Type 2 Diabetes Mellitus
Conditions
Interventions
This is a parallel, two-arm interventional study with single-group allocation, non-randomized and unmasked. Participants will be allocated into two groups according to glycemic status: control group (
n = 25) and DM2 group (individuals with type 2 diabetes mellitus
n = 25), totaling 50 participants. There will be no randomization, as allocation will be based on the participants’ systemic condition. All individuals will undergo conventional endodontic treatment i
Sponsors
Faculdade de Odontologia do Campus de Araçatuba da Universidade Estadual Paulista Júlio de Mesquita Filho
Faculdade de Odontologia do Campus de Araçatuba da Universidade Estadual Paulista Júlio de Mesquita Filho
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Men and women; aged between 18 and 80 years; diagnosis of apical periodontitis confirmed by intraoral radiography; presence of apical radiolucency; teeth with no response to pulp vitality testing; previously endodontically treated teeth; teeth with or without associated clinical signs and symptoms; prediabetic and diabetic patients with glycated hemoglobin (HbA1c) levels between 5.5% and 9%
Exclusion criteria
Exclusion criteria: Use of immunosuppressive drugs; hereditary coagulation disorders, including hemophilia A, hemophilia B, or von Willebrand disease; use of antibiotics within the last 3 months; pregnancy; chronic liver disease; chronic kidney disease; history of dental trauma; fractured teeth; perforated teeth; internal root resorption; retreatment cases involving calcified canals; incomplete root development; individuals with systemic conditions that may interfere with treatment; previously endodontically treated canals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the reduction of intracanal bacterial load and the regression of periapical lesions in teeth with chronic apical periodontitis after endodontic treatment, determined by bacterial quantification using real-time polymerase chain reaction from samples collected from the root canal during endodontic treatment and by cone beam computed tomography performed at baseline and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the intensity of postoperative pain after endodontic treatment, determined using the Visual Analog Scale immediately after treatment and after 6 months, allowing comparison between groups and over time;Evaluate changes in glycemic control after endodontic treatment between groups, determined by fasting blood glucose and glycated hemoglobin measurements performed at baseline and after 6 months, allowing intra- and intergroup comparisons;Evaluate oral health-related quality of life after endodontic treatment between groups, determined using the Oral Health Impact Profile questionnaire performed at baseline and after 6 months, allowing evaluation of changes over time and between groups;Evaluate changes in salivary parameters and oxidative stress after endodontic treatment between groups, determined through biochemical analysis of unstimulated saliva collected at baseline, during treatment, and after 6 months, including salivary flow rate, pH, buffering capacity, total antioxidant capacity, total oxidant capacity, uric acid, total proteins, amylase, electrolytes, thiobarbituric acid reactive substances, protein carbonyls, and nitric oxide, allowing comparison between groups and over time | — |
Countries
BR
Contacts
Public ContactRogério Jacinto
Faculdade de Odontologia de Araçatuba - Universidade Estadual Paulista
Outcome results
None listed