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NCT Number: NCT07385300

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

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.

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Key information

Conditions

Periodontitis Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Stomatognathic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Omega-3 PUFA and Aspirin as adjunctive therapy to (SRP)

Other

fifteen patients will receive ω-3 PUFA + ASA (1g of fish oil/day + 75mg ASA/day for 2 months) after periodontal debridement (TG1)

Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP)

Other

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)

scaling and root planning (SRP)

Other

fifteen patients will receive periodontal debridement (CG)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2026
Registry last updated
Feb 4, 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.

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