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

NCT07312045 | Recruiting

• 1 other identifier: EBYU-HALP-2025
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases; Periodontitis; Gingivitis; Chronic

Outcome Measures

Primary Outcomes (1)

• Differences in Baseline HALP Score Between Good and Poor Treatment Responders

  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.

  Baseline (T0) to 3 months after treatment (T2)

Secondary Outcomes (14)

• Differences in Baseline NLR Between Good and Poor Responders

  Baseline (T0)

• Differences in Baseline PLR 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)

Study Arms (3)

Periodontally Healthy Individuals

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.

Procedure: Non-surgical Periodontal Therapy

Gingivitis Patients

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.

Procedure: Non-surgical Periodontal Therapy

Stage III/IV Periodontitis Patients

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.

Procedure: Non-surgical Periodontal Therapy

Interventions

Non-surgical Periodontal Therapy PROCEDURE

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

Gingivitis Patients; Periodontally Healthy Individuals; Stage III/IV Periodontitis Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult individuals aged 18-65 years presenting to the periodontology clinic for routine examination or periodontal treatment. Participants will be assigned to healthy, gingivitis, or stage III/IV periodontitis groups based on periodontal diagnosis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ömer Faruk Okumuş: lead
• Erzincan Binali Yildirim Universitesi: collaborator

Study Sites (1)

Erzincan Binali Yıldırım University Faculty of Dentistry

Merkez, Erzincan, 24002, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Gingivitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ömer Faruk Okumuş, Assistant Professor

CONTACT

+905532140969; okumus.omer24@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 31, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

TU (1)