Location: Endocrinology Department of Peja’s Regional Hospital and Dental Polyclinic in the city of Peja, Sloveniaįunding source: Slovenian Human Resources Development and Scholarship Fund (SHRDSF) for scholarship for Dr Dashnor Bukleta Trial design: open label, 4‐arm, parallel‐group RCT (we included the 2 arms comparing T2DM patients the other 2 arms compared non‐diabetic patients) HbA1C was analysed but numerical results were not reported other than in a graph from which data could not be extracted ![]() Quote: "All patients selected for analysis in the present study completed 6 months of the clinical trial" Random sequence generation (selection bias)Īllocated by sequentially numbered, sealed, opaque envelopesĬlinical examinations performed by 2 blinded and calibrated examiners Sample size calculation: "assuming a reduction of 2 mm in mean pocket depth, with 0.6 mm standard deviation in the IT group, and 1 mm mean pocket depth reduction, with 0.6 mm standard deviation in the ST group (90% statistical power and 5% significance level, the required sample size for each group was determined as 11 12 participants were recruited to account for potential dropouts and missing data"ĭata for HbA1c were presented in a graph and it was not possible to extract data from it for inclusion in meta‐analysis 1 Serum levels of interleukin (IL)‐6, IL‐17A, IL‐8, TNF‐α, monocyte chemoattractant protein (MCP)‐1 enzyme‐linked immunosorbent assay (ELISA) Stratification results presented for PD and CAL. "Periodontal therapy was carried out by an experienced periodontist" The procedures for the IT group were performed under local anaesthesia (3% prilocaine with felypressin), in two appointments lasting ~ 120 minutes each") Gp B (SRP) (n = 12): intensive therapy ‐ supragingival and subgingival scaling and root planing with 2 long appointments ("supra‐ and subgingival scaling and root planing, (in sites with PPD ≥ 4 mm) using an ultrasonic device and periodontal curettes. A Single appointment lasted ~ 60 minutes") Gp A (n = 12): supragingival scaling with a shorter appointment ("using an ultrasonic device and periodontal curettes (Hu‐Friedy ®, Chicago, USA). Other clinical investigations: TNF‐α, IL‐8, IL‐17A, IL‐6 MCP‐1, ELISA Metabolic control: not reported numerically Sex (M:F): unclear (authors report Gp A 56.3% female, Gp B 52.0% female)ĭiabetes type: T2DM, diagnosed according to WHO criteriaĭuration since diabetes diagnosis: minimum of 3 yrs Inclusion criteria: ≥ 35 yrs of age, confirmed diagnosis of T2DM for a period of over 3 yrs, generalised severe chronic periodontitis (number of PPD sites ≥ 30%, CAL > 4 mm, and BOP), and ≥ 15 teethĮxclusion criteria: pregnant women, smokers, people with BMI > 35 kg/m 2, or those who had received periodontal therapy, systemic antibiotic, or oral antiseptic therapy 6 mths prior to the studyĪge at baseline (yrs): Gp A 54.4 (SD 5.8), Gp B 52.0 (SD 3.3) ![]() Recruitment period: February 2011 to December 2013įunding source: "supported by the Fundação de Amparo à Pesquisa do Estado de SãoPaulo – FAPESP, São Paulo, Brazil, under protocol numbers 2011/06982‐4 10057‐4 18618‐5"
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