Menu
Recruiting NCT07312045

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

Observational Periodontal Diseases Periodontitis Gingivitis; Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-surgical Periodontal Therapy.
Who it may be relevant to
Registry conditions: Periodontal Diseases, Periodontitis, Gingivitis; Chronic. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Procedure Non-surgical Periodontal Therapy
    Standard full-mouth supra- and subgingival debridement performed in a single session, followed by oral hygiene instructions.

Primary outcome measures

  • Differences in Baseline HALP Score Between Good and Poor Treatment Responders [Time frame: Baseline (T0) to 3 months after treatment (T2)]
Secondary outcome measures (12)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Erzincan Binali Yıldırım University Faculty of Dentistry — Merkez

Identifiers

NCT: NCT07312045 · EBYU-HALP-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗