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

Ömer Faruk Okumuş

Status: Enrolling

Conditions: Periodontitis; Gingivitis; Chronic; Periodontal Diseases

Treatments: Procedure: Non-surgical Periodontal Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT07312045

EBYU-HALP-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

180 participants in 3 patient groups

Periodontally Healthy Individuals

Description:

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.

Treatment:

Procedure: Non-surgical Periodontal Therapy

Gingivitis Patients

Description:

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.

Treatment:

Procedure: Non-surgical Periodontal Therapy

Stage III/IV Periodontitis Patients

Description:

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.

Treatment:

Procedure: Non-surgical Periodontal Therapy