The Relationship of HALP Score, Blood-Based Inflammatory Indices, and Salivary MMP-8 Levels With Periodontal Disease and Healing After Non-Surgical Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Differences in Baseline HALP Score Between Good and Poor Treatment Responders
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Differences in Baseline HALP Score Between Good and Poor Treatment Responders
时间窗: 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.
次要结局
- Differences in Baseline PLR Between Good and Poor Responders(Baseline (T0))
- Differences in Baseline NLR Between Good and Poor Responders(Baseline (T0))
- Differences in Baseline LMR Between Good and Poor Responders(Baseline (T0))
- Differences in Baseline SII Between Good and Poor Responders(Baseline (T0))
- Differences in Baseline Salivary MMP-8 Between Good and Poor Responders(Baseline (T0))
- Baseline HALP Score Differences Across Periodontal Status Groups(Baseline (T0))
- Baseline NLR Differences Across Periodontal Status Groups(Baseline (T0))
- Baseline PLR Differences Across Periodontal Status Groups(Baseline (T0))
- Baseline LMR Differences Across Periodontal Status Groups(Baseline (T0))
- Baseline SII Differences Across Periodontal Status Groups(Baseline (T0))
- Baseline Salivary MMP-8 Differences Across Periodontal Status Groups(Baseline (T0))
- Changes in Probing Depth After Non-Surgical Periodontal Therapy(Baseline (T0) to 3 months (T2))
- Change in HALP Score After Non-Surgical Periodontal Therapy in Periodontitis Patients(Baseline (T0) to 3 months (T2))
- Correlations Between Clinical Periodontal Parameters and Biomarker Levels(Baseline (T0))
研究者
Ömer Faruk Okumuş
Assistant Professor
Erzincan University