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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01467674
Other study ID # 1721-D-08
Secondary ID
Status Completed
Phase N/A
First received November 1, 2011
Last updated November 8, 2011
Start date January 2008
Est. completion date May 2009

Study information

Verified date November 2011
Source Suleyman Demirel University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

The aim of this study was to investigate the impact of glycemic control on clinical periodontal status, levels of malondialdehyde (MDA), glutathione peroxidase (GSH-Px), reduced glutathione (GSH) and paraoxonase (PON) activity in gingival crevicular fluid (GCF) and blood samples of type 2 diabetes mellitus (T2DM) patients with chronic periodontitis (CP).


Description:

Reactive oxygen species (ROS) are products of normal cellular metabolism and play beneficial role in physiological functions. Overproduction of ROS and/or deficiency of enzymatic or non-enzymatic antioxidants, termed as oxidative stress, is involved in many pathological conditions such as Diabetes mellitus (DM) and chronic periodontitis (CP).

Several researches revealed that DM, with many determinants such as level of glycemic control, stands as a strong risk factor for periodontal diseases. On the other side, periodontal diseases induce an elevated chronic inflammatory state and exacerbated insulin resistance.

In the present study, the investigators examined the effect of glycemic control level on clinical periodontal status, levels of MDA, GSH-Px, GSH and PON activity in gingival crevicular fluid and blood samples of CP patients with T2DM.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- to present T2DM diagnosis by an endocrinologist for at least the past 5 years

- diagnosis of CP was based on the clinical and radiographic criteria proposed by the 1999 World Workshop for Classification of Periodontal Diseases and Conditions

Exclusion Criteria:

- pregnancy

- lactation

- current smoking or smoking within the past 2 years, periodontal therapy in the previous 6 months

- antibiotic and/or antimicrobial therapies in the previous 3 months

- existence of serious diabetic complications or any pathology such as haemoglobinopathy which would affect haemoglobin profile

- diagnosis of another major medical pathology, middle or upper-level obesity according to WHO classification

- current anti-hyperlipidemic therapy

- non-T2DM patients with abnormal values of glucose and lipid metabolism parameters, major medical pathology and family history of DM

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
Turkey Suleyman Demirel University Isparta

Sponsors (1)

Lead Sponsor Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c Level of Metabolic Control One Year No
Secondary Clinical Periodontal Status Periodontal indices evaluating clinical periodontal health status One Year No
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