The goal of this clinical trial is to learn if non-surgical periodontal treatment combined with Omega-3 fatty acids and Aspirin can improve clinical outcomes and biochemical markers in patients with periodontitis. The main questions it aims to answer are: Does the combination of Omega-3 and low-dose Aspirin significantly change the concentration of biochemical and immunological markers such as Interleukin-6 (IL-6) and C-reactive protein (CRP) in serum? Is the combination of Omega-3 and Aspirin more effective than Omega-3 alone or standard non-surgical treatment in treating periodontitis? Researchers will compare three groups: Control group: Scaling and root planing (SRP) only. Intervention group 1: SRP combined with Omega-3 fatty acids. Intervention group 2: SRP combined with Omega-3 fatty acids and 81mg Aspirin. The comparison aims to see if the combined therapy (Intervention group 2) provides superior anti-inflammatory effects and better clinical healing compared to the other groups. Participants will: Undergo clinical screening and selection based on study criteria. Be randomly assigned to one of the three treatment arms. Receive non-surgical periodontal treatment (scaling and root planing). Take prescribed supplements (Omega-3 or Omega-3 combined with 81mg Aspirin) according to their assigned group. Provide blood samples to measure changes in biochemical markers (IL-6, CRP).
1. 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. 2. 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. 3. 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. 4. 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. 5. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Full-mouth ultrasonic scaling and deep root planing using Gracey curettes, followed by subgingival irrigation with 0.12% Chlorhexidine.
Omega-3 (300mg per capsule: 180mg EPA/120mg DHA). Dosage: 4 capsules/day for 30 days.
81mg Aspirin (Agimexpharm). Dosage: 1 tablet/day for 30 days.
Department of Stomatology, 108 Military Central Hospital
Hanoi, Hanoi, Vietnam
Probing Pocket Depth (PPD)
Measured as the distance from the gingival margin to the bottom of the periodontal pocket using a William's periodontal probe. Values are reported in millimeters (mm). Higher values indicate deeper pockets and greater periodontal disease severity.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Serum Interleukin-6 (IL-6) Concentration
Quantification of serum IL-6 levels using the electrochemiluminescence immunoassay (ECLIA) to evaluate systemic anti-inflammatory effects. Values are reported in picograms per milliliter (pg/mL). Higher values indicate higher levels of systemic inflammation.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Serum C-Reactive Protein (CRP) Concentration
Quantitative assessment of high-sensitivity CRP in serum to monitor the systemic inflammatory response. Values are reported in milligrams per liter (mg/L). Higher values indicate a more significant systemic inflammatory response.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Modified Gingival Index (MGI)
Assessment of the severity of gingival inflammation using the Modified Gingival Index (MGI) by Lobene. This is a non-invasive index based on visual inspection of the gingiva. The scale for each site ranges from 0 to 4 (0 = Absence of inflammation; 1 = Mild inflammation in any portion of the gingival unit; 2 = Mild inflammation in the entire gingival unit; 3 = Moderate inflammation; 4 = Severe inflammation). The outcome is reported as the mean score of all sites. Total scores range from 0 to 4, where higher scores indicate greater severity of gingival inflammation.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Full-mouth Bleeding on Probing (BOP) Percentage
The percentage of sites exhibiting bleeding within 30 seconds after gentle probing. Values range from 0% to 100%. Higher percentages indicate more widespread gingival inflammation and poorer periodontal health.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Clinical Attachment Loss (CAL)
Measured as the distance from the cemento-enamel junction (CEJ) to the bottom of the periodontal pocket. Values are reported in millimeters (mm). Higher values indicate greater loss of periodontal attachment and increased disease severity.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Full-mouth Plaque Score (FMPS)
The percentage of tooth surfaces where plaque is present. All teeth are examined at 4 or 6 sites per tooth. The score is calculated as the number of surfaces with plaque divided by the total number of surfaces examined, multiplied by 100. Values range from 0% to 100%, where higher percentages indicate poorer oral hygiene and greater plaque accumulation.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Lactate Dehydrogenase (LDH) Levels
Quantification of LDH activity in serum as a biomarker for cell death and tissue degradation. Values are reported in Units per Liter (U/L). Higher values indicate increased cell death or tissue damage.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
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