Arterial Stiffness in Type 2 Diabetic Patients With Severe Periodontitis
Condition: Coronary Heart Disease; Diabetes Mellitus, Type 2; Periodontitis; Arterial Stiffness
MeSH terms: Periodontitis; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus, Type 2
Study type: Observational [Patient Registry]

Summary: 
      Studies were found that a significant relationship between the severe periodontitis and
      increased CAVI values. While the exact mechanisms linking periodontitis, type 2 diabetes, and
      cardiovascular disease are not yet fully understood, it is clear that these diseases are
      interconnected. There are limited data in the literature evaluating the risk of
      atherosclerosis in diabetic individuals with periodontal disease. In our survey, we
      hypothesised that severe periodontitis may be a risk factor for the development of
      subclinical atherosclerosis among people with type 2 diabetes. Thus, we aimed to investigate
      the potential risk of subclinical atherosclerosis by using a new surrogate marker CAVI in
      severe periodontitis patients with short-term diabetes.
    

Detailed description: 
      Short-term diabetic subjects were selected from patients diagnosed with type 2 diabetes for
      less than 5 years recruited from those patients attending to the outpatient clinic at the
      Department of Endocrinology in University Hospital. Medical conditions of SH subjects were
      determined with detailed systemic examinations and biochemical analyses were performed in the
      Department of Endocrinology.

      The periodontal status of patients was determined based on the Classification of Periodontal
      and Peri-Implant Diseases and Conditions stated in 2017 World Workshop. Periodontally health
      was considered if the volunteers have clinically healthy gingiva on an intact periodontium
      who had BOP < 10% and PD ≤ 3 mm, no sites with attachment loss, no radiographic sign of
      alveolar bone destruction and no history of periodontitis. Patients with severe periodontitis
      were defined if they had interdental CAL ≥ 5 mm, PD ≥ 6 mm and radiographic bone loss
      extending to the mid-third of the root or beyond.

      Assessment of participants included in this study in terms of arterial stiffness was
      determined by CAVI index. Right and left CAVI values were calculated separately, and their
      mean value was used for the analysis. Besides the mean CAVI values, the CAVI values were
      categorized. CAVI ≥ 8 was considered conditionally pathological, while CAVI ≥ 9 was defined
      as pathologic.

      Various metabolic variables of the participants were collected at baseline to eliminate
      previously reported confounding factors as being associated with periodontitis and arterial
      stiffness. The body mass index (BMI) was calculated by taking the weight, in kilograms
      divided by the height in meters squared. BMI ≥ 25 kg/m2 was defined as overweight and BMI ≥
      30 kg/m2 as obese. Waist circumference (WC) was also recorded. Medical conditions were
      analysed by hematologic results. Glycated haemoglobin (HbA1c) and fasting plasma glucose
      (FPG) were assessed for the glycemic control levels of the participants. Also, dyslipidaemia
      and hyperlipidaemia were evaluated by the measurements of low-density lipoprotein (LDL),
      high-density lipoprotein (HDL), triglyceride (TRG) and total cholesterol (TK) levels.
      Systolic (SBP) and diastolic blood pressure (DBP) was measured and SBP ≥ 140 mmHg or DBP ≥ 90
      mmHg was defined as hypertension and excluded from the study population. C-reactive protein
      (CRP) levels of the participants were also evaluated at the beginning of the study.

      The power analyse of the study was performed for sample size calculation. Sample size was
      calculated using the G*Power software program (G*Power; Universitat, Dusseldorf, Germany) for
      α = 0.05 and f = 0.3. The analyses revealed that 32 subjects per group achieved a power of 80
      % with 95% confidence.

      The data were analysed with the SPSS 21 program (SPSS Inc., Chicago, IL). Continuous
      variables were presented as mean ± standard deviation and categorical variables as numbers
      and percentages. Shapiro-Wilk test was used to detect data's normality. For the comparison of
      the parameters of the study groups, One-way ANOVA test was used for normally distributed data
      while Kruskal-Wallis test was performed as non-parametric test. Chi-square test was used for
      the comparison of the categorical variables. Statistical significance value was considered as
      p < 0.05.
    

Intervention name(s): clinical periodontal measurements; CAVI measurements
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Periodontal parameters such as PI, GI, BOP, PD, and CAL were measured using the Williams periodontal probe (Hu-Friedy, Chicago IL). PD and CAL were calculated at six surfaces per tooth, whereas PI and GI were measured at four surfaces per tooth.
The periodontal status of patients was determined based on the Classification of Periodontal and Peri-Implant Diseases and Conditions stated in 2017 World Workshop; Arterial stiffness of the participants included in this study were assessed by CAVI index using VaSera (VS-1500N) CAVI device (Fukuda Denshi Co. Ltd., Tokyo, Japan) between both arms and ankles in a supine position.
Right and left CAVI values were calculated separately.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Type 2 diabetic subjects were selected from patients diagnosed with type 2 diabetes for
        less than 5 years recruited from those patients attending to the outpatient clinic at the
        Department of Endocrinology at Pamukkale University Hospital.

        Systemically healthy subjects were recruited from the patients who referred to Faculty of
        Dentistry in Pamukkale University for dental treatments. Medical conditions of systemically
        healthy subjects were determined with detailed systemic examinations and biochemical
        analyses were performed in the Department of Endocrinology at Pamukkale University
        Hospital.

        Patients with severe periodontitis or periodontally healthy subjects were selected from the
        patients who referred to the Periodontology Clinic in Faculty of Dentistry at Pamukkale
        University for periodontal examinations.