Immunomodulators, associated or not with systemic antibiotics, to treat periodontitis: A 1-year multicenter, placebo-controlled, double-blind, randomized clinical trial
Abstract
Background: Immunomodulatory agents such as omega-3 (ω-3) and low-dose aspirin (ASA) have been proposed as effective adjuncts in the treatment of periodontitis. However, they still lack long-term studies and head-to-head evaluation with metronidazole (MTZ) and amoxicillin (AMX), the adjunct protocol with the strongest scientific evidence of clinical benefit. This study aimed to evaluate the clinical effects of (ω)-3 and ASA, alone or combined with MTZ + AMX, to treat periodontitis.
Methods: Adults with stage III/IV periodontitis were randomly allocated to receive: (i) subgingival instrumentation (SI) and placebo; (ii) SI with adjunctive MTZ (400 mg) + AMX (500 mg) three times/day for 14 days (ATB); (iii) SI with adjunctive ω-3 (3 g) + ASA (100 mg/day) for 6 months (IM); and (iv) SI with adjunctive ATB and IM (ATB + IM). The patients were followed for 1 year post-therapy.
Results: 109 patients were included. At 1 year, 58.6%, 57.7%, and 57.1% of patients receiving ATB, IM, and ATB+IM, respectively, achieved the treatment endpoint [≤4 sites with a probing depth (PD) of ≥5 mm], compared with 23.1% in the SI group (p = 0.023). Each adjunctive therapy resulted in a greater reduction in the number of sites with PD≥5 mm compared with SI (p < 0.05).
Conclusion: Adjunctive ATB, IM, or ATB+IM each provided clinically meaningful benefits beyond mechanical therapy. The results suggested no added benefit from combining ATB and IM. These findings support MTZ + AMX or ω-3 + ASA, without…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 109 participants or records.
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