Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07673185

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Periodontal Disease Behavior Mouth Diseases Periodontal Diseases Periodontitis Periodontitis (Stage 3) Smoking Smoking Behaviors Stomatognathic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin

Drug

participants receive omega3 fatty acid (EPA640+DHA480) plus low dose aspirin (75mg) orally once for 6 months following scaling and root planning

Placebo

Drug

matching placebo capsules administered orally once daily for 6 months following scaling and root planning

Primary outcomes

  1. 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.

  2. 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.

  3. Change in Clinical Attachment Level (CAL)

    Time frame: Baseline, 3 Months, and 6 Months

    Mean gain in clinical attachment level measured in millimeters.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ALAA hesham mah,oud, BDS, MSc Candidate

CONTACT

[email protected]

+201146816128 ext. +2

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: OASP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.