The Effect of Gaseous Ozone Therapy in Conjunction with Periodontal Treatment on Glycated Hemoglobin Level in Subjects with Type 2 Diabetes Mellitus: An Unmasked Randomized Controlled Trial
Department of Basic Medical Sciences, Neurosciences and Sense Organs, “Aldo Moro” University of Bari, 70121 Bari, Italy
Complex Operative Unit of Odontostomatology, Hospital S.S. Annunziata, 66100 Chieti, Italy
Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy
Department of Emergency and Organ Transplantation, Division of Plastic and Reconstructive Surgery, “Aldo Moro” University of Bari, 70121 Bari, Italy
Ionian Department (DJSGEM), “Aldo Moro” University of Bari, 70121 Bari, Italy
Department of Clinical Disciplines, School of Technical Medical Sciences, University A. Xhuvani, 3001 Elbasan, Albania
Department of Oral Science, Nano and Biotechnology and CeSi-Met University of Chieti-Pescara, 66100 Chieti, Italy
Department of Metabolic and Genetic Diseases, Giovanni XXIII Children’s Hospital, 70126 Bari, Italy
Authors to whom correspondence should be addressed.
Antonio Scarano and Maurizio Delvecchio have thus to be equally regarded as co-last authors.
Int. J. Environ. Res. Public Health 2020, 17(15), 5467; https://doi.org/10.3390/ijerph17155467
Received: 2 June 2020 / Revised: 16 July 2020 / Accepted: 24 July 2020 / Published: 29 July 2020
(This article belongs to the Special Issue Diabetes: Screening, Prevention, Diagnosis and Therapy)
Background: It is established that inflammation is involved in the pathogenesis of Type 2 Diabetes Mellitus (T2DM) by promoting insulin resistance and impaired beta cell function in the pancreas. Among the hypothesized independent risk factors implicated in the pathogenetic basis of disease, periodontal infection has been proposed to promote an amplification of the magnitude of the advanced glycation end product (AGE)-mediated upregulation of cytokine synthesis and secretion. These findings suggest an interrelationship between periodontal disease and type 2 diabetes, describing poor metabolic control in subjects with periodontitis as compared to nondiabetic subjects and more severe periodontitis in subjects with T2DM as compared to a healthy population, with a significant positive correlation between periodontal inflammatory parameters and glycated hemoglobin level. Results from clinical trials show that periodontal treatment is able to improve glycemic control in subjects with diabetes. Many therapeutic strategies have been developed to improve periodontal conditions in conjunction with conventional treatment, among which ozone (O3) is of specific concern. The principal aim of this trial was to compare the clinical effectiveness of an intensive periodontal intervention consisting of conventional periodontal treatment in conjunction with ozone gas therapy in reducing glycated hemoglobin level in type 2 diabetic patients and standard periodontal treatment. Methods: This study was a 12-month unmasked randomized trial and included 100 patients aged 40–74 years older, with type 2 diabetes mellitus diagnosed. All the patients received conventional periodontal treatment, or periodontal treatment in conjunction with ozone gas therapy in a randomly assigned order (1:1). The primary outcome was a clinical measure of glycated hemoglobin level at 3, 6, 9 and 12 months from randomization. Secondary outcomes were changes in periodontal inflammatory parameters. Results: At 12 months, the periodontal treatment in conjunction with ozone gas therapy did not show significant differences than standard therapy in decreasing glycated hemoglobin (HbA1C) level and the lack of significant differences in balance is evident. Conclusions: Although the change was not significant, periodontal treatment in conjunction with the gaseous ozone therapy tended to reduce the levels of glycated hemoglobin. The study shows a benefit with ozone therapy as compared to traditional periodontal treatment.