Arterial Stiffness in Type 2 Diabetic Patients With Severe Periodontitis
Relationship Between Periodontal Status and Cardio Ankle Vascular Index in Short-term Type 2 Diabetic or Systemically Healthy Patients With or Without Severe Periodontitis
1 other identifier
observational
136
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2023
CompletedFirst Submitted
Initial submission to the registry
May 10, 2023
CompletedFirst Posted
Study publicly available on registry
May 19, 2023
CompletedMay 19, 2023
May 1, 2023
8 months
May 10, 2023
May 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
CAVI measurements
mean CAVI values (m/s) in each study groups
at baseline
Study Arms (4)
diabetes and periodontitis group (group 1)
35 subjects with type 2 diabetes and severe periodontitis were recruited in group 1. The clinical periodontal parameters taken are as follows: plaque index (PI), gingival index (GI), bleeding on brobing (BOP), probing depth (PD) and clinical attachment level (CAL). The present number of teeth in participants was recorded. Cardio-ankle vascular index (CAVI) was measured
diabetes and periodontally healthy (group 2)
34 subjects with type 2 diabetes and periodontally healthy were recruited in group 2. The clinical periodontal parameters taken are as follows: plaque index (PI), gingival index (GI), bleeding on brobing (BOP), probing depth (PD) and clinical attachment level (CAL). The present number of teeth in participants was recorded. Cardio-ankle vascular index (CAVI) was measured
systemically healthy and periodontitis (group 3)
32 systemically healthy subjects with severe periodontitis were recruited in group 3. The clinical periodontal parameters taken are as follows: plaque index (PI), gingival index (GI), bleeding on brobing (BOP), probing depth (PD) and clinical attachment level (CAL). The present number of teeth in participants was recorded. Cardio-ankle vascular index (CAVI) was measured
systemically healthy and periodontally healthy (group 4)
35 systemically and periodontally healthy subjects were recruited in group 4. The clinical periodontal parameters taken are as follows: plaque index (PI), gingival index (GI), bleeding on brobing (BOP), probing depth (PD) and clinical attachment level (CAL). The present number of teeth in participants was recorded. Cardio-ankle vascular index (CAVI) was measured
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- short-term type 2 diabetes mellitus diagnosis (\<5 years) or systemically healthy subjects
- patients with severe periodontitis or periodontally healthy subjects
You may not qualify if:
- had vascular diabetic complications
- hypertensive and dyslipidaemic/hyperlipidaemic patients
- Smokers and ex-smokers
- pregnancy and lactation
- using systemic antibiotic or anti-inflammatory drugs in the 6 months before the start of the study
- history of past periodontal treatment within 6 months period
- ankle-branchial index (ABI) values less than 0.9
- obesity with BMI ≥ 30 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University Faculty of Dentistry
Denizli, 20160, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gizem Torumtay Cin, PhD
Pamukkale University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
May 10, 2023
First Posted
May 19, 2023
Study Start
June 10, 2022
Primary Completion
January 21, 2023
Study Completion
January 21, 2023
Last Updated
May 19, 2023
Record last verified: 2023-05