Research efficacy of gaseous ozone therapy as an adjuvant to periodontal treatment on oxidative stress mediators in patients with type 2 diabetes: a randomized clinical trial.

BACKGROUND: Chronic inflammation and cumulative oxidative stress have been theorized as two common pathways of the interconnection between periodontitis and diabetes. Improvement in oxidizing status has been demonstrated in periodontal patients with diabetes treated with proper non-surgical periodontal treatment. In addition to periodontal treatment, Gaseous ozone therapy has been reported to possess anti-inflammatory properties and the ability to stimulate the endogenous antioxidant defence mechanism. To date, the antioxidant effect of gaseous ozone, in addition with periodontal treatment in diabetic patients, has been examined in only one study. The aim of this study was to determine the efficacy of gaseous ozone therapy as an alternative approach to supporting non-surgical periodontal therapy (NSPT), aimed at improving antioxidant machinery and interfering with ROS production on plasma levels in diabetic individuals diagnosed with moderate or severe periodontitis. METHODS: One hundred and eighty patients with periodontitis and type 2 diabetes mellitus were randomly assigned to receive non-surgical periodontal treatment (NSPT) plus gaseous ozone therapy (A) NSPT alone (B). Clinical and periodontal parameters -Bleeding on probing (BOP), Periodontal pocket depth (PPD), and Clinical attachment Level (CAL)- and plasma levels of oxidant-antioxidant (TOS- TAOS) levels, glutathione (GSH), and malondialdehyde (MDA) were recorded at baseline and at 3- (T1) and at 6-months (T2) after treatment. RESULTS: Both treatments were efficacious in reducing clinical parameters. However, there were no significant differences regarding oxidative stress parameters in group A compared to group B. CONCLUSIONS: In the present study, gaseous ozone therapy did not enhance the effect of periodontal treatment in reducing oxidative stress in plasma levels of periodontitis patients with type II diabetes. TRIAL REGISTRATION: The study was registered with ISRCTN1728169 (23/07/2022).

The Gaseous Ozone Therapy as a Promising Antiseptic Adjuvant of Periodontal Treatment: A Randomized Controlled Clinical Trial.

BACKGROUND: the establishment of periodontitis is regulated by the primary etiological factor and several individual conditions including the immune response mechanism of the host and individual genetic factors. It results when the oral homeostasis is interrupted, and biological reactions favor the development and progression of periodontal tissues damage. Different strategies have been explored for reinforcing the therapeutic effect of non-surgical periodontal treatment of periodontal tissue damage. Gaseous ozone therapy has been recognized as a promising antiseptic adjuvant, because of its immunostimulating, antimicrobial, antihypoxic, and biosynthetic effects. Then, we hypothesized that the adjunct of gaseous ozone therapy to standard periodontal treatment may be leveraged to promote the tissue healing response. METHODS: to test this hypothesis, we conducted a prospective randomized study comparing non-surgical periodontal treatment plus gaseous ozone therapy to standard therapy. A total of 90 healthy individuals with moderate or severe generalized periodontitis were involved in the study. The trial was conducted from September 2019 to October 2020. Forty-five patients were randomized to receive scaling and root-planning (SRP) used as conventional non-surgical periodontal therapy plus gaseous ozone therapy (GROUP A); forty-five were allocated to standard treatment (GROUP B). The endpoint was defined as the periodontal response rate after the application of the ozone therapy at 3 months and 6 months, defined as no longer meeting the criteria for active periodontitis. Statistical analysis was performed employing SPSS v.18 Chicago: SPSS Inc. RESULTS: periodontal parameters differed significantly between patients treated with the two distinct procedures at 3 months (p ≤ 0.005); a statistically significant difference between groups was observed from baseline in the CAL (p ≤ 0.0001), PPD (p ≤ 0.0001) and BOP (p ≤ 0.0001) scores. CONCLUSIONS: The present study suggests that SRP combined with ozone therapy in the treatment of periodontitis revealed an improved outcome than SRP alone.

Inflammatory Status and Glycemic Control Level of Patients with Type 2 Diabetes and Periodontitis: A Randomized Clinical Trial.

BACKGROUND: Based on the holistic approach to prevention diabetic disease, the role of periodontal inflammation in type 2 diabetes mellitus (T2DM) is under intensive scrutiny. Data from clinical trials have shown benefit from a periodontal therapy in providing patients with type 2 diabetes improvement despite relatively disappointing long-terms response rates. The aim of this study was to investigate the short-term glycemic control level and systemic inflammatory status after periodontal therapy. METHODS: This was a randomized trial with a 6-months follow-up. Participants aged 56.4 ± 7.9 years with diagnosed type 2 diabetes and periodontitis were enrolled. Among the 187 type 2 diabetic patients, 93 were randomly assigned to receive non-surgical periodontal treatment immediately and 94 to receive the delayed treatment. Within and between groups comparison was done during the study period, and the differences between groups were assessed. RESULTS: The difference between HbA1c values at baseline (Mdn = 7.7) and 6 months after non-surgical periodontal treatment (Mdn = 7.2) was statistically significant, U = 3174.5, p = 0.012, r = 0.187. However, although technically a positive correlation, the relationship between the glycated hemoglobin value and periodontal variables was weak. The differences between both the groups over 6 months were not statistically considerable, failing to reach statistical significance. At 6 months the difference between groups about the C-reactive protein (CRP) levels was statistically significant, U=1839.5, p = 0, r = 0.472, with a lower concentration for the intervention group. Furthermore, the intervention group showed a statistically significant difference between baseline and 6 months evaluation (U = 2606.5, p = 0, r = 0.308). CONCLUSIONS: The periodontal intervention potentially may allow individuals with type 2 diabetes to improve glycemic control and CRP concentrations, and diabetes alters the periodontal status.

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.

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.