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

NCT07673185 | Recruiting

• 1 other identifier: OMPDR-105-1u
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontal Disease; Periodontitis (Stage 3); Smoking Behaviors

Keywords

omega 3; smoker; stage 3

Outcome Measures

Primary Outcomes (3)

• Change in Probing Pocket Depth (PPD)

  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)

  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)

  Mean gain in clinical attachment level measured in millimeters.

  Baseline, 3 Months, and 6 Months

Secondary Outcomes (1)

• Change in Interleukin-1 Beta (IL-1β) Levels

  Baseline, 3 Months, and 6 Months

Study Arms (2)

Omega-3 Plus Low-Dose Aspirin

EXPERIMENTAL

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

Placebo Control

PLACEBO COMPARATOR

Participants receive scaling and root planing followed by placebo capsules for 6 months.

Drug: Placebo

Interventions

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

Omega-3 Plus Low-Dose Aspirin

Placebo DRUG

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

Placebo Control

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, 11651, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Smoking

Interventions

Fatty Acids, Omega-3; Aspirin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• naglaa M EL wakeel, professor

  Faculty of Dental Medicine for Girls, Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ALAA hesham mah,oud, BDS, MSc Candidate

CONTACT

+201146816128; alaahesham419@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind placebo-controlled study. Participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Degree Candidate, Department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology

Model Details: This is a randomized double-blind placebo-controlled clinical trial. Participants, care providers, investigators, and outcome assessors are blinded to treatment allocation. The test group receives omega-3 fatty acids plus low-dose aspirin following scaling and root planing, while the control group receives placebo following scaling and root planing.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: January 15, 2025
• Primary Completion: July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)