Vitamin D in Periodontal and Cardiovascular Disease Progression

NCT03873935 | Completed DMC

• 1 other identifier: #17-09
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment level

  Clinical Analysis

  1 year

Study Arms (4)

Control

Healthy subjects

Other: Evaluation of periodontal status

Periodontitis

Patients with periodontal disease

Other: Evaluation of periodontal status

Cardiovascular

Patients with cardiovascular disease

Other: Evaluation of periodontal status

Periodontitis+Cardiovascular

People with both cardiovascular and periodontitis

Other: Evaluation of periodontal status

Interventions

Evaluation of periodontal status OTHER

Clinical examination

Cardiovascular; Control; Periodontitis; Periodontitis+Cardiovascular

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

University of Messina

Messina, 98125, Italy

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Gaetano Isola

  University of Messina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 14, 2019
• Study Start: January 2, 2015
• Primary Completion: January 5, 2018
• Study Completion: February 5, 2019
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: Pubmed website

Locations

IT (1)