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The Effect Of Glycemic Control On Malondialdehyde, Glutathione Peroxidase, Glutathione And Paraoxonase

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01467674
First Posted: November 9, 2011
Last Update Posted: November 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Yener ÖZAT, Suleyman Demirel University
  Purpose
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).

Condition
Type 2 Diabetes Mellitus Chronic Periodontitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Malondialdehyde And Antioxidant Levels In Chronic Periodontitis Patients With Type 2 Diabetes Mellitus Under Different Stages Of Metabolic Control

Further study details as provided by Dr. Yener ÖZAT, Suleyman Demirel University:

Primary Outcome Measures:
  • HbA1c [ Time Frame: One Year ]
    Level of Metabolic Control


Secondary Outcome Measures:
  • Clinical Periodontal Status [ Time Frame: One Year ]
    Periodontal indices evaluating clinical periodontal health status


Enrollment: 84
Study Start Date: January 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy
Chronic Periodontitis
Better Controlled T2DM
Poor Controlled T2DM

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with T2DM were recruited among those attending Suleyman Demirel University (SDU) Faculty of Medicine, Department of Endocrinology and non-diabetic individuals were recruited among those attending SDU Faculty of Dentistry, Department of Periodontology.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467674


Locations
Turkey
Suleyman Demirel University
Isparta, Turkey, 32260
Sponsors and Collaborators
Suleyman Demirel University
Investigators
Study Director: F. Yeşim Kırzıoğlu, 1 Professor, Periodontology Dept
Study Director: Mustafa Nazıroğlu, 1 Professor, Biophysics Dept
Study Director: M. Numan Tamer, 1 Professor, Internal Diseases Dept.
  More Information

Additional Information:
I  This link exits the ClinicalTrials.gov site

Responsible Party: Dr. Yener ÖZAT, Assistant Professor, Suleyman Demirel University
ClinicalTrials.gov Identifier: NCT01467674     History of Changes
Other Study ID Numbers: 1721-D-08
First Submitted: November 1, 2011
First Posted: November 9, 2011
Last Update Posted: November 9, 2011
Last Verified: November 2011

Keywords provided by Dr. Yener ÖZAT, Suleyman Demirel University:
Diabetes mellitus
Chronic periodontitis
Malondialdehyde
Glutathione peroxidase
Paraoxonase

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Periodontitis
Chronic Periodontitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases