Influence of the persistence of active bacteria on the success of multiple session endodontic treatment in patients with type 2 diabetes mellitus:A prospective longitudinal study

Abstract

Although there is an association between chronic apical periodontitis (AP) and patients with type 2 diabetes mellitus (T2DM), the outcomes associated with the decreased success rate of endodontic treatment still remain uncertain and controversial. Microbial persistence appears to be the limiting factor contributing to the failure of endodontic treatment, directly or indirectly impacting pain control and quality of life. The objective of this clinical study will be to evaluate the total bacterial load and the species E. faecalis, P. gingivalis, T. forsythia, T. denticola, F. nucleatum and C. Albicans - by molecular methods based on DNA and RNA, in patients with DM2 in comparison to normoglycemic patients, before and after chemo-mechanical preparation and evaluate the outcomes of: glycemic control, postoperative pain, improvement in quality of life and repair of periapical lesions by post-cone beam computed tomography (CBCT). treatment (6 months). 50 patients will be recruited, following the following inclusion and exclusion criteria: 18-80 years old, diagnosed with chronic AP. Participants will be allocated into two groups (n=25/group): DM2 with HbA1 = 6.5% and diagnosed with DM2 for more than 1 year; and a non-diabetic control group with HbA1c d 5.7%, all with a diagnosis of AP in at least 1 tooth. A structured questionnaire will be applied including presence or absence of DM2, duration of DM2, presence of cardiovascular disease, specific intake of metformin and statin drugs. Behavioral variables and information through the Oral Health Related Quality of Life questionnaire (OHIP-14) will be obtained; After taking an anamnesis, all patients will undergo a serum glycated hemoglobin (HbA1c) test and a CBCT test on the day of treatment initiation and after 6 months. Subjects will be followed at 2 weeks and 6 months. At each visit, blood samples will be collected and clinical and radiographic analyzes of the periapical condition will be collected. Collections will be made from inside the root canal: before biomechanical preparation (PQM) (S1), after PQM (S2) and after intracanal medication (two weeks - S3). At the end of the session, the VAS scale will be provided to evaluate the painful symptoms presented over periods of 24 hours, 48 hours and 7 days. The amount of total bacterial cells and specific species will be assessed by RNA gene-directed real-time quantitative polymerase chain reaction (qPCR). At 6 months of follow-up, volumetry of periapical bone destruction will be performed using CBCT using the ITK snap software. Statistics will be performed according to each type of analysis considering a significance level of 5% (p <0.05).