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Melatonin as host modulating agent supporting nonsurgical periodontal therapy in patients affected by untreated severe periodontitis: A preliminary randomized, triple‐blind, placebo‐controlled study
Author(s) -
Tinto Manuel,
Sartori Matteo,
Pizzi Ileana,
Verga Alessandra,
Longoni Salvatore
Publication year - 2020
Publication title -
journal of periodontal research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.31
H-Index - 83
eISSN - 1600-0765
pISSN - 0022-3484
DOI - 10.1111/jre.12686
Subject(s) - melatonin , placebo , medicine , periodontitis , randomized controlled trial , statistical significance , clinical trial , mann–whitney u test , oral administration , gastroenterology , pharmacodynamics , crossover study , anesthesia , pharmacokinetics , pathology , alternative medicine
Objectives 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. Background 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. Methods 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 1 mg per day for 1 month, while the placebo, NSPT , and placebo capsules for 1 month. The patients were evaluated at baseline and 6 months 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). Results 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 6 months if compared to control group: for 4‐5 mm sites 1.86 (0.81) vs 1.04 (0.69), P = .00001 and for sites >5 mm 3.33 (1.43) vs 2.11 (0.96), P = .00012. No difference was found for FMBS and FMPS . Conclusion Current study, within its limitations, concluded that oral administration of melatonin (1 mg per day for 30 days) 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 .