Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients
The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group, Control Group.
Background: Periodontitis and diabetes are both highly prevalent conditions, and the
association between these two common diseases has been recognised by dental professionals
for many years.
Aim: The main objective is to evaluate the effect of nonsurgical periodontal treatment on
serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM).
Methods: This study is a 6-month, single-masked, randomized clinical trial.A total of 90
patients with diabetes and chronic generalized periodontal disease will be randomly divided
into 2 groups: Treatment Group (TG) (Oral Hygiene Instructions (OHI) + scaling and root
planing (RAR) using ultrasound device and Gracey curettes); Control Group (CG) (OHI +
supragingival removal of plaque and calculus with ultrasonic device). CG patients receive
salvage therapy if a significant worsening of their periodontal status and / or metabolic
observed. Periodontal assesment (probing pocket depth (PPD), gingival index (GI), and plaque
index (PI)) and systemic assesment (random blood sugar, glycosylated hemoglobin (HbA1C), and
salivary cytokines) and bacterial asessment at baseline and 3, 6 months after treatment is
performed. There will be a single examiner, blind and calibrated to improve reproducibility.
The investigators' hypothesis is that non-surgical periodontal treatment reduces HbA1c,
improving metabolic control in patients with DM
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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