Vitamin D in Periodontal and Cardiovascular Disease Progression

Evaluation of Vitamin D on Periodontal and Cardiovascular Diseases Progression

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Other: Evaluation of periodontal status

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98125
    • University of Messina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thus, for this study, at least of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will finally enrolled.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Healthy subjects	Other: Evaluation of periodontal status; Clinical examination
Periodontitis; Patients with periodontal disease	Other: Evaluation of periodontal status; Clinical examination
Cardiovascular; Patients with cardiovascular disease	Other: Evaluation of periodontal status; Clinical examination
Periodontitis+Cardiovascular; People with both cardiovascular and periodontitis	Other: Evaluation of periodontal status; Clinical examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment level	Clinical Analysis	1 year

Collaborators and Investigators

• Sponsor: University of Messina
• Investigators: Principal Investigator: Gaetano Isola, University of Messina

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2015
• Primary Completion (Actual): January 5, 2018
• Study Completion (Actual): February 5, 2019

Study Registration Dates

• First Submitted: March 9, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Cardiovascular Diseases; Disease Progression; Vitamin D Deficiency
• Other Study ID Numbers: #17-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: Pubmed website
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No