Periodontal DiseasesNCT07312045
HALP Score, Blood-Based Inflammatory Indices, and Salivary MMP-8 in Periodontal Disease and Healing After Non-Surgical Therapy
An observational study of Periodontal Diseases and Periodontitis, run by Ömer Faruk Okumuş at 1 site in Turkey (Türkiye).
Trial summary
This observational clinical study aims to investigate the relationship between the HALP score (Hemoglobin × Albumin × Lymphocyte / Platelet), several blood-based inflammatory indices (including NLR, PLR, LMR, and SII), and salivary MMP-8 levels in individuals with periodontal health, gingivitis, and stage III/IV… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Gingivitis; Chronic
- What is being tested?
- Non-surgical Periodontal Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2025to 25 Nov 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: Adult individuals aged 18-65 years presenting to the periodontology clinic for routine examination or periodontal treatment. Participants will be assigned to healthy, gingivitis, or stage III/IV periodontitis groups based on periodontal diagnosis.
Who may be able to join
- Adults aged 18-65 years
- Ability to provide informed consent
- No systemic diseases or conditions affecting periodontal status
- For Healthy Group: Probing depth ≤3 mm, no attachment loss, no radiographic bone loss
- For Gingivitis Group: Gingival inflammation and bleeding on probing without attachment loss or bone loss
- For Periodontitis Group: Stage III or stage IV periodontitis according to 2018 classification
- No periodontal treatment within the past 6 months
- Willingness to attend follow-up visits
Who cannot join
- Systemic diseases influencing periodontal inflammation (e.g., diabetes, autoimmune disorders)
- Current pregnancy or lactation
- Use of antibiotics, anti-inflammatory medications, or immunosuppressive drugs within the last 3 months
- Smokers or individuals using tobacco products
- History of periodontal surgery in the last 6 months
- Presence of fewer than 20 natural teeth
- Any condition that may interfere with study participation or data reliability
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
Erzincan Binali Yıldırım University Faculty of Dentistry
Merkez, Erzincan, 24002
Ömer Faruk Okumuş, Assistant Professor, 05532140969, okumus.omer24@gmail.com
About this study
Official title: The Relationship of HALP Score, Blood-Based Inflammatory Indices, and Salivary MMP-8 Levels With Periodontal Disease and Healing After Non-Surgical Periodontal Therapy
This observational clinical study aims to investigate the relationship between the HALP score (Hemoglobin × Albumin × Lymphocyte / Platelet), several blood-based inflammatory indices (including NLR, PLR, LMR, and SII), and salivary MMP-8 levels in individuals with periodontal health, gingivitis, and stage III/IV periodontitis. The study also evaluates how these biomarkers relate to healing following non-surgical periodontal therapy.
A total of 180 participants aged 18-65 years will be included: 50 healthy individuals, 50 patients with gingivitis, and 80 patients with stage III/IV periodontitis. All participants will undergo periodontal clinical examination and provide blood and saliva samples at baseline. Individuals in the gingivitis and periodontitis groups will receive standard non-surgical periodontal treatment (full-mouth debridement) and will return for a 3-month follow-up visit, where periodontal measurements will be repeated. In the periodontitis group, an additional blood sample will be collected at the 3-month follow-up visit.
The primary objective is to determine whether baseline HALP score, systemic inflammatory indices, and salivary MMP-8 levels differ between participants who show good versus poor healing after treatment. Secondary objective include comparing biomarker levels across periodontal status groups. The findings may contribute to early prediction of treatment response and personalized periodontal care.
Read the detailed description
Following baseline assessments, participants in the gingivitis and periodontitis groups will receive standard non-surgical periodontal therapy. Periodontal clinical measurements will be repeated at the 3-month follow-up visit in these groups. In accordance with the existing ethics committee approval and following further feasibility assessment, an additional blood sample will be collected at the 3-month follow-up visit exclusively from participants in the periodontitis group.
- Conditions
- Periodontal Diseases, Periodontitis, Gingivitis; Chronic
- Being tested
- Non-surgical Periodontal Therapy
- Medical subject headings
- Periodontal Diseases, Periodontitis, Gingivitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical Periodontal TherapyProcedure or surgery
Standard full-mouth supra- and subgingival debridement performed in a single session, followed by oral hygiene instructions.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy Individuals | Participants with no clinical signs of gingival inflammation, probing depth ≤3 mm, no clinical attachment loss, and no radiographic bone loss. These individuals serve as the healthy control group. Receives: Procedure: Non-surgical Periodontal Therapy | |
| Gingivitis Patients | Participants with visible signs of gingival inflammation and bleeding on probing, but without clinical attachment loss or radiographic bone loss. These individuals will receive standard non-surgical periodontal therapy. Receives: Procedure: Non-surgical Periodontal Therapy | |
| Stage III/IV Periodontitis Patients | Participants diagnosed with stage III or stage IV periodontitis, characterized by clinical attachment loss, probing depth ≥5 mm, and radiographic bone loss. These individuals will receive standard non-surgical periodontal therapy and will be re-evaluated at 3 months. Receives: Procedure: Non-surgical Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Baseline HALP Score Between Good and Poor Treatment Responders
Evaluation of whether baseline HALP score differs between good responders (>2 mm reduction in probing depth at sites ≥5 mm) and poor responders (≤2 mm reduction) following non-surgical periodontal therapy in periodontitis patients.
Measured: Baseline (T0) to 3 months after treatment (T2)
Secondary outcomes (14)
Differences in Baseline NLR Between Good and Poor Responders
Comparison of baseline neutrophil-to-lymphocyte ratio between good and poor responders in the periodontitis group.
Measured: Baseline (T0)
Differences in Baseline PLR Between Good and Poor Responders
Comparison of baseline platelet-to-lymphocyte ratio between good and poor responders in the periodontitis group.
Measured: Baseline (T0)
Differences in Baseline LMR Between Good and Poor Responders
Comparison of baseline lymphocyte-to-monocyte ratio between good and poor responders in the periodontitis group.
Measured: Baseline (T0)
Differences in Baseline SII Between Good and Poor Responders
Comparison of baseline systemic immune-inflammation index between good and poor responders in the periodontitis group.
Measured: Baseline (T0)
Differences in Baseline Salivary MMP-8 Between Good and Poor Responders
Comparison of baseline salivary MMP-8 levels between good and poor responders in the periodontitis group.
Measured: Baseline (T0)
Baseline HALP Score Differences Across Periodontal Status Groups
Comparison of HALP score among healthy, gingivitis, and stage III/IV periodontitis groups.
Measured: Baseline (T0)
Baseline NLR Differences Across Periodontal Status Groups
Comparison of neutrophil-to-lymphocyte ratio among the three periodontal groups.
Measured: Baseline (T0)
Baseline PLR Differences Across Periodontal Status Groups
Comparison of platelet-to-lymphocyte ratio among the three periodontal groups.
Measured: Baseline (T0)
Baseline LMR Differences Across Periodontal Status Groups
Comparison of lymphocyte-to-monocyte ratio among the three periodontal groups.
Measured: Baseline (T0)
Baseline SII Differences Across Periodontal Status Groups
Comparison of systemic immune-inflammation index among the three periodontal groups.
Measured: Baseline (T0)
Baseline Salivary MMP-8 Differences Across Periodontal Status Groups
Comparison of salivary MMP-8 among healthy, gingivitis, and periodontitis groups.
Measured: Baseline (T0)
Changes in Probing Depth After Non-Surgical Periodontal Therapy
Mean reduction in probing depth from baseline to 3 months in gingivitis and periodontitis patients.
Measured: Baseline (T0) to 3 months (T2)
Change in HALP Score After Non-Surgical Periodontal Therapy in Periodontitis Patients
Evaluation of the change in HALP score from baseline to 3 months after non-surgical periodontal therapy in patients with stage III/IV periodontitis.
Measured: Baseline (T0) to 3 months (T2)
Correlations Between Clinical Periodontal Parameters and Biomarker Levels
Assessment of correlations between probing depth, bleeding on probing, plaque index, clinical attachment level, and biomarkers including HALP score, NLR, PLR, LMR, SII, and salivary MMP-8.
Measured: Baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start25 Nov 2025
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ömer Faruk Okumuş
- Sponsor type
- University, hospital or other
- Collaborators
- Erzincan Binali Yildirim Universitesi
- Responsible party
- Sponsor-investigator, Ömer Faruk Okumuş, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312045
- Sponsor's protocol ID
- EBYU-HALP-2025
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of HALP Score, Blood-Based Inflammatory Indices, and Salivary MMP-8 Levels With Periodontal Disease and Healing After Non-Surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT07312045
- Acronym / sponsor ID
- EBYU-HALP-2025
- Conditions
- Periodontal Diseases, Periodontitis, Gingivitis; Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ömer Faruk OkumuşUniversity, hospital or other
- Collaborators
- Erzincan Binali Yildirim Universitesi
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 31 Dec 2025 (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 clinical study aims to investigate the relationship between the HALP score (Hemoglobin × Albumin × Lymphocyte / Platelet), several blood-based inflammatory indices (including NLR, PLR, LMR, and SII), and salivary MMP-8 levels in individuals with periodontal health, gingivitis, and stage III/IV periodontitis. The study also evaluates how these biomarkers relate to healing following non-surgical periodontal therapy.
A total of 180 participants aged 18-65 years will be included: 50 healthy individuals, 50 patients with gingivitis, and 80 patients with stage III/IV periodontitis. All participants will undergo periodontal clinical examination and provide blood and saliva samples at baseline. Individuals in the gingivitis and periodontitis groups will receive standard non-surgical periodontal treatment (full-mouth debridement) and will return for a 3-month follow-up visit, where periodontal measurements will be repeated. In the periodontitis group, an additional blood sample will be collected at the 3-month follow-up visit.
The primary objective is to determine whether baseline HALP score, systemic inflammatory indices, and salivary MMP-8 levels differ between participants who show good versus poor healing after treatment. Secondary objective include comparing biomarker levels across periodontal status groups. The findings may contribute to early prediction of treatment response and personalized periodontal care.
Detailed description
Following baseline assessments, participants in the gingivitis and periodontitis groups will receive standard non-surgical periodontal therapy. Periodontal clinical measurements will be repeated at the 3-month follow-up visit in these groups. In accordance with the existing ethics committee approval and following further feasibility assessment, an additional blood sample will be collected at the 3-month follow-up visit exclusively from participants in the periodontitis group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy Individuals | – | Procedure: Non-surgical Periodontal TherapyParticipants with no clinical signs of gingival inflammation, probing depth ≤3 mm, no clinical attachment loss, and no radiographic bone loss. These individuals serve as the healthy control group. |
| Gingivitis Patients | – | Procedure: Non-surgical Periodontal TherapyParticipants with visible signs of gingival inflammation and bleeding on probing, but without clinical attachment loss or radiographic bone loss. These individuals will receive standard non-surgical periodontal therapy. |
| Stage III/IV Periodontitis Patients | – | Procedure: Non-surgical Periodontal TherapyParticipants diagnosed with stage III or stage IV periodontitis, characterized by clinical attachment loss, probing depth ≥5 mm, and radiographic bone loss. These individuals will receive standard non-surgical periodontal therapy and will be re-evaluated at 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult individuals aged 18-65 years presenting to the periodontology clinic for routine examination or periodontal treatment. Participants will be assigned to healthy, gingivitis, or stage III/IV periodontitis groups based on periodontal diagnosis.
Key inclusion criteria (8 listed)
- Adults aged 18-65 years
- Ability to provide informed consent
- No systemic diseases or conditions affecting periodontal status
- For Healthy Group: Probing depth ≤3 mm, no attachment loss, no radiographic bone loss
- For Gingivitis Group: Gingival inflammation and bleeding on probing without attachment loss or bone loss
Key exclusion criteria (7 listed)
- Systemic diseases influencing periodontal inflammation (e.g., diabetes, autoimmune disorders)
- Current pregnancy or lactation
- Use of antibiotics, anti-inflammatory medications, or immunosuppressive drugs within the last 3 months
- Smokers or individuals using tobacco products
- History of periodontal surgery in the last 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical Periodontal TherapyStandard full-mouth supra- and subgingival debridement performed in a single session, followed by oral hygiene instructions. | Procedure or surgery | Gingivitis Patients, Periodontally Healthy Individuals, Stage III/IV Periodontitis Patients |
Primary outcome
Differences in Baseline HALP Score Between Good and Poor Treatment Responders
Time frame: Baseline (T0) to 3 months after treatment (T2)
Evaluation of whether baseline HALP score differs between good responders (>2 mm reduction in probing depth at sites ≥5 mm) and poor responders (≤2 mm reduction) following non-surgical periodontal therapy in periodontitis patients.
14 secondary outcomes
Differences in Baseline NLR Between Good and Poor Responders
Time frame: Baseline (T0)
Differences in Baseline PLR Between Good and Poor Responders
Time frame: Baseline (T0)
Differences in Baseline LMR Between Good and Poor Responders
Time frame: Baseline (T0)
Differences in Baseline SII Between Good and Poor Responders
Time frame: Baseline (T0)
Differences in Baseline Salivary MMP-8 Between Good and Poor Responders
Time frame: Baseline (T0)
Baseline HALP Score Differences Across Periodontal Status Groups
Time frame: Baseline (T0)
Baseline NLR Differences Across Periodontal Status Groups
Time frame: Baseline (T0)
Baseline PLR Differences Across Periodontal Status Groups
Time frame: Baseline (T0)
Baseline LMR Differences Across Periodontal Status Groups
Time frame: Baseline (T0)
Baseline SII Differences Across Periodontal Status Groups
Time frame: Baseline (T0)
Baseline Salivary MMP-8 Differences Across Periodontal Status Groups
Time frame: Baseline (T0)
Changes in Probing Depth After Non-Surgical Periodontal Therapy
Time frame: Baseline (T0) to 3 months (T2)
Change in HALP Score After Non-Surgical Periodontal Therapy in Periodontitis Patients
Time frame: Baseline (T0) to 3 months (T2)
Correlations Between Clinical Periodontal Parameters and Biomarker Levels
Time frame: Baseline (T0)
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 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 Diseases and Periodontitis, run by Ömer Faruk Okumuş 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 8 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. 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 Ömer Faruk Okumuş, Assistant Professor (+905532140969, okumus.omer24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Baseline HALP Score Between Good and Poor Treatment Responders (time frame: Baseline (T0) to 3 months after treatment (T2)). 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 31 Dec 2025.