Materials and methods
teeth, type 2 diabetes mellitus, bleeding, Diabetes
METABOLIC DISEASES, BLEEDING, DIABETES MELLITUS TYPE 2, DIABETES, TYPE 2 DIABETES MELLITUS
This study was a randomised single-blinded controlled clinical trial. The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki. The protocol was approved by the National Medical Ethics Committee of the Republic of Slovenia (No: 0120–539/2015–2). A sample size of 12 patients per group was set to exceed a power of 80% (10 patients per group) to detect the difference of 1 mm in clinical attachment loss (CAL) and 1% glycated haemoglobin (HbA1c) between the groups with predicted values of CAL 3.5 mm and a variability of 1.3 mm and the groups with predicted values of HbA1c 8.0% and a variability of 1.5%.The subjects with type 2 diabetes mellitus were referred from the Department of Endocrinology, Diabetes and Metabolic Diseases of the University Medical Centre Ljubljana, to the Department of Dentistry and Periodontology of the University Medical Centre Ljubljana. Detailed dental and medical records were obtained. The inclusion criteria were as follows: age between 40 and 75 years, diabetes mellitus type 2 with an HbA1c value > 7.0%, at least ten teeth in the maxilla and mandible, and at least four teeth with a probing pocket depth ≥ 5 mm and bleeding on probing. The exclusion criteria were as follows: antibiotic treatment in the last 4 months, periodontal treatment in the last 6 months, and any change in antihyperglycaemic treatment 3 months prior to participation. Pregnant and lactating women, smokers, and former smokers who had stopped smoking less than 5 years before participation were also excluded. Subjects who met the inclusion criteria were invited to participate in the study. Each subject was informed in detail about the benefits and risks of the treatment and signed the informed consent form before participation.