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

Официальное название

The Relationship of HALP Score, Blood-Based Inflammatory Indices, and Salivary MMP-8 Levels With Periodontal Disease and Healing After Non-Surgical Periodontal Therapy

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Differences in Baseline HALP Score Between Good and Poor Treatment Responders [Срок оценки: Baseline (T0) to 3 months after treatment (T2)]

Вторичные конечные точки (12)

• Differences in Baseline NLR Between Good and Poor Responders [Срок оценки: Baseline (T0)]
• Differences in Baseline PLR Between Good and Poor Responders [Срок оценки: Baseline (T0)]
• Differences in Baseline LMR Between Good and Poor Responders [Срок оценки: Baseline (T0)]
• Differences in Baseline SII Between Good and Poor Responders [Срок оценки: Baseline (T0)]
• Differences in Baseline Salivary MMP-8 Between Good and Poor Responders [Срок оценки: Baseline (T0)]
• Baseline HALP Score Differences Across Periodontal Status Groups [Срок оценки: Baseline (T0)]
• Baseline NLR Differences Across Periodontal Status Groups [Срок оценки: Baseline (T0)]
• Baseline PLR Differences Across Periodontal Status Groups [Срок оценки: Baseline (T0)]
• Baseline LMR Differences Across Periodontal Status Groups [Срок оценки: Baseline (T0)]
• Baseline SII Differences Across Periodontal Status Groups [Срок оценки: Baseline (T0)]
• Baseline Salivary MMP-8 Differences Across Periodontal Status Groups [Срок оценки: Baseline (T0)]
• Changes in Probing Depth After Non-Surgical Periodontal Therapy [Срок оценки: Baseline (T0) to 3 months (T2)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Erzincan Binali Yıldırım University Faculty of Dentistry — Merkez

Идентификаторы

NCT: NCT07312045 · EBYU-HALP-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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