Coronary Heart DiseaseNCT05866497
Arterial Stiffness in Type 2 Diabetic Patients With Severe Periodontitis
An observational study of Coronary Heart Disease and Diabetes Mellitus, Type 2, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Diabetes Mellitus, Type 2, Periodontitis
- What is being tested?
- clinical periodontal measurements and CAVI measurements
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2022to 21 Jan 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- short-term type 2 diabetes mellitus diagnosis (<5 years) or systemically healthy subjects
- patients with severe periodontitis or periodontally healthy subjects
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Dentistry
Denizli, 20160
About this study
Official title: Relationship Between Periodontal Status and Cardio Ankle Vascular Index in Short-term Type 2 Diabetic or Systemically Healthy Patients With or Without Severe Periodontitis
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.
Read the 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.
- Being tested
- clinical periodontal measurements, CAVI measurements
- Medical subject headings
- Coronary Disease, Diabetes Mellitus, Type 2, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical periodontal measurementsDiagnostic test
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
CAVI measurementsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: clinical periodontal measurements; Diagnostic Test: CAVI measurements | |
| 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 Receives: Diagnostic Test: clinical periodontal measurements; Diagnostic Test: CAVI measurements | |
| 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 Receives: Diagnostic Test: clinical periodontal measurements; Diagnostic Test: CAVI measurements | |
| 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 Receives: Diagnostic Test: clinical periodontal measurements; Diagnostic Test: CAVI measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAVI measurements
mean CAVI values (m/s) in each study groups
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start10 Jun 2022
- Primary completion21 Jan 2023
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 136 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Torumtay Cin, Pamukkale University
- Investigators
- Gizem Torumtay Cin, PhD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866497
- Sponsor's protocol ID
- 07.06.2022/09
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Periodontal Status and Cardio Ankle Vascular Index in Short-term Type 2 Diabetic or Systemically Healthy Patients With or Without Severe Periodontitis
- ClinicalTrials.gov ID
- NCT05866497
- Acronym / sponsor ID
- 07.06.2022/09
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| diabetes and periodontitis group (group 1) | – | Diagnostic Test: clinical periodontal measurements, Diagnostic Test: CAVI measurements35 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) | – | Diagnostic Test: clinical periodontal measurements, Diagnostic Test: CAVI measurements34 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) | – | Diagnostic Test: clinical periodontal measurements, Diagnostic Test: CAVI measurements32 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) | – | Diagnostic Test: clinical periodontal measurements, Diagnostic Test: CAVI measurements35 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- short-term type 2 diabetes mellitus diagnosis (<5 years) or systemically healthy subjects
- patients with severe periodontitis or periodontally healthy subjects
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical periodontal measurementsPeriodontal 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 | Diagnostic test | diabetes and periodontally healthy (group 2), diabetes and periodontitis group (group 1), systemically healthy and periodontally healthy (group 4), systemically healthy and periodontitis (group 3) |
| CAVI measurementsArterial 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. | Diagnostic test | diabetes and periodontally healthy (group 2), diabetes and periodontitis group (group 1), systemically healthy and periodontally healthy (group 4), systemically healthy and periodontitis (group 3) |
Primary outcome
CAVI measurements
Time frame: at baseline
mean CAVI values (m/s) in each study groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Torumtay Cin, PhD principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Diabetes Mellitus, Type 2, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAVI measurements (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.