NCT07523841

Non-surgical Periodontitis Treatment With Aspirin and Omega-3

The Efficacy of Non-surgical Periodontal Therapy in Combination With Aspirin and Omega-3 Fatty Acids.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hanoi Medical University · Academic / Other
• Sex: All
• Age: 20 Days
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Periodontitis
• Periodontitis (Stage 3)

Interventions

Type	Name	Description
PROCEDURE	Scaling and Root Planing (SRP)	Full-mouth ultrasonic scaling and deep root planing using Gracey curettes, followed by subgingival irrigation with 0.12% Chlorhexidine.
DIETARY_SUPPLEMENT	Omega-3 Fatty Acids	Omega-3 (300mg per capsule: 180mg EPA/120mg DHA). Dosage: 4 capsules/day for 30 days.
DRUG	Low-dose aspirin	81mg Aspirin (Agimexpharm). Dosage: 1 tablet/day for 30 days.

Timeline

• Start date: 2023-04-01
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2026-04-13
• Last updated: 2026-04-15

Locations

1 site across 1 country: Vietnam