PeriodontitisNCT07523841

Non-surgical Periodontitis Treatment With Aspirin and Omega-3

A study testing Scaling and Root Planing (SRP), Omega-3 Fatty Acids and Low-dose aspirin in people with Periodontitis and Periodontitis (Stage 3), run by Hanoi Medical University at 1 site in Vietnam.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The goal of this clinical trial is to learn if non-surgical periodontal treatment combined with Omega-3 fatty acids and Aspirin can improve clinical outcomes and biochemical markers in patients with periodontitis. Read more about this study

Who is it for?: Ages 20 days and older
Conditions the study is for: Periodontitis, Periodontitis (Stage 3)
What is being tested?: Scaling and Root Planing (SRP), Omega-3 Fatty Acids and Low-dose aspirin
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteVietnam
Study dates: 1 Apr 2023to 1 May 2027
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 20 days and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age ≥ 20 years. Diagnosed with Stage III Periodontitis (Grade B or C) according to the 2017 AAP/EFP classification.
Minimum of 16 natural teeth (excluding third molars and teeth indicated for extraction); at least 6 sites with Probing Pocket Depth (PPD) and Clinical Attachment Loss (CAL) ≥5mm, with bleeding on probing.
No periodontal treatment in the last 3 months; non-smokers

Who cannot join

Systemic conditions: Mental illness, HIV, autoimmune diseases, chronic hematological, renal, or respiratory diseases, Type 2 diabetes, or obesity.
Pregnancy or breastfeeding. Current use of ≥1g Omega-3/day or anticoagulants (Warfarin, Clopidogrel). History of gastrointestinal bleeding or peptic ulcers; allergy/hypersensitivity to Aspirin or Omega-3.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

Department of Stomatology, 108 Military Central Hospital
Hanoi, Hanoi, 11600

Other trials in Vietnam

About this study

Official title: The Efficacy of Non-surgical Periodontal Therapy in Combination With Aspirin and Omega-3 Fatty Acids.

Does the combination of Omega-3 and low-dose Aspirin significantly change the concentration of biochemical and immunological markers such as Interleukin-6 (IL-6) and C-reactive protein (CRP) in serum?

Is the combination of Omega-3 and Aspirin more effective than Omega-3 alone or standard non-surgical treatment in treating periodontitis?

Researchers will compare three groups:

Control group: Scaling and root planing (SRP) only.

Intervention group 1: SRP combined with Omega-3 fatty acids.

Intervention group 2: SRP combined with Omega-3 fatty acids and 81mg Aspirin.

The comparison aims to see if the combined therapy (Intervention group 2) provides superior anti-inflammatory effects and better clinical healing compared to the other groups.

Participants will:

Undergo clinical screening and selection based on study criteria.

Be randomly assigned to one of the three treatment arms.

Receive non-surgical periodontal treatment (scaling and root planing).

Take prescribed supplements (Omega-3 or Omega-3 combined with 81mg Aspirin) according to their assigned group.

Provide blood samples to measure changes in biochemical markers (IL-6, CRP).

Read the detailed description

Rationale Periodontitis is a chronic inflammatory disease caused by the host's immune response to pathogenic microorganisms, leading to clinical attachment loss and alveolar bone destruction. While non-surgical periodontal therapy (Scaling and Root Planing - SRP) is the gold standard, some patients experience disease progression due to residual subgingival biofilms. This study explores Host Modulation Therapy (HMT) as an adjunct to SRP. The combination of Omega-3 fatty acids and low-dose Aspirin (81mg) is hypothesized to enhance the resolution of inflammation. Omega-3 serves as a substrate for pro-resolving mediators (Resolvins, Protectins, Maresins), while Aspirin triggers the synthesis of Aspirin-triggered Lipoxins via the COX-2 pathway. This synergistic approach aims to reduce systemic pro-inflammatory markers, specifically Interleukin-6 (IL-6) and C-reactive protein (CRP), and improve clinical healing.
Detailed Study Design This is a randomized controlled clinical trial involving 120 participants. Randomization: Participants who meet the inclusion criteria are randomly assigned to one of three groups (1:1:1 ratio). Randomization is performed using Excel software (RAND function) to generate a random sequence. Allocation Concealment: Group assignments are placed in sealed, opaque envelopes and managed by a researcher not directly involved in the clinical treatment to ensure unbiased allocation.
Selection and Exclusion Criteria Inclusion Criteria: Age ≥ 20 years. Diagnosed with Stage III Periodontitis (Grade B or C) according to the 2017 AAP/EFP classification. Minimum of 16 natural teeth (excluding third molars and teeth indicated for extraction); at least 6 sites with Probing Pocket Depth (PPD) and Clinical Attachment Loss (CAL) ≥5mm, with bleeding on probing. No periodontal treatment in the last 3 months; non-smokers Exclusion Criteria: Systemic conditions: Mental illness, HIV, autoimmune diseases, chronic hematological, renal, or respiratory diseases, Type 2 diabetes, or obesity. Pregnancy or breastfeeding. Current use of ≥1g Omega-3/day or anticoagulants (Warfarin, Clopidogrel). History of gastrointestinal bleeding or peptic ulcers; allergy/hypersensitivity to Aspirin or Omega-3.
Intervention Procedures All participants receive standard non-surgical periodontal therapy, followed by a 30-day supplement regimen: Non-Surgical Periodontal Treatment (All Groups): Full-mouth ultrasonic scaling and deep root planing using Gracey curettes. Subgingival irrigation with 0.12% Chlorhexidine. Polishing and oral hygiene instructions (modified Bass technique and interdental cleaning). Group-Specific Regimens: Control Group: SRP only (no medicinal supplements). Intervention Group 1: SRP + Omega-3 (Now Foods, 300mg per capsule). Dosage: 4 capsules/day (2 in the morning, 2 in the evening after meals). Intervention Group 2: SRP + Omega-3 (4 capsules/day) + Aspirin 81mg (Agimexpharm). Dosage: 1 Aspirin tablet/day after breakfast.
Follow-up and Outcome Measures The study includes a long-term follow-up period of 24 months. Participants will return for re-examination at T1 (3 months), T2 (6 months), T3 (12 months), and T4 (24 months).

Clinical Parameters: At each visit, researchers will measure Probing Pocket Depth (PPD), Clinical Attachment Loss (CAL), Full-mouth Plaque Score (FMPS%), Bleeding on Probing (BOP%), and Gingival Index (GI).

Biochemical Evaluation: Venous blood samples will be collected at each time point to quantify serum levels of IL-6 and CRP.

Laboratory Analysis: Serum is separated via centrifugation and stored at -80 °C. IL-6 levels are measured using the Cobas E601 analyzer (electrochemiluminescence immunoassay) at the 108 Military Central Hospital.

Conditions: Periodontitis, Periodontitis (Stage 3)
Being tested: Scaling and Root Planing (SRP), Omega-3 Fatty Acids, Low-dose aspirin
Keywords: Periodontitis, Host Modulation Therapy, Non-surgical Periodontal Therapy, Omega-3 fatty acids, low-dose Aspirin
Medical subject headings: Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Scaling and Root Planing (SRP)Procedure or surgery
Full-mouth ultrasonic scaling and deep root planing using Gracey curettes, followed by subgingival irrigation with 0.12% Chlorhexidine.
Omega-3 Fatty AcidsDietary supplement
Omega-3 (300mg per capsule: 180mg EPA/120mg DHA). Dosage: 4 capsules/day for 30 days.
Low-dose aspirinDrug
81mg Aspirin (Agimexpharm). Dosage: 1 tablet/day for 30 days.

Study groups in NCT07523841
Study group	Role	What they receive
SRP only	Active comparator	Full-mouth ultrasonic scaling and deep root planing using Gracey curettes. Subgingival irrigation with 0.12% Chlorhexidine. Polishing and oral hygiene instructions (modified Bass technique and interdental cleaning). Receives: Procedure: Scaling and Root Planing (SRP)
SRP + Omega-3	Experimental	SRP + Omega-3 (Now Foods, 300mg per capsule). Dosage: 4 capsules/day (2 in the morning, 2 in the evening after meals). Receives: Procedure: Scaling and Root Planing (SRP); Dietary Supplement: Omega-3 Fatty Acids
SRP + Omega-3 + Aspirin	Experimental	SRP + Omega-3 (4 capsules/day) + Aspirin 81mg (Agimexpharm). Dosage: 1 Aspirin tablet/day after breakfast. Receives: Procedure: Scaling and Root Planing (SRP); Dietary Supplement: Omega-3 Fatty Acids; Drug: Low-dose aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

Probing Pocket Depth (PPD)
Measured as the distance from the gingival margin to the bottom of the periodontal pocket using a William's periodontal probe. Values are reported in millimeters (mm). Higher values indicate deeper pockets and greater periodontal disease severity.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months
Serum Interleukin-6 (IL-6) Concentration
Quantification of serum IL-6 levels using the electrochemiluminescence immunoassay (ECLIA) to evaluate systemic anti-inflammatory effects. Values are reported in picograms per milliliter (pg/mL). Higher values indicate higher levels of systemic inflammation.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months
Serum C-Reactive Protein (CRP) Concentration
Quantitative assessment of high-sensitivity CRP in serum to monitor the systemic inflammatory response. Values are reported in milligrams per liter (mg/L). Higher values indicate a more significant systemic inflammatory response.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months
Modified Gingival Index (MGI)
Assessment of the severity of gingival inflammation using the Modified Gingival Index (MGI) by Lobene. This is a non-invasive index based on visual inspection of the gingiva. The scale for each site ranges from 0 to 4 (0 = Absence of inflammation; 1 = Mild inflammation in any portion of the gingival unit; 2 = Mild inflammation in the entire gingival unit; 3 = Moderate inflammation; 4 = Severe inflammation). The outcome is reported as the mean score of all sites. Total scores range from 0 to 4, where higher scores indicate greater severity of gingival inflammation.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months

Secondary outcomes (4)

Full-mouth Bleeding on Probing (BOP) Percentage
The percentage of sites exhibiting bleeding within 30 seconds after gentle probing. Values range from 0% to 100%. Higher percentages indicate more widespread gingival inflammation and poorer periodontal health.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months
Clinical Attachment Loss (CAL)
Measured as the distance from the cemento-enamel junction (CEJ) to the bottom of the periodontal pocket. Values are reported in millimeters (mm). Higher values indicate greater loss of periodontal attachment and increased disease severity.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months
Full-mouth Plaque Score (FMPS)
The percentage of tooth surfaces where plaque is present. All teeth are examined at 4 or 6 sites per tooth. The score is calculated as the number of surfaces with plaque divided by the total number of surfaces examined, multiplied by 100. Values range from 0% to 100%, where higher percentages indicate poorer oral hygiene and greater plaque accumulation.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months
Lactate Dehydrogenase (LDH) Levels
Quantification of LDH activity in serum as a biomarker for cell death and tissue degradation. Values are reported in Units per Liter (U/L). Higher values indicate increased cell death or tissue damage.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20231 May 2027

First posted13 Apr 2026
Study start1 Apr 2023
Primary completion1 Apr 2027 (estimated)
Study completion1 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for PeriodontitisStudies of the same condition, open and under way.
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 study is designed as a triple-arm, parallel-group randomized controlled trial with a 1:1:1 allocation ratio. The study employs an assessor-blind (single-blind) masking approach to ensure the objectivity of the results. Key features of the study model include: * Blinding/Masking: The clinical examiners responsible for measuring periodontal parameters (PPD, CAL, FMPS, BOP, GI) and the laboratory technicians performing the biochemical assays (IL-6, CRP) are kept blinded to the treatment group assignments of all participants. * Allocation: After the initial screening and baseline data collection, participants are assigned to one of three groups: Control (SRP only), Intervention 1 (SRP + Omega-3), or Intervention 2 (SRP + Omega-3 + Aspirin). * Longitudinal Assessment: The model follows a longitudinal design with evaluations at baseline and four subsequent follow-up points (3, 6, 12, and 24 months post-intervention). This structure allows for the assessment of both the immediate anti-in
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07523841
Sponsor's protocol ID: 1223/HĐĐĐ
Status last verified: Apr 2026
First submitted: 5 Apr 2026
Last updated: 15 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Montero E, Lopez M, Vidal H, Martinez M, Virto L, Marrero J, Herrera D, Zapatero A, Sanz M. Impact of periodontal therapy on systemic markers of inflammation in patients with metabolic syndrome: A randomized clinical trial. Diabetes Obes Metab. 2020 Nov;22(11):2120-2132. doi: 10.1111/dom.14131. Epub 2020 Aug 20.
PubMed 32613714
Maybodi FR, Fakhari M, Tavakoli F. Effects of omega-3 supplementation as an adjunct to non-surgical periodontal therapy on periodontal parameters in periodontitis patients: a randomized clinical trial. BMC Oral Health. 2022 Nov 21;22(1):521. doi: 10.1186/s12903-022-02569-5.
PubMed 36414947
Castro Dos Santos NC, Andere NMRB, Araujo CF, de Marco AC, Kantarci A, Van Dyke TE, Santamaria MP. Omega-3 PUFA and aspirin as adjuncts to periodontal debridement in patients with periodontitis and type 2 diabetes mellitus: Randomized clinical trial. J Periodontol. 2020 Oct;91(10):1318-1327. doi: 10.1002/JPER.19-0613. Epub 2020 Jun 21.
PubMed 32103495
Benincasa G, Liguori MG, Tarallo F, Saccomanno S, Mancini L, Marchetti E. The role of omega-3 polyunsaturated fatty acids in the non-surgical management of periodontitis: a systematic review and meta-analysis. Front Oral Health. 2026 Mar 13;7:1761032. doi: 10.3389/froh.2026.1761032. eCollection 2026.
PubMed 41907859
Savran L, Saglam M. Clinical effects of omega-3 fatty acids supplementation in the periodontal treatment of smokers and non-smokers with periodontitis: a retrospective study. Clin Oral Investig. 2024 Jul 20;28(8):437. doi: 10.1007/s00784-024-05835-8.
PubMed 39031219
Stando-Retecka M, Piatek P, Namiecinska M, Bonikowski R, Lewkowicz P, Lewkowicz N. Clinical and microbiological outcomes of subgingival instrumentation supplemented with high-dose omega-3 polyunsaturated fatty acids in periodontal treatment - a randomized clinical trial. BMC Oral Health. 2023 May 13;23(1):290. doi: 10.1186/s12903-023-03018-7.
PubMed 37179297
Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
PubMed 32383274
Rampally P, Koduganti RR, Ganapathi SN, Panthula VR, Surya PJ. Comparison of effectiveness of low-dose aspirin versus omega-3 fatty acids as adjuvants to nonsurgical periodontal therapy in Type II diabetic patients with chronic periodontitis. J Indian Soc Periodontol. 2019 May-Jun;23(3):249-256. doi: 10.4103/jisp.jisp_528_18.
PubMed 31143006
Stando M, Piatek P, Namiecinska M, Lewkowicz P, Lewkowicz N. Omega-3 Polyunsaturated Fatty Acids EPA and DHA as an Adjunct to Non-Surgical Treatment of Periodontitis: A Randomized Clinical Trial. Nutrients. 2020 Aug 27;12(9):2614. doi: 10.3390/nu12092614.
PubMed 32867199
Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.
PubMed 29926495
Miroult C, Lasserre J, Toma S. Effects of Omega-3 as an adjuvant in the treatment of periodontal disease: A systematic review and meta-analysis. Clin Exp Dent Res. 2023 Aug;9(4):545-556. doi: 10.1002/cre2.736. Epub 2023 Jun 21.
PubMed 37345207
Neprelyuk OA, Zhad'ko SI, Romanenko IG, Kriventsov MA. Adjunctive use of omega-3 fatty acids in combination with low-dose aspirin in periodontitis: Systematic review and meta-analysis. J Periodontal Res. 2023 Dec;58(6):1128-1138. doi: 10.1111/jre.13191. Epub 2023 Oct 3.
PubMed 37787044
Araujo CF, Andere NMRB, Castro Dos Santos NC, Ferraz LFF, Miguel MMV, Mathias-Santamaria IF, Monteiro MF, Shaddox LM, Casarin RCV, Santamaria MP. Omega-3 and aspirin in the nonsurgical treatment of grade C periodontitis: A randomized clinical trial. J Periodontol. 2025 Aug;96(8):881-893. doi: 10.1002/JPER.24-0322. Epub 2025 Feb 14.
PubMed 39950354

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel

All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Non-surgical Periodontal Therapy in Combination With Aspirin and Omega-3 Fatty Acids.
ClinicalTrials.gov ID: NCT07523841
Acronym / sponsor ID: 1223/HĐĐĐ
Conditions: Periodontitis, Periodontitis (Stage 3)
Keywords: Periodontitis, Host Modulation Therapy, Non-surgical Periodontal Therapy, Omega-3 fatty acids, low-dose Aspirin
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Hanoi Medical UniversityUniversity, hospital or other
Study start: 1 Apr 2023 (actual)
Primary completion: 1 Apr 2027 (estimated)
Study completion: 1 May 2027 (estimated)
First posted: 13 Apr 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.

Is the combination of Omega-3 and Aspirin more effective than Omega-3 alone or standard non-surgical treatment in treating periodontitis?

Researchers will compare three groups:

Control group: Scaling and root planing (SRP) only.

Intervention group 1: SRP combined with Omega-3 fatty acids.

Intervention group 2: SRP combined with Omega-3 fatty acids and 81mg Aspirin.

The comparison aims to see if the combined therapy (Intervention group 2) provides superior anti-inflammatory effects and better clinical healing compared to the other groups.

Participants will:

Undergo clinical screening and selection based on study criteria.

Be randomly assigned to one of the three treatment arms.

Receive non-surgical periodontal treatment (scaling and root planing).

Take prescribed supplements (Omega-3 or Omega-3 combined with 81mg Aspirin) according to their assigned group.

Provide blood samples to measure changes in biochemical markers (IL-6, CRP).

Detailed description

Rationale Periodontitis is a chronic inflammatory disease caused by the host's immune response to pathogenic microorganisms, leading to clinical attachment loss and alveolar bone destruction. While non-surgical periodontal therapy (Scaling and Root Planing - SRP) is the gold standard, some patients experience disease progression due to residual subgingival biofilms. This study explores Host Modulation Therapy (HMT) as an adjunct to SRP. The combination of Omega-3 fatty acids and low-dose Aspirin (81mg) is hypothesized to enhance the resolution of inflammation. Omega-3 serves as a substrate for pro-resolving mediators (Resolvins, Protectins, Maresins), while Aspirin triggers the synthesis of Aspirin-triggered Lipoxins via the COX-2 pathway. This synergistic approach aims to reduce systemic pro-inflammatory markers, specifically Interleukin-6 (IL-6) and C-reactive protein (CRP), and improve clinical healing.
Detailed Study Design This is a randomized controlled clinical trial involving 120 participants. Randomization: Participants who meet the inclusion criteria are randomly assigned to one of three groups (1:1:1 ratio). Randomization is performed using Excel software (RAND function) to generate a random sequence. Allocation Concealment: Group assignments are placed in sealed, opaque envelopes and managed by a researcher not directly involved in the clinical treatment to ensure unbiased allocation.
Selection and Exclusion Criteria Inclusion Criteria: Age ≥ 20 years. Diagnosed with Stage III Periodontitis (Grade B or C) according to the 2017 AAP/EFP classification. Minimum of 16 natural teeth (excluding third molars and teeth indicated for extraction); at least 6 sites with Probing Pocket Depth (PPD) and Clinical Attachment Loss (CAL) ≥5mm, with bleeding on probing. No periodontal treatment in the last 3 months; non-smokers Exclusion Criteria: Systemic conditions: Mental illness, HIV, autoimmune diseases, chronic hematological, renal, or respiratory diseases, Type 2 diabetes, or obesity. Pregnancy or breastfeeding. Current use of ≥1g Omega-3/day or anticoagulants (Warfarin, Clopidogrel). History of gastrointestinal bleeding or peptic ulcers; allergy/hypersensitivity to Aspirin or Omega-3.
Intervention Procedures All participants receive standard non-surgical periodontal therapy, followed by a 30-day supplement regimen: Non-Surgical Periodontal Treatment (All Groups): Full-mouth ultrasonic scaling and deep root planing using Gracey curettes. Subgingival irrigation with 0.12% Chlorhexidine. Polishing and oral hygiene instructions (modified Bass technique and interdental cleaning). Group-Specific Regimens: Control Group: SRP only (no medicinal supplements). Intervention Group 1: SRP + Omega-3 (Now Foods, 300mg per capsule). Dosage: 4 capsules/day (2 in the morning, 2 in the evening after meals). Intervention Group 2: SRP + Omega-3 (4 capsules/day) + Aspirin 81mg (Agimexpharm). Dosage: 1 Aspirin tablet/day after breakfast.
Follow-up and Outcome Measures The study includes a long-term follow-up period of 24 months. Participants will return for re-examination at T1 (3 months), T2 (6 months), T3 (12 months), and T4 (24 months).

Biochemical Evaluation: Venous blood samples will be collected at each time point to quantify serum levels of IL-6 and CRP.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: This study is designed as a triple-arm, parallel-group randomized controlled trial with a 1:1:1 allocation ratio. The study employs an assessor-blind (single-blind) masking approach to ensure the objectivity of the results. Key features of the study model include: * Blinding/Masking: The clinical examiners responsible for measuring periodontal parameters (PPD, CAL, FMPS, BOP, GI) and the laboratory technicians performing the biochemical assays (IL-6, CRP) are kept blinded to the treatment group assignments of all participants. * Allocation: After the initial screening and baseline data collection, participants are assigned to one of three groups: Control (SRP only), Intervention 1 (SRP + Omega-3), or Intervention 2 (SRP + Omega-3 + Aspirin). * Longitudinal Assessment: The model follows a longitudinal design with evaluations at baseline and four subsequent follow-up points (3, 6, 12, and 24 months post-intervention). This structure allows for the assessment of both the immediate anti-in

Arm	Type	Receives
SRP only	Active comparator	Procedure: Scaling and Root Planing (SRP)Full-mouth ultrasonic scaling and deep root planing using Gracey curettes. Subgingival irrigation with 0.12% Chlorhexidine. Polishing and oral hygiene instructions (modified Bass technique and interdental cleaning).
SRP + Omega-3	Experimental	Procedure: Scaling and Root Planing (SRP), Dietary Supplement: Omega-3 Fatty AcidsSRP + Omega-3 (Now Foods, 300mg per capsule). Dosage: 4 capsules/day (2 in the morning, 2 in the evening after meals).
SRP + Omega-3 + Aspirin	Experimental	Procedure: Scaling and Root Planing (SRP), Dietary Supplement: Omega-3 Fatty Acids, Drug: Low-dose aspirinSRP + Omega-3 (4 capsules/day) + Aspirin 81mg (Agimexpharm). Dosage: 1 Aspirin tablet/day after breakfast.

Who may qualify

Ages: 20 days and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Age ≥ 20 years. Diagnosed with Stage III Periodontitis (Grade B or C) according to the 2017 AAP/EFP classification.
Minimum of 16 natural teeth (excluding third molars and teeth indicated for extraction); at least 6 sites with Probing Pocket Depth (PPD) and Clinical Attachment Loss (CAL) ≥5mm, with bleeding on probing.
No periodontal treatment in the last 3 months; non-smokers

Key exclusion criteria (2 listed)

Systemic conditions: Mental illness, HIV, autoimmune diseases, chronic hematological, renal, or respiratory diseases, Type 2 diabetes, or obesity.
Pregnancy or breastfeeding. Current use of ≥1g Omega-3/day or anticoagulants (Warfarin, Clopidogrel). History of gastrointestinal bleeding or peptic ulcers; allergy/hypersensitivity to Aspirin or Omega-3.

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
Scaling and Root Planing (SRP)Full-mouth ultrasonic scaling and deep root planing using Gracey curettes, followed by subgingival irrigation with 0.12% Chlorhexidine.	Procedure or surgery	SRP + Omega-3, SRP + Omega-3 + Aspirin, SRP only
Omega-3 Fatty AcidsOmega-3 (300mg per capsule: 180mg EPA/120mg DHA). Dosage: 4 capsules/day for 30 days.	Dietary supplement	SRP + Omega-3, SRP + Omega-3 + Aspirin
Low-dose aspirin81mg Aspirin (Agimexpharm). Dosage: 1 tablet/day for 30 days.	Drug	SRP + Omega-3 + Aspirin

Primary outcome

Probing Pocket Depth (PPD)
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Measured as the distance from the gingival margin to the bottom of the periodontal pocket using a William's periodontal probe. Values are reported in millimeters (mm). Higher values indicate deeper pockets and greater periodontal disease severity.
Serum Interleukin-6 (IL-6) Concentration
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Quantification of serum IL-6 levels using the electrochemiluminescence immunoassay (ECLIA) to evaluate systemic anti-inflammatory effects. Values are reported in picograms per milliliter (pg/mL). Higher values indicate higher levels of systemic inflammation.
Serum C-Reactive Protein (CRP) Concentration
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Quantitative assessment of high-sensitivity CRP in serum to monitor the systemic inflammatory response. Values are reported in milligrams per liter (mg/L). Higher values indicate a more significant systemic inflammatory response.
Modified Gingival Index (MGI)
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Assessment of the severity of gingival inflammation using the Modified Gingival Index (MGI) by Lobene. This is a non-invasive index based on visual inspection of the gingiva. The scale for each site ranges from 0 to 4 (0 = Absence of inflammation; 1 = Mild inflammation in any portion of the gingival unit; 2 = Mild inflammation in the entire gingival unit; 3 = Moderate inflammation; 4 = Severe inflammation). The outcome is reported as the mean score of all sites. Total scores range from 0 to 4, where higher scores indicate greater severity of gingival inflammation.

4 secondary outcomes

Full-mouth Bleeding on Probing (BOP) Percentage
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Clinical Attachment Loss (CAL)
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Full-mouth Plaque Score (FMPS)
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months
Lactate Dehydrogenase (LDH) Levels
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 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 15 Apr 2026.
Background: PubMed 32613714Montero E, Lopez M, Vidal H, Martinez M, Virto L, Marrero J, Herrera D, Zapatero A, Sanz M. Impact of periodontal therapy on systemic markers of inflammation in patients with metabolic syndrome: A randomized clinical trial. Diabetes Obes Metab. 2020 Nov;22(11):2120-2132. doi: 10.1111/dom.14131. Epub 2020 Aug 20.
Background: PubMed 36414947Maybodi FR, Fakhari M, Tavakoli F. Effects of omega-3 supplementation as an adjunct to non-surgical periodontal therapy on periodontal parameters in periodontitis patients: a randomized clinical trial. BMC Oral Health. 2022 Nov 21;22(1):521. doi: 10.1186/s12903-022-02569-5.
Background: PubMed 32103495Castro Dos Santos NC, Andere NMRB, Araujo CF, de Marco AC, Kantarci A, Van Dyke TE, Santamaria MP. Omega-3 PUFA and aspirin as adjuncts to periodontal debridement in patients with periodontitis and type 2 diabetes mellitus: Randomized clinical trial. J Periodontol. 2020 Oct;91(10):1318-1327. doi: 10.1002/JPER.19-0613. Epub 2020 Jun 21.
Background: PubMed 41907859Benincasa G, Liguori MG, Tarallo F, Saccomanno S, Mancini L, Marchetti E. The role of omega-3 polyunsaturated fatty acids in the non-surgical management of periodontitis: a systematic review and meta-analysis. Front Oral Health. 2026 Mar 13;7:1761032. doi: 10.3389/froh.2026.1761032. eCollection 2026.
Background: PubMed 39031219Savran L, Saglam M. Clinical effects of omega-3 fatty acids supplementation in the periodontal treatment of smokers and non-smokers with periodontitis: a retrospective study. Clin Oral Investig. 2024 Jul 20;28(8):437. doi: 10.1007/s00784-024-05835-8.
Background: PubMed 37179297Stando-Retecka M, Piatek P, Namiecinska M, Bonikowski R, Lewkowicz P, Lewkowicz N. Clinical and microbiological outcomes of subgingival instrumentation supplemented with high-dose omega-3 polyunsaturated fatty acids in periodontal treatment - a randomized clinical trial. BMC Oral Health. 2023 May 13;23(1):290. doi: 10.1186/s12903-023-03018-7.
Background: PubMed 32383274Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
Background: PubMed 31143006Rampally P, Koduganti RR, Ganapathi SN, Panthula VR, Surya PJ. Comparison of effectiveness of low-dose aspirin versus omega-3 fatty acids as adjuvants to nonsurgical periodontal therapy in Type II diabetic patients with chronic periodontitis. J Indian Soc Periodontol. 2019 May-Jun;23(3):249-256. doi: 10.4103/jisp.jisp_528_18.
Background: PubMed 32867199Stando M, Piatek P, Namiecinska M, Lewkowicz P, Lewkowicz N. Omega-3 Polyunsaturated Fatty Acids EPA and DHA as an Adjunct to Non-Surgical Treatment of Periodontitis: A Randomized Clinical Trial. Nutrients. 2020 Aug 27;12(9):2614. doi: 10.3390/nu12092614.
Background: PubMed 29926495Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.
Background: PubMed 37345207Miroult C, Lasserre J, Toma S. Effects of Omega-3 as an adjuvant in the treatment of periodontal disease: A systematic review and meta-analysis. Clin Exp Dent Res. 2023 Aug;9(4):545-556. doi: 10.1002/cre2.736. Epub 2023 Jun 21.
Background: PubMed 37787044Neprelyuk OA, Zhad'ko SI, Romanenko IG, Kriventsov MA. Adjunctive use of omega-3 fatty acids in combination with low-dose aspirin in periodontitis: Systematic review and meta-analysis. J Periodontal Res. 2023 Dec;58(6):1128-1138. doi: 10.1111/jre.13191. Epub 2023 Oct 3.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Periodontitis

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel

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.

Nguyen Ngoc Hoa, PhD study director

School of Dentistry, Hanoi Medical University, Vietnam

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 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 Vietnam. 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?

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?

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?

Probing Pocket Depth (PPD) (time frame: Baseline, 3 months, 6 months, 12 months, and 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07523841, which also lists 13 linked publications.

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 15 Apr 2026.