Resumen de Short-Term Effects of 2% Atorvastatin Dentifrice as an Adjunct to Periodontal Therapy: A Randomized Double-Masked Clinical Trial
David R. Rosenberg, Catherine X. Andrade, Alejandra Chaparro, Carolina M. Inostroza, Valeria Ramirez, Deborah Violant Holz, José Nart Molina
Background: The pleiotropic effects of statins, such as immunomodulation and anti-inflammatory effects, may also improve periodontal conditions. The aim of the present study is to assess the effectiveness of a dentifrice medicated with 2% atorvastatin in improving clinical periodontal parameters as a complement to non-surgical periodontal treatment (NSPT).
Methods: A randomized, double-masked clinical trial was performed with two parallel groups: 1) atorvastatin group (NSPT plus medicated 2% atorvastatin dentifrice) and 2) placebo group (NSPT plus placebo dentifrice). The effectiveness of these treatments was assessed using periodontal measurements obtained at baseline and 1 month later. The measurements were probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI), and periodontal inflamed surface area (PISA). Multiple linear regression models were used to compare outcome variables after adjusting for sex, diabetes, and tobacco use.
Results: A total of 36 individuals participated in this study (atorvastatin group, n = 18; placebo group, n = 18). Both groups showed improvements in periodontal parameters. The atorvastatin group showed a decrease of 297.63 mm2 in PISA (95% confidence interval = 76.04 to 519.23; P = 0.01), which was significantly greater than the reduction observed in the placebo group. There was also a significantly greater reduction in mean PD, percentage of sites with PD ≥5 mm, mean CAL, percentage of sites with CAL ≥5 mm, BOP, and GI in the atorvastatin group compared with the placebo group.
Conclusion: NSPT plus 2% atorvastatin medicated dentifrice was more effective in improving clinical periodontal parameters than NSPT plus a placebo dentifrice.
The common approach used in the treatment of periodontal disease, based primarily on the control of the etiologic agent (bacterial biofilm), has not been sufficient to reduce the high prevalence of periodontal disease.1 The emerging understanding regarding the role of host immune response in periodontal tissue breakdown and the specific inflammatory mechanism involved2-4 have encouraged researchers to explore new strategies in the management of periodontal disease. The presence of microbes associated with the progressive forms of periodontal disease in individuals with no evidence of disease progression suggests that the disease is a product of the immune response and inflammatory processes and not a result of the mere presence of the bacteria. Consequently, in susceptible individuals, the dysregulation of inflammatory and immune pathways leads to chronic inflammation, tissue breakdown, and disease.4 Recently, improvements have been reported in the status of periodontal disease associated with the use of statins.5,6 Statins are effective lipid-lowering agents with additional effects that are beneficial in treating periodontal disease, such as anti-inflammatory properties, stimulation of bone formation, and immunomodulatory actions.7-9 Various animal studies have demonstrated that statins decrease proinflammatory cytokines and mediators associated with bone loss.10,11 de Araujo et al.10 showed that rats with experimental periodontitis (EP) plus 10 mg/kg atorvastatin (a member of the statins) exhibited reverse bone loss caused by EP, decreasing proinflammatory cytokines, such as interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α), and reducing the markers of bone breakdown, such as matrix metalloproteinase (MMP-2 and MMP-9) and the receptor activator of nuclear factor κB ligand (RANKL). Dalcico et al.11 observed similar results in rats with EP. Treatment with oral simvastatin reduced the expression of inducible nitric oxide synthase, MMP-1, MMP-8, and RANKL and increased bone morphogenetic protein-2 and osteoprotegerin levels (inductors of bone formation) in the periodontal tissue.11 Recently, clinical trials have shown improvement in periodontal clinical parameters in medically healthy patients with the exception of having chronic periodontitis (CP) using 1.2% atorvastatin or 1.2% simvastatin (1.2 mg/0.1 mL) as a biodegradable controlled-release gel adjunct to scaling and root planing (SRP) in the treatment of CP, observing greater improvement with the use of atorvastatin.5,6 Despite the aforementioned evidence regarding the benefits of statins in periodontal disease, there remains a lack of information regarding the best vehicle, most appropriate doses, and confirmation of the true effects of statins in periodontal disease.
Considering that dentifrice is a complement used widely in oral hygiene techniques, dentifrice could be an effective medium with which to release statins, especially atorvastatin, which has demonstrated a greater topical effect.
The aim of the present investigation is to assess the effectiveness of a dentifrice medicated with 2% atorvastatin to improve clinical periodontal parameters in adult patients after non-surgical periodontal treatment (NSPT).
