Omega-3 Plus Low-Dose Aspirin in Smokers With Stage III Periodontitis (OASP)

June 23, 2026 updated by: Alaa hesham Mahmoud, Al-Azhar University

Clinical and Biochemical Evaluation of the Effect of Omega-3 Fatty Acids Plus Low-Dose Aspirin as an Adjunct to Non-Surgical Periodontal Therapy in Smoker Patients With Stage III Periodontitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial

This randomized double-blind placebo-controlled clinical trial aims to evaluate the clinical and biochemical effects of omega-3 fatty acids combined with low-dose aspirin as an adjunct to scaling and root planing (SRP) in smoker patients with Stage III periodontitis. The study compares test and control groups regarding periodontal clinical parameters and gingival crevicular fluid interleukin-1 beta (IL-1β) levels Or other inflammatory markers that will be determined later at baseline, 3 months, and 6 months following treatment

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

characterized by progressive destruction of the supporting structures of the teeth. Smoking is a major risk factor that increases disease severity and impairs periodontal healing. Host modulation therapy using omega-3 fatty acids and low-dose aspirin has been suggested as a promising adjunctive approach to conventional periodontal treatment due to its anti-inflammatory and pro-resolving effects.

This study is a randomized, double-blind, placebo-controlled clinical trial conducted on smoker patients diagnosed with Stage III periodontitis. Participants are allocated into two groups. The test group receives scaling and root planing (SRP) followed by omega-3 fatty acids and low-dose aspirin, while the control group receives SRP and placebo.

Clinical periodontal parameters including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL) are assessed at baseline, 3 months, and 6 months. Gingival crevicular fluid samples are collected for biochemical assessment of interleukin-1 beta (IL-1β) levels using ELISA Or other inflammatory markers that will be determined later.

The primary objective is to evaluate changes in probing pocket depth and clinical attachment level. Secondary outcomes include changes in inflammatory biomarker levels and other periodontal clinical parameters. The findings may provide evidence regarding the efficacy of omega-3 fatty acids and low-dose aspirin as adjunctive host modulation therapy in smoker patients with Stage III periodontitis.

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11651
        • Recruiting
        • Faculty of Dental Medicine for Girls, Al-Azhar University
        • Contact:
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - Male or female smokers aged 30 to 50 years.
  • Diagnosed with Stage III periodontitis according to the 2017 World Workshop classification.
  • Probing pocket depth (PPD) ≥ 5 mm.
  • Clinical attachment loss (CAL) ≥ 5 mm.
  • Presence of at least 20 natural teeth.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • - Systemic diseases affecting periodontal health.
  • Pregnancy or lactation.
  • Periodontal treatment within the previous 6 months.
  • Use of antibiotics or anti-inflammatory drugs within the previous 6 months.
  • Allergy or hypersensitivity to omega-3 fatty acids or aspirin.
  • Long-term anticoagulant therapy.
  • History of gastric ulcer or bleeding disorders.
  • Participation in another clinical trial within the previous 3 month

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3 Plus Low-Dose Aspirin
Participants receive scaling and root planing followed by omega-3 fatty acids (EPA 640 mg and DHA 480 mg daily) plus low-dose aspirin (75 mg daily) for 6 months.
Drug: Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin
Matching placebo capsules administered orally once daily for 6 months following scaling and root planing.
Other Names:
  • placebo
Placebo Comparator: Placebo Control
Participants receive scaling and root planing followed by placebo capsules for 6 months.
Drug: Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin
Matching placebo capsules administered orally once daily for 6 months following scaling and root planing.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Pocket Depth (PPD)
Time Frame: Baseline, 3 Months, and 6 Months
Mean change in probing pocket depth measured in millimeters at six sites per tooth.
Baseline, 3 Months, and 6 Months
Change in Probing Pocket Depth (PPD)
Time Frame: Baseline, 3 Months, and 6 Months
Mean reduction in periodontal probing pocket depth measured in millimeters at six sites per tooth.
Baseline, 3 Months, and 6 Months
Change in Clinical Attachment Level (CAL)
Time Frame: Baseline, 3 Months, and 6 Months
Mean gain in clinical attachment level measured in millimeters.
Baseline, 3 Months, and 6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Interleukin-1 Beta (IL-1β) Levels
Time Frame: Baseline, 3 Months, and 6 Months
Changes in gingival crevicular fluid IL-1β levels assessed using ELISA.
Baseline, 3 Months, and 6 Months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: naglaa M EL wakeel, professor, Faculty of Dental Medicine for Girls, Al-Azhar University

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)

January 15, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMPDR-105-1u

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study includes identifiable clinical and laboratory data collected for academic research purposes only.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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