Non-surgical Periodontitis Treatment With Aspirin and Omega-3

NCT07523841 | Active Not Recruiting

• 1 other identifier: 1223/HĐĐĐ
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aims to answer are: 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).

Conditions

Periodontitis; Periodontitis (Stage 3)

Keywords

Periodontitis; Host Modulation Therapy; Non-surgical Periodontal Therapy; Omega-3 fatty acids; low-dose Aspirin

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, 3 months, 6 months, 12 months, and 24 months

Secondary Outcomes (4)

• Full-mouth Bleeding on Probing (BOP) Percentage

  Baseline, 3 months, 6 months, 12 months, and 24 months

• Clinical Attachment Loss (CAL)

  Baseline, 3 months, 6 months, 12 months, and 24 months

• Full-mouth Plaque Score (FMPS)

  Baseline, 3 months, 6 months, 12 months, and 24 months

• Lactate Dehydrogenase (LDH) Levels

  Baseline, 3 months, 6 months, 12 months, and 24 months

Study Arms (3)

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).

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).

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.

Procedure: Scaling and Root Planing (SRP); Dietary Supplement: Omega-3 Fatty Acids; Drug: Low-dose aspirin

Interventions

Scaling and Root Planing (SRP) PROCEDURE

Full-mouth ultrasonic scaling and deep root planing using Gracey curettes, followed by subgingival irrigation with 0.12% Chlorhexidine.

SRP + Omega-3; SRP + Omega-3 + Aspirin; SRP only

Omega-3 Fatty Acids DIETARY_SUPPLEMENT

Omega-3 (300mg per capsule: 180mg EPA/120mg DHA). Dosage: 4 capsules/day for 30 days.

SRP + Omega-3; SRP + Omega-3 + Aspirin

Low-dose aspirin DRUG

81mg Aspirin (Agimexpharm). Dosage: 1 tablet/day for 30 days.

SRP + Omega-3 + Aspirin

Eligibility Criteria

• Age: 20 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Department of Stomatology, 108 Military Central Hospital

Hanoi, Hanoi, 11600, Vietnam

Location

Related Publications (14)

• 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.

  PMID: 32613714 BACKGROUND

• Maybodi FR,Fakhari M,Tavakoli F

  BACKGROUND

• Castro Dos Santos NC,Andere NMRB,Araujo CF,de Marco AC,Kantarci A,Van Dyke TE,Santamaria MP

  BACKGROUND

• Benincasa G,Liguori MG,Tarallo F,Saccomanno S,Mancini L,Marchetti E

  BACKGROUND

• Savran L,Sağlam M

  BACKGROUND

• Stańdo-Retecka M,Piatek P,Namiecinska M,Bonikowski R,Lewkowicz P,Lewkowicz N

  BACKGROUND

• 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.

  PMID: 32383274 BACKGROUND

• 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.

  PMID: 31143006 BACKGROUND

• 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.

  PMID: 32103495 BACKGROUND

• 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.

  PMID: 32867199 BACKGROUND

• 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.

  PMID: 29926495 BACKGROUND

• 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.

  PMID: 37345207 BACKGROUND

• 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.

  PMID: 37787044 BACKGROUND

• 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.

  PMID: 39950354 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing; Fatty Acids, Omega-3; Aspirin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; 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

• Nguyen Ngoc Hoa, PhD

  School of Dentistry, Hanoi Medical University, Vietnam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

VN (1)