Non-surgical Periodontitis Treatment With Aspirin and Omega-3

• Rationale Periodontitis is a chronic inflammatory disease caused by the host's immune response to pathogenic microorganisms, leading to clinical attachment loss and alveolar bone destruction. While non-surgical periodontal therapy (Scaling and Root Planing - SRP) is the gold standard, some patients experience disease progression due to residual subgingival biofilms.

This study explores Host Modulation Therapy (HMT) as an adjunct to SRP. The combination of Omega-3 fatty acids and low-dose Aspirin (81mg) is hypothesized to enhance the resolution of inflammation. Omega-3 serves as a substrate for pro-resolving mediators (Resolvins, Protectins, Maresins), while Aspirin triggers the synthesis of Aspirin-triggered Lipoxins via the COX-2 pathway. This synergistic approach aims to reduce systemic pro-inflammatory markers, specifically Interleukin-6 (IL-6) and C-reactive protein (CRP), and improve clinical healing.

• Detailed Study Design This is a randomized controlled clinical trial involving 120 participants. Randomization: Participants who meet the inclusion criteria are randomly assigned to one of three groups (1:1:1 ratio). Randomization is performed using Excel software (RAND function) to generate a random sequence.

Allocation Concealment: Group assignments are placed in sealed, opaque envelopes and managed by a researcher not directly involved in the clinical treatment to ensure unbiased allocation.

• Selection and Exclusion Criteria

Inclusion criteria

Age ≥ 20 years. Diagnosed with Stage III Periodontitis (Grade B or C) according to the 2017 AAP/EFP classification.

Minimum of 16 natural teeth (excluding third molars and teeth indicated for extraction); at least 6 sites with Probing Pocket Depth (PPD) and Clinical Attachment Loss (CAL) ≥5mm, with bleeding on probing.

No periodontal treatment in the last 3 months; non-smokers

Exclusion criteria

Systemic conditions: Mental illness, HIV, autoimmune diseases, chronic hematological, renal, or respiratory diseases, Type 2 diabetes, or obesity.

Pregnancy or breastfeeding. Current use of ≥1g Omega-3/day or anticoagulants (Warfarin, Clopidogrel). History of gastrointestinal bleeding or peptic ulcers; allergy/hypersensitivity to Aspirin or Omega-3.

• Intervention Procedures

All participants receive standard non-surgical periodontal therapy, followed by a 30-day supplement regimen:

Non-Surgical Periodontal Treatment (All Groups):

Full-mouth ultrasonic scaling and deep root planing using Gracey curettes. Subgingival irrigation with 0.12% Chlorhexidine. Polishing and oral hygiene instructions (modified Bass technique and interdental cleaning).

Group-Specific Regimens:

Control Group: SRP only (no medicinal supplements). Intervention Group 1: SRP + Omega-3 (Now Foods, 300mg per capsule). Dosage: 4 capsules/day (2 in the morning, 2 in the evening after meals).

Intervention Group 2: SRP + Omega-3 (4 capsules/day) + Aspirin 81mg (Agimexpharm). Dosage: 1 Aspirin tablet/day after breakfast.

• Follow-up and Outcome Measures The study includes a long-term follow-up period of 24 months. Participants will return for re-examination at T1 (3 months), T2 (6 months), T3 (12 months), and T4 (24 months).

Clinical Parameters: At each visit, researchers will measure Probing Pocket Depth (PPD), Clinical Attachment Loss (CAL), Full-mouth Plaque Score (FMPS%), Bleeding on Probing (BOP%), and Gingival Index (GI).

Biochemical Evaluation: Venous blood samples will be collected at each time point to quantify serum levels of IL-6 and CRP.

Laboratory Analysis: Serum is separated via centrifugation and stored at -80 °C. IL-6 levels are measured using the Cobas E601 analyzer (electrochemiluminescence immunoassay) at the 108 Military Central Hospital.

Inclusion criteria

Age ≥ 20 years. Diagnosed with Stage III Periodontitis (Grade B or C) according to the 2017 AAP/EFP classification.

Minimum of 16 natural teeth (excluding third molars and teeth indicated for extraction); at least 6 sites with Probing Pocket Depth (PPD) and Clinical Attachment Loss (CAL) ≥5mm, with bleeding on probing.

No periodontal treatment in the last 3 months; non-smokers

Exclusion criteria

Systemic conditions: Mental illness, HIV, autoimmune diseases, chronic hematological, renal, or respiratory diseases, Type 2 diabetes, or obesity.

Pregnancy or breastfeeding. Current use of ≥1g Omega-3/day or anticoagulants (Warfarin, Clopidogrel). History of gastrointestinal bleeding or peptic ulcers; allergy/hypersensitivity to Aspirin or Omega-3.