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NCT03873935 Clinical Trial

Vitamin D in Periodontal and Cardiovascular Disease Progression

Vitamin D Deficiency Clinical Trial

Official title:
Evaluation of Vitamin D on Periodontal and Cardiovascular Diseases Progression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03873935
Other study ID # #17-09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2015
Est. completion date February 5, 2019

Study information
Verified date December 2022
Source University of Messina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of periodontitis (CP) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and periodontitis in patients with CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.

Description:

Using a cross-sectional design, a total of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will enrolled in the present study.

Recruitment information / eligibility
Status Completed
Enrollment 179
Est. completion date February 5, 2019
Est. primary completion date January 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 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

Related Conditions & MeSH terms

Intervention

Other:
• Evaluation of periodontal status
Clinical examination

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 Clinical Attachment level Clinical Analysis 1 year
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