Clinical trial NCT01467674: The Effect Of Glycemic Control On Malondialdehyde, Glutathione Peroxidase, Glutathione And Paraoxonase
Official title: Malondialdehyde And Antioxidant Levels In Chronic Periodontitis Patients With Type 2 Diabetes Mellitus Under Different Stages Of Metabolic Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Chronic Periodontitis
Keywords: Diabetes mellitus
Chronic periodontitis
Malondialdehyde
Glutathione peroxidase
Paraoxonase
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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).

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 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

Primary outcomes:
measure: HbA1c
timeFrame: One Year
Secondary outcomes:
measure: Clinical Periodontal Status
timeFrame: One Year
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
Study officials:
affiliation: Professor, Periodontology Dept
name: F. Yeşim Kırzıoğlu, 1
role: STUDY_DIRECTOR
affiliation: Professor, Biophysics Dept
name: Mustafa Nazıroğlu, 1
role: STUDY_DIRECTOR
affiliation: Professor, Internal Diseases Dept.
name: M. Numan Tamer, 1
role: STUDY_DIRECTOR
References: