PeriodontitisNCT07385300
Omega-3 Pufa and Aspirin as Adjunctive Therapy in Treatment of Smoker Patients With Stage Iii Periodontitis
A study testing Omega-3 PUFA and Aspirin as adjunctive therapy to (SRP), Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP) and scaling and root planning (SRP) in people with Periodontitis and Diabete Mellitus, run by Alexandria University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Periodontitis, Diabete Mellitus
- What is being tested?
- Omega-3 PUFA and Aspirin as adjunctive therapy to (SRP), Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP) and scaling and root planning (SRP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2023to 22 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
About this study
Official 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)
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.
- Conditions
- Periodontitis, Diabete Mellitus
- Being tested
- Omega-3 PUFA and Aspirin as adjunctive therapy to (SRP), Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP), scaling and root planning (SRP)
- Medical subject headings
- Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 PUFA and Aspirin | Experimental | Not described Receives: Other: Omega-3 PUFA and Aspirin as adjunctive therapy to (SRP) |
| Omega-3 PUFA and Aspirin and doxycycline | Experimental | Not described Receives: Other: Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP) |
| Conventional | Active comparator | Not described Receives: Other: scaling and root planning (SRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in probing depth
the distance (in millimeters) from the gingival margin to the base of the gingival sulcus or periodontal pocket.
Measured: baseline (t0) and at 3 (t1) and 6 months (t2)
change in clinical attachment level
the distance (in millimeters) from the cemento-enamel junction (CEJ) to the base of the periodontal pocket.
Measured: baseline (t0) and at 3 (t1) and 6 months (t2)
Secondary outcomes (2)
change in gingival index
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)
Measured: baseline (t0) and at 3 (t1) and 6 months (t2)
change in bleeding on probing
presence of bleeding from the gingival sulcus or periodontal pocket within ~10 seconds after gentle probing.
Measured: baseline (t0) and at 3 (t1) and 6 months (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start20 Aug 2023
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385300
- Sponsor's protocol ID
- 0710-06/2023
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07385300
- Acronym / sponsor ID
- 0710-06/2023
- Conditions
- Periodontitis, Diabete Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 4 Feb 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omega-3 PUFA and Aspirin | Experimental | Other: Omega-3 PUFA and Aspirin as adjunctive therapy to (SRP) |
| Omega-3 PUFA and Aspirin and doxycycline | Experimental | Other: Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP) |
| Conventional | Active comparator | Other: scaling and root planning (SRP) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 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) | Other | Omega-3 PUFA and Aspirin |
| 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) | Other | Omega-3 PUFA and Aspirin and doxycycline |
| scaling and root planning (SRP)fifteen patients will receive periodontal debridement (CG) | Other | Conventional |
Primary outcome
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.
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.
2 secondary outcomes
change in gingival index
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 PUFA and Aspirin as adjunctive therapy to (SRP), Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP) and scaling and root planning (SRP) in people with Periodontitis and Diabete Mellitus, run by Alexandria 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 4 Feb 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in probing depth (time frame: baseline (t0) and at 3 (t1) and 6 months (t2)). The study lists 2 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 4 Feb 2026.