Clinical trial NCT01252082: Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics
Official title: Evaluation of Effect of Nonsurgical Periodontal Therapy on Metabolic Control in Patients With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Control
Keywords: metabolic control
fasting plasma glucose
glycated hemoglobin
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic control
timeFrame: 3 months after treatment
Secondary outcomes:
measure: periodontal improvement after scaling and rootplaning
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad Dental School, Mashhad University of Medical Sciences
state: Khorasan Razavi
Study officials:
affiliation: Associate professor,Mashhad Dental School, Mashhad University of Medical Sciences
name: Amir Moeintaghavi, DDS.,Ms.
role: STUDY_CHAIR
References:
citation: Moeintaghavi A, Arab HR, Bozorgnia Y, Kianoush K, Alizadeh M. Non-surgical periodontal therapy affects metabolic control in diabetics: a randomized controlled clinical trial. Aust Dent J. 2012 Mar;57(1):31-7. doi: 10.1111/j.1834-7819.2011.01652.x.