Non-surgical Periodontitis Treatment With Aspirin and Omega-3

April 11, 2026 updated by: Nguyen Ngoc Hoa, Hanoi Medical University

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Hanoi
      • Hanoi, Hanoi, Vietnam, 11600
        • Department of Stomatology, 108 Military Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SRP only
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).
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.
Experimental: SRP + Omega-3
SRP + Omega-3 (Now Foods, 300mg per capsule). Dosage: 4 capsules/day (2 in the morning, 2 in the evening after meals).
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.
Experimental: SRP + Omega-3 + Aspirin
SRP + Omega-3 (4 capsules/day) + Aspirin 81mg (Agimexpharm). Dosage: 1 Aspirin tablet/day after breakfast.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Pocket Depth (PPD)
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months
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.
Baseline, 3 months, 6 months, 12 months, and 24 months
Serum Interleukin-6 (IL-6) Concentration
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months
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.
Baseline, 3 months, 6 months, 12 months, and 24 months
Serum C-Reactive Protein (CRP) Concentration
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months
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.
Baseline, 3 months, 6 months, 12 months, and 24 months
Modified Gingival Index (MGI)
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months
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.
Baseline, 3 months, 6 months, 12 months, and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full-mouth Bleeding on Probing (BOP) Percentage
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months
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.
Baseline, 3 months, 6 months, 12 months, and 24 months
Clinical Attachment Loss (CAL)
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months
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.
Baseline, 3 months, 6 months, 12 months, and 24 months
Full-mouth Plaque Score (FMPS)
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months
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.
Baseline, 3 months, 6 months, 12 months, and 24 months
Lactate Dehydrogenase (LDH) Levels
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months
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.
Baseline, 3 months, 6 months, 12 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanoi Medical University

Investigators

  • Study Director: Nguyen Ngoc Hoa, PhD, School of Dentistry, Hanoi Medical University, Vietnam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1223/HĐĐĐ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis

Clinical Trials on Scaling and Root Planing (SRP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe