Chronic Periodontitis Clinical Trial
Official title:
Evaluation of the Effectiveness of Intensive Periodontal Treatment as Compared to Conventional Periodontal Treatment on the Level of Glycosylated Hemoglobin in Patients With Decompensated Type 2 Diabetes Mellitus: Randomized Clinical Trial
Periodontitis is an infectious disease that destroys the tooth supporting tissues and
triggers a local and systemic immune response. Type 2 Diabetes Mellitus (DM2) is a risk
factor for periodontitis.Patients with DM2 and periodontitis have greater difficulty getting
and maintaining an appropriate glycemic control. It has been reported an average decrease of
0.4% in glycosylated hemoglobin levels (HbA1c) in patients periodontally treated versus
untreated. It is not has been established that periodontal treatment type in spaced sessions
(multiple sessions over a period of 4 weeks) or rapid and intensive (2 sessions in 24
hours), has a greater impact on glycemic control in type 2 diabetes patients.
Objective: To evaluate the effectiveness of intensive periodontal treatment modality as
compared with conventional on HbA1c level in periodontitis and DM2 decompensated patients.
It is proposed to conduct a clinical trial in 100 type 2 diabetic patients with poor
glycemic control defined as a glycated hemoglobin (HbA1c) ≥ 7% at last check, with
randomization stratified by referral center, with two parallel groups (1: 1). Diabetic
patients are in treatment and control in Diabetes Polyclinic Medical Specialty Center of the
University of the Andes or the medical polyclinic Joan Alsina in San Bernardo . All
decompensated DM2 patients diagnosed with chronic periodontitis will receive periodontal
treatment based on 2 different periodontal treatment modalities: the first and most
traditional is by spaced sessions by quadrant in 1 weekly session (5 sessions). The second
form of treatment corresponds to an intensive periodontal treatment, whole mouth in 24
hours.
All patients will be given an initial periodontal examination with manual north carolina
periodontal probe, performed by a single operator previously calibrated.
Periodontal status will be determine according to the classification of Page and Eke (2007)
and periodontal wound size (PISA) will be also determine. Also, will be measured
inflammatory mediators and cytokines in both plasma and gingival crevicular fluid (GCF) by
ELISA test. The data were entered into a medical record designed specifically for this study
and the variables will be recorded prior and at 3 and 6 months after periodontal therapy.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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