Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics

Study Overview
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Brief Summary
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The purpose of this study is to determine whether nonsurgical periodontal therapy is effective in the metabolic control of patients with type II Diabetes mellitus.

Detailed Description
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Type 2 diabetes mellitus (DM2), the most common type of diabetes, is characterized by hyperglycemia, hyperlipidemia, and associated complications. The classic major complications of diabetes are microangiopathy, nephropathy, neuropathy, macrovascular disease, delayed wound healing, and periodontitis. There is an interacting, complex relationship between diabetes and periodontitis.Many studies have shown a greater incidence and a greater severity of periodontitis in diabetic patients.Meanwhile, a number of studies have suggested that periodontitis may actually be a risk factor for diabetic complications as well. This study is performed to investigate the effects of non-surgical periodontal therapy on metabolic control in DM2 patients.

Official Title
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Evaluation of Effect of Nonsurgical Periodontal Therapy on Metabolic Control in Patients With Type II Diabetes

Conditions
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Metabolic Control

Intervention / Treatment
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* Procedure: Scaling and Rootplaning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) mild to moderate periodontitis according to the criteria of the American Academy of Periodontology (32); (2) diagnosis of DM2 with glycated hemoglobin (HbA1c) values over 7%; (3) no major diabetic complications; (4) blood sugar controlled with glybenclamide and metformin, without insulin administration; and (5) no systemic antibiotic administration or periodontal treatment within the last 6 months. Exclusion Criteria: (1) presence of systemic diseases other than DM2 that may influence the course of periodontal disease; (2) intake of immunosuppressive drugs, steroids, hydantoin, or non-steroidal anti-inflammatory drugs; (3) tobacco use; (4) pregnancy or intention to become pregnant during the study period; (5) fixed orthodontic appliances; and (5) refusal or inability to give informed consent

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scalig and Rootplaning<br>patients will receive scaling and root planing therapy | Procedure: Scaling and Rootplaning<br>* All patients in the test group receive scaling and rootplaning under local anesthesia<br>* Other names: control group;|
| No Intervention: control<br>patients in control group will not receive periodontal treatment in the time period of the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic control | fasting plasma glucose (FPG), HbA1c, TG, TC, high density lipoprotein cholesterol (HDL), and LDL are measured at baseline and 3 months after treatment. | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periodontal improvement after scaling and rootplaning | Periodontal parameters (Plaque index, Gingival index, Clinical Attachment level and Probing depth)are Measured at baseline and 3 months after treatment | 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic control, fasting plasma glucose, glycated hemoglobin