Periodontal DiseasePERIO-BIONCT07661784
Salivary Biomarkers in Periodontal Disease Progression
An observational study of Periodontal Disease and Gingivitis and Periodontal Diseases, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate salivary biomarkers associated with bone remodeling during the transition from periodontal health to disease. Periodontal diseases are characterized by chronic inflammation that can lead to connective tissue destruction and alveolar bone loss. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Gingivitis and Periodontal Diseases, Periodontitis
- What is being tested?
- Saliva Sampling
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2025to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 consists of systemically healthy adult individuals aged 18-65 years who attend the Department of Periodontology at Suleyman Demirel University for routine dental examination and periodontal evaluation. Participants will be classified into periodontally healthy, gingivitis, and periodontitis groups based on clinical periodontal findings.
Who may be able to join
- Adults aged 18-65 years Systemically healthy individuals Individuals classified as periodontally healthy, gingivitis, or periodontitis according to clinical periodontal examination Ability and willingness to provide informed consent
Who cannot join
- Presence of systemic diseases affecting periodontal status (e.g., diabetes mellitus, immunological disorders) Use of antibiotics or anti-inflammatory drugs within the last 3 months History of periodontal treatment within the last 6 months Pregnancy or lactation Smoking (optional ) Any condition that may affect salivary biomarker levels
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Suleyman Demirel University
Isparta, 32000
Süleyman Demirel Üniversitesi Süleyman Demirel Üniversitesi, +90 (246) 211 8859, tipetik@sdu.edu.tr
About this study
Official title: Evaluation of Salivary Biomarkers Associated With Bone Remodeling in the Transition From Periodontal Health to Disease
This study aims to evaluate salivary biomarkers associated with bone remodeling during the transition from periodontal health to disease. Periodontal diseases are characterized by chronic inflammation that can lead to connective tissue destruction and alveolar bone loss. Although diagnosis is primarily based on clinical and radiographic findings, these methods may not fully reflect disease activity or progression.
In this observational study, individuals with periodontal health, gingivitis, and periodontitis will be included. Salivary levels of IL-17, IL-23, IL-6, TGF-β, RANKL, and OPG will be measured using ELISA. The relationship between these biomarkers and periodontal disease stage and grade will be analyzed.
The results are expected to improve understanding of the biological mechanisms underlying periodontal disease progression and to assess the potential role of salivary biomarkers in early diagnosis and personalized treatment approaches.
Read the detailed description
Periodontal diseases are chronic inflammatory conditions characterized by progressive destruction of the supporting tissues of the teeth, including connective tissue and alveolar bone. The transition from periodontal health to disease involves complex interactions between the host immune response and microbial factors, leading to alterations in bone remodeling processes.
Recent evidence suggests that salivary biomarkers may provide valuable insights into disease activity and progression. In particular, cytokines such as interleukin (IL)-17, IL-23, and IL-6, as well as bone remodeling-related markers including transforming growth factor-beta (TGF-β), receptor activator of nuclear factor-kappa B ligand (RANKL), and osteoprotegerin (OPG), are thought to play critical roles in the pathogenesis of periodontal disease.
This observational study is designed to investigate the levels of these salivary biomarkers in individuals with periodontal health, gingivitis, and periodontitis. Participants will be classified according to established periodontal disease staging and grading criteria. Unstimulated saliva samples will be collected and analyzed using enzyme-linked immunosorbent assay (ELISA) methods.
The primary objective is to evaluate differences in biomarker levels among study groups and to assess their association with periodontal disease severity. Secondary analyses will explore correlations between biomarker profiles and clinical periodontal parameters.
The findings of this study are expected to contribute to a better understanding of the biological mechanisms underlying periodontal disease progression and to support the potential use of salivary biomarkers as non-invasive tools for early diagnosis and personalized treatment planning.
- Being tested
- Saliva Sampling
- Keywords
- Periodontal Disease, Gingivitis, Periodontitis, Salivary Biomarkers, Bone Remodeling, Interleukin-17 (IL-17), Interleukin-23 (IL-23), Interleukin-6 (IL-6), Transforming Growth Factor Beta (TGF-β), RANKL, Osteoprotegerin (OPG), ELISA, Non-invasive Diagnosis
- Medical subject headings
- Periodontal Diseases, Gingivitis, Periodontitis, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva SamplingOther
Collection of unstimulated saliva samples from participants for the analysis of inflammatory and bone remodeling-related biomarkers using ELISA methods.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy | Individuals with clinically healthy periodontal tissues, no signs of gingival inflammation, and no clinical attachment loss. Unstimulated saliva samples will be collected for biomarker analysis. Receives: Other: Saliva Sampling | |
| Gingivitis | Individuals diagnosed with gingivitis characterized by gingival inflammation without clinical attachment loss. Unstimulated saliva samples will be collected for biomarker analysis. Receives: Other: Saliva Sampling | |
| Periodontitis | Individuals diagnosed with periodontitis presenting clinical attachment loss and radiographic evidence of alveolar bone loss. Unstimulated saliva samples will be collected for biomarker analysis. Receives: Other: Saliva Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary concentrations of IL-17, IL-23, IL-6, TGF-β, RANKL and OPG
Salivary concentrations of IL-17, IL-23, IL-6, TGF-β, RANKL and OPG measured using enzyme-linked immunosorbent assay (ELISA). Biomarker concentrations will be reported in pg/mL and compared among periodontal health, gingivitis and periodontitis groups.
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 posted22 Jun 2026
- Study start10 Jul 2025
- Primary completion10 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erensu UZAR, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661784
- Sponsor's protocol ID
- TMA-2025-9701
- Acronym
- PERIO-BIO
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to privacy and ethical considerations. The study involves sensitive clinical and biological data, and sharing such information may compromise participant confidentiality.
Publications
Buduneli N, Kinane DF. Host-derived diagnostic markers related to soft tissue destruction and bone degradation in periodontitis. J Clin Periodontol. 2011 Mar;38 Suppl 11:85-105. doi: 10.1111/j.1600-051X.2010.01670.x.
PubMed 21323706Graves DT, Fine D, Teng YT, Van Dyke TE, Hajishengallis G. The use of rodent models to investigate host-bacteria interactions related to periodontal diseases. J Clin Periodontol. 2008 Feb;35(2):89-105. doi: 10.1111/j.1600-051X.2007.01172.x.
PubMed 18199146Kinney JS, Morelli T, Braun T, Ramseier CA, Herr AE, Sugai JV, Shelburne CE, Rayburn LA, Singh AK, Giannobile WV. Saliva/pathogen biomarker signatures and periodontal disease progression. J Dent Res. 2011 Jun;90(6):752-8. doi: 10.1177/0022034511399908. Epub 2011 Mar 15.
PubMed 21406610Dommisch H, Hoedke D, Lu EM, Schafer A, Richter G, Kang J, Nibali L. Genetic Biomarkers for Periodontal Diseases: A Systematic Review. J Clin Periodontol. 2025 Aug;52 Suppl 29(Suppl 29):182-210. doi: 10.1111/jcpe.14149. Epub 2025 Apr 8.
PubMed 40197750
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary Biomarkers Associated With Bone Remodeling in the Transition From Periodontal Health to Disease
- ClinicalTrials.gov ID
- NCT07661784
- Acronym / sponsor ID
- PERIO-BIO / TMA-2025-9701
- Keywords
- Periodontal Disease, Gingivitis, Periodontitis, Salivary Biomarkers, Bone Remodeling, Interleukin-17 (IL-17), Interleukin-23 (IL-23), Interleukin-6 (IL-6)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 22 Jun 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 aims to evaluate salivary biomarkers associated with bone remodeling during the transition from periodontal health to disease. Periodontal diseases are characterized by chronic inflammation that can lead to connective tissue destruction and alveolar bone loss. Although diagnosis is primarily based on clinical and radiographic findings, these methods may not fully reflect disease activity or progression.
In this observational study, individuals with periodontal health, gingivitis, and periodontitis will be included. Salivary levels of IL-17, IL-23, IL-6, TGF-β, RANKL, and OPG will be measured using ELISA. The relationship between these biomarkers and periodontal disease stage and grade will be analyzed.
The results are expected to improve understanding of the biological mechanisms underlying periodontal disease progression and to assess the potential role of salivary biomarkers in early diagnosis and personalized treatment approaches.
Detailed description
Periodontal diseases are chronic inflammatory conditions characterized by progressive destruction of the supporting tissues of the teeth, including connective tissue and alveolar bone. The transition from periodontal health to disease involves complex interactions between the host immune response and microbial factors, leading to alterations in bone remodeling processes.
Recent evidence suggests that salivary biomarkers may provide valuable insights into disease activity and progression. In particular, cytokines such as interleukin (IL)-17, IL-23, and IL-6, as well as bone remodeling-related markers including transforming growth factor-beta (TGF-β), receptor activator of nuclear factor-kappa B ligand (RANKL), and osteoprotegerin (OPG), are thought to play critical roles in the pathogenesis of periodontal disease.
This observational study is designed to investigate the levels of these salivary biomarkers in individuals with periodontal health, gingivitis, and periodontitis. Participants will be classified according to established periodontal disease staging and grading criteria. Unstimulated saliva samples will be collected and analyzed using enzyme-linked immunosorbent assay (ELISA) methods.
The primary objective is to evaluate differences in biomarker levels among study groups and to assess their association with periodontal disease severity. Secondary analyses will explore correlations between biomarker profiles and clinical periodontal parameters.
The findings of this study are expected to contribute to a better understanding of the biological mechanisms underlying periodontal disease progression and to support the potential use of salivary biomarkers as non-invasive tools for early diagnosis and personalized treatment planning.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy | – | Other: Saliva SamplingIndividuals with clinically healthy periodontal tissues, no signs of gingival inflammation, and no clinical attachment loss. Unstimulated saliva samples will be collected for biomarker analysis. |
| Gingivitis | – | Other: Saliva SamplingIndividuals diagnosed with gingivitis characterized by gingival inflammation without clinical attachment loss. Unstimulated saliva samples will be collected for biomarker analysis. |
| Periodontitis | – | Other: Saliva SamplingIndividuals diagnosed with periodontitis presenting clinical attachment loss and radiographic evidence of alveolar bone loss. Unstimulated saliva samples will be collected for biomarker analysis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of systemically healthy adult individuals aged 18-65 years who attend the Department of Periodontology at Suleyman Demirel University for routine dental examination and periodontal evaluation. Participants will be classified into periodontally healthy, gingivitis, and periodontitis groups based on clinical periodontal findings.
Key inclusion criteria (1 listed)
- Adults aged 18-65 years Systemically healthy individuals Individuals classified as periodontally healthy, gingivitis, or periodontitis according to clinical periodontal examination Ability and willingness to provide informed consent
Key exclusion criteria (1 listed)
- Presence of systemic diseases affecting periodontal status (e.g., diabetes mellitus, immunological disorders) Use of antibiotics or anti-inflammatory drugs within the last 3 months History of periodontal treatment within the last 6 months Pregnancy or lactation Smoking (optional ) Any condition that may affect salivary biomarker levels
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 |
|---|---|---|
| Saliva SamplingCollection of unstimulated saliva samples from participants for the analysis of inflammatory and bone remodeling-related biomarkers using ELISA methods. | Other | Gingivitis, Periodontally Healthy, Periodontitis |
Primary outcome
Salivary concentrations of IL-17, IL-23, IL-6, TGF-β, RANKL and OPG
Time frame: At baseline
Salivary concentrations of IL-17, IL-23, IL-6, TGF-β, RANKL and OPG measured using enzyme-linked immunosorbent assay (ELISA). Biomarker concentrations will be reported in pg/mL and compared among periodontal health, gingivitis and periodontitis groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 21323706Buduneli N, Kinane DF. Host-derived diagnostic markers related to soft tissue destruction and bone degradation in periodontitis. J Clin Periodontol. 2011 Mar;38 Suppl 11:85-105. doi: 10.1111/j.1600-051X.2010.01670.x.
- Background: PubMed 18199146Graves DT, Fine D, Teng YT, Van Dyke TE, Hajishengallis G. The use of rodent models to investigate host-bacteria interactions related to periodontal diseases. J Clin Periodontol. 2008 Feb;35(2):89-105. doi: 10.1111/j.1600-051X.2007.01172.x.
- Background: PubMed 21406610Kinney JS, Morelli T, Braun T, Ramseier CA, Herr AE, Sugai JV, Shelburne CE, Rayburn LA, Singh AK, Giannobile WV. Saliva/pathogen biomarker signatures and periodontal disease progression. J Dent Res. 2011 Jun;90(6):752-8. doi: 10.1177/0022034511399908. Epub 2011 Mar 15.
- Background: PubMed 40197750Dommisch H, Hoedke D, Lu EM, Schafer A, Richter G, Kang J, Nibali L. Genetic Biomarkers for Periodontal Diseases: A Systematic Review. J Clin Periodontol. 2025 Aug;52 Suppl 29(Suppl 29):182-210. doi: 10.1111/jcpe.14149. Epub 2025 Apr 8.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to privacy and ethical considerations. The study involves sensitive clinical and biological data, and sharing such information may compromise participant confidentiality.
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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.
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 Periodontal Disease and Gingivitis and Periodontal Diseases, run by Suleyman Demirel 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erensu Uzar Gürtan, DDS, PhD (+90 530 868 1519, erensu.uzar@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary concentrations of IL-17, IL-23, IL-6, TGF-β, RANKL and OPG (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07661784, which also lists 4 linked publications.
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 22 Jun 2026.