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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04152005
Other study ID # 10-918-10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date September 30, 2018

Study information

Verified date November 2019
Source University of Messina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Recently, a key role played in the ethiology of periodontitis has been highlighted by a Endothelin (ET-1). ET1 possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. ET originate from bone marrow


Description:

The aim of the present study was to investigate the association between ET-1 in patients with periodontitis. Furthermore, the objective was to determine if the periodontal status influenced ET-1 levels.


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date September 30, 2018
Est. primary completion date September 25, 2018
Accepts healthy volunteers
Gender All
Age group 21 Years to 71 Years
Eligibility Inclusion Criteria:

- Presence of at least 16 teeth

- CP with a minimum of 40% of sites with a clinical attachment level (CAL)

=2mm and probing depth (PD) =4mm;

- Presence of at least =2 mm of crestal alveolar bone loss verified on digital periapical radiographs

- Presence of =40% sites with bleeding on probing (BOP)

Exclusion Criteria:

- Intake of contraceptives

- Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study

- Status of pregnancy or lactation

- Previous history of excessive drinking

- Allergy to local anaesthetic

- Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observation
Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease

Locations

Country Name City State
Italy University of Messina Messina

Sponsors (1)

Lead Sponsor Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of ET-1 levels Correlation of ET-1 levels with periodontal and cardiovascular disease 1 year
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