Peri-Implant DiseasesNCT07813845
Salivary Biomarkers in Different Implant-Supported Prostheses
An observational study of Peri-Implant Diseases, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This observational cross-sectional study compared salivary biomarkers among adults with different types of implant-supported prosthetic rehabilitation and periodontally healthy adults with natural teeth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implant Diseases
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Feb 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: Adults attending the Department of Prosthodontics, Faculty of Dentistry, Akdeniz University were recruited and classified according to their existing dentition and prosthetic status. The study population included periodontally healthy fully dentate individuals without implants and patients rehabilitated with implant-supported partial fixed prostheses, full-arch fixed implant-supported prostheses, or implant-retained overdentures. Prosthetic rehabilitation was present before enrollment and was not assigned by the study protocol.
Who may be able to join
- Age 18 years or older.
- Ability and willingness to provide written informed consent.
- For the healthy dentate group: fully dentate individuals without dental implants who were systemically and periodontally healthy, with probing depths of 3 mm or less at all sites and full-mouth bleeding on probing below 10%.
- For the implant groups: presence of an implant-supported partial fixed prosthesis, full-arch fixed implant-supported prosthesis, or implant-retained overdenture with osseointegrated implants restored with a definitive prosthesis in function for at least 6 months.
Who cannot join
- Antibiotic use within the preceding 6 months.
- Periodontal therapy within the preceding 6 months.
- Systemic conditions known to affect periodontal or immune status, including diabetes mellitus, cardiovascular disease, rheumatoid arthritis, systemic lupus erythematosus, or inflammatory bowel disease.
- Systemic infectious diseases, including tuberculosis, hepatitis, or human immunodeficiency virus infection.
- Mucocutaneous diseases affecting the oral mucosa, including lichen planus, pemphigus vulgaris, or chronic ulcerative stomatitis.
- Ongoing systemic corticosteroid, immunosuppressant, or biologic therapy.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Dentistry
Antalya, Antalya, 07058
About this study
Official title: Structural Versus Adaptive Salivary Signatures Across Implant-Supported Prosthetic Configurations: A Cross-Sectional Comparison of sIgA, MMP-8, and MMP-9
This observational cross-sectional study compared salivary biomarkers among adults with different types of implant-supported prosthetic rehabilitation and periodontally healthy adults with natural teeth. A total of 107 participants were included in four groups: periodontally healthy individuals with natural teeth, patients with implant-supported partial fixed prostheses and remaining natural teeth, patients with full-arch fixed implant-supported prostheses, and patients with implant-retained overdentures.
The study measured three biomarkers in unstimulated whole saliva: secretory immunoglobulin A (sIgA), matrix metalloproteinase-8 (MMP-8), and matrix metalloproteinase-9 (MMP-9). These biomarkers are related to oral immune responses and tissue remodeling.
The main aim was to determine whether salivary biomarker levels differed according to dentition status and type of implant-supported prosthesis. The study also examined relationships between these biomarkers and clinical parameters, including probing depth. No experimental treatment or intervention was assigned by the study protocol.
Read the detailed description
This single-center, observational, cross-sectional study evaluated salivary biomarker profiles across different dentition statuses and implant-supported prosthetic configurations.
Participants were classified into four groups according to dentition status and type of prosthetic rehabilitation: periodontally healthy, fully dentate individuals without implants; patients with implant-supported partial fixed prostheses and remaining natural teeth; patients rehabilitated with full-arch fixed implant-supported prostheses; and patients rehabilitated with implant-retained overdentures.
Clinical examination included periodontal and peri-implant probing depth measurements. The numbers of natural teeth and dental implants were also recorded. Unstimulated whole saliva was collected under standardized conditions and analyzed for secretory immunoglobulin A (sIgA), matrix metalloproteinase-8 (MMP-8), and matrix metalloproteinase-9 (MMP-9) using enzyme-linked immunosorbent assay (ELISA).
The primary objective was to compare salivary concentrations of sIgA, MMP-8, and MMP-9 among the four groups. Secondary objectives were to evaluate associations between biomarker concentrations and clinical parameters and to explore the ability of these biomarkers to distinguish among different dentition statuses and prosthetic configurations.
Because the study was observational, participants were not assigned to any treatment, intervention, or prosthetic rehabilitation under the study protocol. All prosthetic rehabilitations were in place before study enrollment.
- Conditions
- Peri-Implant Diseases
- Keywords
- Salivary Biomarkers, Dental Implants, ımplant-Supported Prosthesis, Secretory Immunoglobulin A, MMP-8, MMP-9
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 |
|---|---|---|
| Periodontally Healthy Dentate Group | Periodontally healthy, fully dentate participants without dental implants. Periodontal health was defined according to the 2017 World Workshop classification, with probing depths of 3 mm or less at all sites and full-mouth bleeding on probing below 10%. | |
| Partial Fixed Prosthesis Group | Participants with remaining natural teeth and an implant-supported partial fixed prosthesis that had been in function for at least 6 months. | |
| Full-Arch Fixed Prosthesis Group | Participants rehabilitated with a full-arch fixed implant-supported prosthesis, with the definitive prosthesis in function for at least 6 months. | |
| Implant-Retained Overdenture Group | Participants rehabilitated with an implant-retained overdenture, with the definitive prosthesis in function for at least 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary MMP-9 Concentration
Concentration of matrix metalloproteinase-9 (MMP-9) in unstimulated whole saliva, measured using enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.
Measured: At saliva collection, a single time point at least 24 hours after the clinical examination.
Salivary MMP-8 Concentration
Concentration of matrix metalloproteinase-8 (MMP-8) in unstimulated whole saliva, measured using enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.
Measured: At saliva collection, a single time point at least 24 hours after the clinical examination.
Salivary Secretory Immunoglobulin A Concentration
Concentration of secretory immunoglobulin A (sIgA) in unstimulated whole saliva, measured using enzyme-linked immunosorbent assay (ELISA) and reported in µg/mL.
Measured: At saliva collection, a single time point at least 24 hours after the clinical examination.
Secondary outcomes (2)
Association Between Salivary Biomarkers and Probing Depth
Associations between salivary MMP-8, MMP-9, and sIgA concentrations and probing depth at natural teeth and dental implants, assessed using Spearman rank correlation coefficients.
Measured: Clinical probing depth measured at the study visit, with saliva collected at least 24 hours after the clinical examination.
Discriminative Ability of Salivary Biomarkers Across Study Groups
The ability of salivary MMP-8, MMP-9, and sIgA concentrations to discriminate between dentition and prosthetic configuration groups, evaluated using receiver operating characteristic (ROC) analysis and area under the curve (AUC).
Measured: At saliva collection, a single time point at least 24 hours after the clinical examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Aug 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implant DiseasesStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813845
- Sponsor's protocol ID
- TBAEK-768
- Other IDs
- TDH-2025-6927
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no data-sharing plan was established as part of the study protocol or informed consent process. Only aggregated, de-identified study results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Versus Adaptive Salivary Signatures Across Implant-Supported Prosthetic Configurations: A Cross-Sectional Comparison of sIgA, MMP-8, and MMP-9
- ClinicalTrials.gov ID
- NCT07813845
- Acronym / sponsor ID
- TBAEK-768
- Conditions
- Peri-Implant Diseases
- Keywords
- Salivary Biomarkers, Dental Implants, ımplant-Supported Prosthesis, Secretory Immunoglobulin A, MMP-8, MMP-9
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 10 Sep 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 observational cross-sectional study compared salivary biomarkers among adults with different types of implant-supported prosthetic rehabilitation and periodontally healthy adults with natural teeth. A total of 107 participants were included in four groups: periodontally healthy individuals with natural teeth, patients with implant-supported partial fixed prostheses and remaining natural teeth, patients with full-arch fixed implant-supported prostheses, and patients with implant-retained overdentures.
The study measured three biomarkers in unstimulated whole saliva: secretory immunoglobulin A (sIgA), matrix metalloproteinase-8 (MMP-8), and matrix metalloproteinase-9 (MMP-9). These biomarkers are related to oral immune responses and tissue remodeling.
The main aim was to determine whether salivary biomarker levels differed according to dentition status and type of implant-supported prosthesis. The study also examined relationships between these biomarkers and clinical parameters, including probing depth. No experimental treatment or intervention was assigned by the study protocol.
Detailed description
This single-center, observational, cross-sectional study evaluated salivary biomarker profiles across different dentition statuses and implant-supported prosthetic configurations.
Participants were classified into four groups according to dentition status and type of prosthetic rehabilitation: periodontally healthy, fully dentate individuals without implants; patients with implant-supported partial fixed prostheses and remaining natural teeth; patients rehabilitated with full-arch fixed implant-supported prostheses; and patients rehabilitated with implant-retained overdentures.
Clinical examination included periodontal and peri-implant probing depth measurements. The numbers of natural teeth and dental implants were also recorded. Unstimulated whole saliva was collected under standardized conditions and analyzed for secretory immunoglobulin A (sIgA), matrix metalloproteinase-8 (MMP-8), and matrix metalloproteinase-9 (MMP-9) using enzyme-linked immunosorbent assay (ELISA).
The primary objective was to compare salivary concentrations of sIgA, MMP-8, and MMP-9 among the four groups. Secondary objectives were to evaluate associations between biomarker concentrations and clinical parameters and to explore the ability of these biomarkers to distinguish among different dentition statuses and prosthetic configurations.
Because the study was observational, participants were not assigned to any treatment, intervention, or prosthetic rehabilitation under the study protocol. All prosthetic rehabilitations were in place before study enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy Dentate Group | – | –Periodontally healthy, fully dentate participants without dental implants. Periodontal health was defined according to the 2017 World Workshop classification, with probing depths of 3 mm or less at all sites and full-mouth bleeding on probing below 10%. |
| Partial Fixed Prosthesis Group | – | –Participants with remaining natural teeth and an implant-supported partial fixed prosthesis that had been in function for at least 6 months. |
| Full-Arch Fixed Prosthesis Group | – | –Participants rehabilitated with a full-arch fixed implant-supported prosthesis, with the definitive prosthesis in function for at least 6 months. |
| Implant-Retained Overdenture Group | – | –Participants rehabilitated with an implant-retained overdenture, with the definitive prosthesis in function for at least 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults attending the Department of Prosthodontics, Faculty of Dentistry, Akdeniz University were recruited and classified according to their existing dentition and prosthetic status. The study population included periodontally healthy fully dentate individuals without implants and patients rehabilitated with implant-supported partial fixed prostheses, full-arch fixed implant-supported prostheses, or implant-retained overdentures. Prosthetic rehabilitation was present before enrollment and was not assigned by the study protocol.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Ability and willingness to provide written informed consent.
- For the healthy dentate group: fully dentate individuals without dental implants who were systemically and periodontally healthy, with probing depths of 3 mm or less at all sites and full-mouth bleeding on probing below 10%.
- For the implant groups: presence of an implant-supported partial fixed prosthesis, full-arch fixed implant-supported prosthesis, or implant-retained overdenture with osseointegrated implants restored with a definitive prosthesis in function for at least 6 months.
Key exclusion criteria (7 listed)
- Antibiotic use within the preceding 6 months.
- Periodontal therapy within the preceding 6 months.
- Systemic conditions known to affect periodontal or immune status, including diabetes mellitus, cardiovascular disease, rheumatoid arthritis, systemic lupus erythematosus, or inflammatory bowel disease.
- Systemic infectious diseases, including tuberculosis, hepatitis, or human immunodeficiency virus infection.
- Mucocutaneous diseases affecting the oral mucosa, including lichen planus, pemphigus vulgaris, or chronic ulcerative stomatitis.
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
Salivary MMP-9 Concentration
Time frame: At saliva collection, a single time point at least 24 hours after the clinical examination.
Concentration of matrix metalloproteinase-9 (MMP-9) in unstimulated whole saliva, measured using enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.
Salivary MMP-8 Concentration
Time frame: At saliva collection, a single time point at least 24 hours after the clinical examination.
Concentration of matrix metalloproteinase-8 (MMP-8) in unstimulated whole saliva, measured using enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.
Salivary Secretory Immunoglobulin A Concentration
Time frame: At saliva collection, a single time point at least 24 hours after the clinical examination.
Concentration of secretory immunoglobulin A (sIgA) in unstimulated whole saliva, measured using enzyme-linked immunosorbent assay (ELISA) and reported in µg/mL.
2 secondary outcomes
Association Between Salivary Biomarkers and Probing Depth
Time frame: Clinical probing depth measured at the study visit, with saliva collected at least 24 hours after the clinical examination.
Discriminative Ability of Salivary Biomarkers Across Study Groups
Time frame: At saliva collection, a single time point at least 24 hours after the clinical examination.
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 10 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no data-sharing plan was established as part of the study protocol or informed consent process. Only aggregated, de-identified study results will be reported.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diseases, run by Akdeniz 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 7 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 10 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?
Salivary MMP-9 Concentration (time frame: At saliva collection, a single time point at least 24 hours after the clinical examination.). 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 10 Sep 2026.