Evaluation of Effect of Nonsurgical Periodontal Therapy on Metabolic Control in Patients With Type II Diabetes
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Metabolic control
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Scalig and Rootplaning
patients will receive scaling and root planing therapy
Intervention: Scaling and Rootplaning (Procedure)
control
patients in control group will not receive periodontal treatment in the time period of the study
Outcomes
Primary Outcomes
Metabolic control
Time Frame: 3 months after treatment
fasting plasma glucose (FPG), HbA1c, TG, TC, high density lipoprotein cholesterol (HDL), and LDL are measured at baseline and 3 months after treatment.
Secondary Outcomes
- periodontal improvement after scaling and rootplaning(3 months after treatment)
Investigators
Amir Moeintaghavi
associate professor of periodontics
Mashhad University of Medical Sciences