Omega-3 Pufa and Aspirin as Adjunctive Therapy in Treatment of Smoker Patients With Stage Iii Periodontitis

January 27, 2026 updated by: Alexandria University

Evaluation of the Use of Omega-3 Pufa and Aspirin as Adjunctive Therapy in the Treatment of Smoker Patients With Stage Iii Periodontitis (Randomized Clinical Trial)

Background: Smoking reduces the effect of non-surgical periodontal therapy, a host modulation regimen consisting of omega-3 polyunsaturated fatty acids (ω-3 PUFA) supplementation with low-dose aspirin (ASA) with or without systemic doxycycline has been proposed to improve treatment response.

The Aim of the study is to explore the clinical effects of orally administered omega-3 PUFA and ASA with or without systemic doxycycline with periodontal debridement in treatment of smoker individuals with stage III periodontitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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

  • Egypt
      • Alexandria, Egypt
        • Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Smoker patients who smoke ≥ 10 cigarettes per day.
  • Stages III, Grades C periodontitis with at least one site with PD≥6 and CAL ≥5 mm.

Exclusion Criteria:

  • Scaling and root planning in the previous 6 months(that may confound the effect of treatment)
  • Antimicrobial therapy in the previous 6 months(that may confound the effect of treatment)
  • Chronic systemic diseases that may have an impact on periodontitis progression (diabetes mellitus).
  • Systemic diseases that may contraindicate aspirin or doxycycline taking (kidney and liver diseases)
  • Allergy to doxycycline
  • Long-term usage of medications that may impair periodontal health
  • Allergy to fish/seafood

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: Conventional
Other: scaling and root planning (SRP)
fifteen patients will receive periodontal debridement (CG)
Experimental: Omega-3 PUFA and Aspirin
Other: Omega-3 PUFA and Aspirin as adjunctive therapy to (SRP)
fifteen patients will receive ω-3 PUFA + ASA (1g of fish oil/day + 75mg ASA/day for 2 months) after periodontal debridement (TG1)
Experimental: Omega-3 PUFA and Aspirin and doxycycline
Other: Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP)
fifteen patients will receive ω-3 PUFA + ASA (1g of fish oil/day + 75mg ASA/day for 2 months) and oral dosage of doxycycline (100mg every 12 hours on day 1, then 100 mg once daily for 6 days) after periodontal debridement (TG2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in probing depth
Time Frame: baseline (t0) and at 3 (t1) and 6 months (t2)
the distance (in millimeters) from the gingival margin to the base of the gingival sulcus or periodontal pocket.
baseline (t0) and at 3 (t1) and 6 months (t2)
change in clinical attachment level
Time Frame: baseline (t0) and at 3 (t1) and 6 months (t2)
the distance (in millimeters) from the cemento-enamel junction (CEJ) to the base of the periodontal pocket.
baseline (t0) and at 3 (t1) and 6 months (t2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in gingival index
Time Frame: baseline (t0) and at 3 (t1) and 6 months (t2)
score 0: Normal gingiva (pink, firm, no bleeding) score 1: Mild inflammation (Slight color change, Slight edema, No bleeding on probing) score 2:Moderate inflammation (Redness, edema, glazing, Bleeding on probing present) score 3: Severe inflammation (Marked redness and edema, Ulceration, Spontaneous bleeding)
baseline (t0) and at 3 (t1) and 6 months (t2)
change in bleeding on probing
Time Frame: baseline (t0) and at 3 (t1) and 6 months (t2)
presence of bleeding from the gingival sulcus or periodontal pocket within ~10 seconds after gentle probing.
baseline (t0) and at 3 (t1) and 6 months (t2)

Collaborators and Investigators

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

Sponsor

Alexandria 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)

August 20, 2023

Primary Completion (Actual)

August 22, 2024

Study Completion (Actual)

August 22, 2024

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0710-06/2023

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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