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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04030286
Other study ID # 16-12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2014
Est. completion date April 1, 2019

Study information

Verified date July 2019
Source University of Messina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Malondialdehyde (MDA) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (CHD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum MDA levels.


Description:

The aim of this study was to evaluate a possible association between both saliva and serum MDA levels in patients with CP and with CHD and if the serum MDA levels are mediated by serum CRP


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date April 1, 2019
Est. primary completion date September 9, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Presence of at least twenty 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


Intervention

Other:
Observation
Evaluation of Malondialdehyde level and correlation of Malondialdehyde level 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 Malondialdehyde levels 1 year
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