Periodontal DiseaseOASPNCT07673185
Omega-3 Plus Low-Dose Aspirin in Smokers With Stage III Periodontitis
A study testing Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin in people with Periodontal Disease and Periodontitis (Stage 3), run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Periodontal Disease, Periodontitis (Stage 3), Smoking Behaviors
- What is being tested?
- Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - 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.
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, 11651
Alaa H mahmoud, BDS, MSc Candidate, +201146816128 ext. +2, alaahesham419@gmail.com
ALAA hesham mah,oud, BDS, MSc Candidate, +201146816128 ext. +2, alaahesham419@gmail.com
About this study
Official 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
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
Read the 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.
- Being tested
- Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin, Placebo
- Keywords
- omega 3, smoker, stage 3
- Medical subject headings
- Periodontal Diseases, Periodontitis, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirinDrug
participants receive omega3 fatty acid (EPA640+DHA480) plus low dose aspirin (75mg) orally once for 6 months following scaling and root planning
PlaceboDrug
matching placebo capsules administered orally once daily for 6 months following scaling and root planning
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
Mean change in probing pocket depth measured in millimeters at six sites per tooth.
Measured: 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.
Measured: Baseline, 3 Months, and 6 Months
Change in Clinical Attachment Level (CAL)
Mean gain in clinical attachment level measured in millimeters.
Measured: Baseline, 3 Months, and 6 Months
Secondary outcomes (1)
Change in Interleukin-1 Beta (IL-1β) Levels
Changes in gingival crevicular fluid IL-1β levels assessed using ELISA.
Measured: Baseline, 3 Months, and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start15 Jan 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa hesham Mahmoud, Al-Azhar University
- Investigators
- naglaa M EL wakeel, professor, Principal investigator, Faculty of Dental Medicine for Girls, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673185
- Sponsor's protocol ID
- OMPDR-105-1u
- Acronym
- OASP
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes identifiable clinical and laboratory data collected for academic research purposes only.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07673185
- Acronym / sponsor ID
- OASP / OMPDR-105-1u
- Keywords
- omega 3, smoker, stage 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Plus Low-Dose Aspirin | Experimental | Drug: Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirinParticipants 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. |
| Placebo Control | Placebo comparator | Drug: PlaceboParticipants receive scaling and root planing followed by placebo capsules for 6 months. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- - 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.
Key exclusion criteria (8 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirinparticipants receive omega3 fatty acid (EPA640+DHA480) plus low dose aspirin (75mg) orally once for 6 months following scaling and root planning | Drug | Omega-3 Plus Low-Dose Aspirin |
| Placebomatching placebo capsules administered orally once daily for 6 months following scaling and root planning | Drug | Placebo Control |
Primary outcome
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.
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.
Change in Clinical Attachment Level (CAL)
Time frame: Baseline, 3 Months, and 6 Months
Mean gain in clinical attachment level measured in millimeters.
1 secondary outcome
Change in Interleukin-1 Beta (IL-1β) Levels
Time frame: Baseline, 3 Months, and 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes identifiable clinical and laboratory data collected for academic research purposes only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
naglaa M EL wakeel, professor principal investigator
Faculty of Dental Medicine for Girls, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin in people with Periodontal Disease and Periodontitis (Stage 3), run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALAA hesham mah,oud, BDS, MSc Candidate (+201146816128 ext. +2, alaahesham419@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) (time frame: Baseline, 3 Months, and 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.