Non-surgical Periodontitis Treatment With Aspirin and Omega-3

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).

Timeline

Start

2023-04-01

Primary completion

2027-04-01

Completion

2027-05-01

Publications

• Background 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.
• Background 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.
• 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.
• Background 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.
• Background 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.
• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications