Vitamin D in Periodontal and Cardiovascular Disease Progression

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Other: Evaluation of periodontal status

• Registration Number: NCT03873935
• Lead Sponsor: University of Messina

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.

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 Timeline

• Study Start: 2015-01-02
• Primary Completion: 2018-01-05
• Study Completion: 2019-02-05
• Study First Submitted: 2019-03-09
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Periodontitis+Cardiovascular	Evaluation of periodontal status	People with both cardiovascular and periodontitis
Control	Evaluation of periodontal status	Healthy subjects
Cardiovascular	Evaluation of periodontal status	Patients with cardiovascular disease
Periodontitis	Evaluation of periodontal status	Patients with periodontal disease

Primary Outcome Measures

Name	Time	Method
Clinical Attachment level	1 year	Clinical Analysis

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy