Melatonin as host modulating agent supporting nonsurgical periodontal therapy in patients affected by untreated severe periodontitis: A preliminary randomized, triple-blind, placebo-controlled study.

Abstract

The aim of the current clinical trial was to evaluate if the oral supplementation of melatonin after nonsurgical periodontal therapy (NSPT) determined a better periodontal healing than NSPT alone, in patients affected by untreated severe periodontitis. Melatonin's anti-inflammatory, antioxidant and immunomodulatory capacities, together with its pharmacokinetic and pharmacodynamic profiles are key characteristics that justify the therapeutic use for the treatment of periodontitis. This is a randomized, triple-blind, placebo-controlled study. Twenty patients were blindly randomized either to melatonin or placebo group. The melatonin group received NSPT and melatonin capsules 1mg per day for 1month, while the placebo, NSPT, and placebo capsules for 1month. The patients were evaluated at baseline and 6months after. Mean change from baseline probing depth (PD) was the primary outcome; site of probing was used as unit of analysis; FMBS (%) and FMPS (%) were also calculated. Mann-Whitney test was used to evaluate statistical significance (α=0.05). Melatonin was well tolerated by all patients. Both treatments were effective in reducing PD, but no statistical difference was found when comparing posttreatment PD (probing all sites), P=.62. When considering the primary outcome, melatonin administration resulted in greater mean PD change at 6months if compared to control group: for 4-5mm sites 1.86 (0.81) vs 1.04 (0.69), P=.00001 and for sites >5mm 3.33 (1.43) vs 2.11 (0.96), P=.00012. No difference was found for FMBS and FMPS. Current study, within its limitations, concluded that oral administration of melatonin (1mg per dayfor 30days) after one-stage full mouth NSPT determined a greater change from baseline PD if compared to NSPT alone, in untreated stage III periodontitis. This could provide a non-pharmacological support to improve periodontal healing of periodontal sites after NSPT.