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NCT Number: NCT07312045

HALP Score, Blood-Based Inflammatory Indices, and Salivary MMP-8 in Periodontal Disease and Healing After Non-Surgical 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.

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Key information

Conditions

Periodontal Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Gingival Diseases Gingivitis Gingivitis; Chronic Graft vs Host Disease Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Mouth Diseases Organizing Pneumonia Periodontitis Respiratory Tract Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erzincan Binali Yıldırım University Faculty of Dentistry

Merkez, Erzincan, 24002, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ömer Faruk Okumuş, Assistant Professor

CONTACT

[email protected]

05532140969

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Non-surgical periodontal therapy

Procedure

Standard full-mouth supra- and subgingival debridement performed in a single session, followed by oral hygiene instructions.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Differences in Baseline NLR Between Good and Poor Responders

    Time frame: Baseline (T0)

    Comparison of baseline neutrophil-to-lymphocyte ratio between good and poor responders in the periodontitis group.

  2. Differences in Baseline PLR Between Good and Poor Responders

    Time frame: Baseline (T0)

    Comparison of baseline platelet-to-lymphocyte ratio between good and poor responders in the periodontitis group.

  3. Differences in Baseline LMR Between Good and Poor Responders

    Time frame: Baseline (T0)

    Comparison of baseline lymphocyte-to-monocyte ratio between good and poor responders in the periodontitis group.

  4. Differences in Baseline SII Between Good and Poor Responders

    Time frame: Baseline (T0)

    Comparison of baseline systemic immune-inflammation index between good and poor responders in the periodontitis group.

  5. Differences in Baseline Salivary MMP-8 Between Good and Poor Responders

    Time frame: Baseline (T0)

    Comparison of baseline salivary MMP-8 levels between good and poor responders in the periodontitis group.

  6. Baseline HALP Score Differences Across Periodontal Status Groups

    Time frame: Baseline (T0)

    Comparison of HALP score among healthy, gingivitis, and stage III/IV periodontitis groups.

  7. Baseline NLR Differences Across Periodontal Status Groups

    Time frame: Baseline (T0)

    Comparison of neutrophil-to-lymphocyte ratio among the three periodontal groups.

  8. Baseline PLR Differences Across Periodontal Status Groups

    Time frame: Baseline (T0)

    Comparison of platelet-to-lymphocyte ratio among the three periodontal groups.

  9. Baseline LMR Differences Across Periodontal Status Groups

    Time frame: Baseline (T0)

    Comparison of lymphocyte-to-monocyte ratio among the three periodontal groups.

  10. Baseline SII Differences Across Periodontal Status Groups

    Time frame: Baseline (T0)

    Comparison of systemic immune-inflammation index among the three periodontal groups.

  11. Baseline Salivary MMP-8 Differences Across Periodontal Status Groups

    Time frame: Baseline (T0)

    Comparison of salivary MMP-8 among healthy, gingivitis, and periodontitis groups.

  12. Changes in Probing Depth After Non-Surgical Periodontal Therapy

    Time frame: Baseline (T0) to 3 months (T2)

    Mean reduction in probing depth from baseline to 3 months in gingivitis and periodontitis patients.

  13. Change in HALP Score After Non-Surgical Periodontal Therapy in Periodontitis Patients

    Time frame: Baseline (T0) to 3 months (T2)

    Evaluation of the change in HALP score from baseline to 3 months after non-surgical periodontal therapy in patients with stage III/IV periodontitis.

  14. Correlations Between Clinical Periodontal Parameters and Biomarker Levels

    Time frame: Baseline (T0)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ömer Faruk Okumuş, Assistant Professor

CONTACT

[email protected]

+905532140969

Sponsors and collaborators

Lead sponsor

Ömer Faruk Okumuş

Other

Collaborators

  • Erzincan Binali Yildirim Universitesi

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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