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Randomized Controlled Trial
. 2021 Mar;25(3):1035-1045.
doi: 10.1007/s00784-020-03397-z. Epub 2020 Jun 17.

Effectiveness of a nutraceutical agent in the non-surgical periodontal therapy: a randomized, controlled clinical trial

Gaetano Isola  1 , Alessandro Polizzi  2 , Vincenzo Iorio-Siciliano  3 , Angela Alibrandi  4 , Luca Ramaglia  3 , Rosalia Leonardi  2
Affiliations
Randomized Controlled Trial

Effectiveness of a nutraceutical agent in the non-surgical periodontal therapy: a randomized, controlled clinical trial

Gaetano Isola et al. Clin Oral Investig. 2021 Mar.

Abstract

Objective: Nutraceutical agents have been demonstrated as adjuncts for the treatment of several inflammatory diseases. The present study analyzed and compared new nutraceutical agent as an adjunct to Scaling and root planing (SRP) versus SRP alone for the treatment of periodontitis.

Materials and methods: Sixty-six patients with moderate periodontitis were enrolled. Through a randomized design, the patients were randomly assigned to SRP + nutraceutical agent (test group) or SRP alone (control group). Patients were regularly examined the clinical, inflammatory mediators and visual analogue scale (VAS) changes over a 6-month period. Clinical attachment level (CAL) was the primary outcome variable chosen. Gingival crevicular fluid (GCF) inflammatory mediator change and the impact of treatment on VAS were evaluated through a linear regression model.

Results: Both treatments demonstrated an improvement in periodontal parameters compared with baseline. After 6 months of treatment, compared with the control group, the test group determined a significant probing depth (PD) (p = 0.003) and bleeding on probing (BOP) reduction (p < 0.001), while CAL gain was significantly obtained at 30 and 60 days after treatment (p < 0.05). In the test group, the level of inflammatory mediators was significantly reduced compared with the control group (p < 0.05). The linear regression analysis demonstrated that the nutraceutical agent exerted, in the test group, a significant influence on VAS at 6, 12, 24, and 48 h after treatment (p < 0.05).

Conclusions: Nutraceutical agent resulted in a more significant reduction in clinical, inflammatory mediators and short-term pain compared with SRP alone.

Clinical relevance: Nutraceutical agent, when combined with SRP, was demonstrated to be effective in reducing periodontal parameters and controlling the levels of inflammatory mediators and pain in patients with periodontitis.

Keywords: Baicalin; Gingival crevicular fluid; Nutraceutical agent; Pain; Palmitoylethanolamide; Periodontitis; Randomized controlled trials; Scaling and root planing.

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References

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