 6-8 week after prosthetic treatment). The study lists 5 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 13 May 2026.