The impact of gum disease on the levels of a cardiovascular disease marker in the body
| ISRCTN | ISRCTN13626790 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13626790 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Bari Aldo Moro |
| Funder | Investigator initiated and funded |
- Submission date
- 21/06/2022
- Registration date
- 08/07/2022
- Last edited
- 16/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The endothelium is a thin membrane that lines the inside of the heart and blood vessels. Endothelial dysfunction is one of the early events in atherosclerosis (the thickening or hardening of the heart arteries). Severe gum disease (periodontitis) is considered to be a contributing risk factor for endothelial dysfunction. High blood concentration of a marker protein called asymmetric dimethylarginine (ADMA), has emerged as a predictor of the risk of cardiovascular disease. Thus, reducing periodontal inflammation might have clinical relevance in cardiovascular disease. Insufficient clinical evidence exists to draw clear conclusions regarding the long-term effects of periodontal disease on endothelial function, and even less evidence is available on ADMA concentration and its relationship with periodontitis. The aim of this study was to evaluate the effects of intensive periodontal treatment in modulating endothelial function via the assessment of plasma ADMA concentration in patients diagnosed with severe periodontitis.
Who can participate?
Adult patients diagnosed with generalized periodontitis
What does the study involve?
In this 6-month study, all patients will undergo a complete medical and clinical periodontal examination, laboratory analysis of ADMA, and ultrasound assessment of fibromuscular dysplasia (FMD) of the right brachial artery. After the screening, patients were randomly assigned to receive Intensive Periodontal Treatment or Community-based Periodontal Care. A full examination was carried out at baseline, 3 and 6 months after periodontal treatment.
What are the possible benefits and risks of participating?
There are no risks of participating. Benefits are related to the potential improvement of cardiovascular markers.
Where is the study run from?
University of Bari Aldo Moro (Italy)
When is the study starting and how long is it expected to run for?
July 2017 to October 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Biagio Rapone (Italy)
biagio.rapone@uniba.it
Contact information
Principal investigator
Interdisciplinary Department of Medicine
University of Bari Aldo Moro
Bari
60124
Italy
| Phone | +39 3477619817 |
|---|---|
| biagiorapone79@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center single-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The impact of periodontal inflammation on endothelial function assessed by circulating levels of asymmetric dimethylarginine: a single-blinded randomized clinical trial |
| Study acronym | P.I.ADMA |
| Study objectives | Periodontal treatment reduces the concentrations of asymmetric dimethylarginine in patients with a high risk of endothelial dysfunction |
| Ethics approval(s) | Approved 16/01/2018, Albania University Ethics Committee (Albanian University, Rr ‘Durresit”, Tirane 1001, Albania; +355 (0)686086880; e.quorri@albanianuniversity.edu.al), ref: Nr. 16 |
| Health condition(s) or problem(s) studied | Generalized periodontitis with no risk for endothelial dysfunction |
| Intervention | This was a 6-month, randomized controlled trial, including 140 patients between 41 and 63 years old, diagnosed with severe periodontitis, free from cardiovascular disease (CVD), and traditional cardiovascular risk factors. All patients underwent complete medical and clinical periodontal examination, laboratory analysis of ADMA, and ultrasound assessment of fibromuscular dysplasia (FMD) of the right brachial artery. After the screening, they were randomly assigned to receive intensive periodontal treatment (test group, n = 70) or community-based periodontal care (control group, n = 70). A full examination was carried out at baseline, 3 and 6 months after periodontal treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Asymmetric dimethylarginine levels in blood measured by enzyme-linked immunosorbent assay (ELISA, DLD Diagnostika, Hamburg, Germany) at baseline, 3 and 6 months |
| Key secondary outcome measure(s) |
1. Fibromuscular dysplasia (FMD) of the right brachial artery measured using ultrasound at baseline, 3 and 6 months |
| Completion date | 10/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 140 |
| Total final enrolment | 140 |
| Key inclusion criteria | 1. Aged between 41 years old and 63 years old 2. Diagnosis of generalized periodontitis |
| Key exclusion criteria | 1. Patients presenting with dental implants, orthodontic bands and ulcers 2. Patients who received periodontal treatment within 12 months prior to the start of the study 3. Patients who received systemic antibiotics within the last 6 months 4. Pregnancy or breastfeeding mothers 5. History of diabetes or a fasting glucose level greater than 126 mg/dl 6. History of cardiovascular disease 7. Patients with any systemic disease: 7.1. Diabetes mellitus 7.2. Cardiovascular disease 7.3. Kidney disease 7.4. Liver disease 7.5. Lung disease 8. Patients with cardiovascular risk factors and active smokers were excluded to minimize any confounding effect of conditions that may influence endothelial function |
| Date of first enrolment | 06/06/2018 |
| Date of final enrolment | 07/12/2018 |
Locations
Countries of recruitment
- Albania
Study participating centre
Tirane
1001
Albania
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the risk of improper use. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/07/2022 | 16/01/2023 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/01/2023: Publication reference added.
08/07/2022: Trial's existence confirmed by the Albania University Ethics Committee.
