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Vitamin D in Periodontal and Cardiovascular Disease Progression

Sponsor
University of Messina (Other)
Overall Status
Completed
CT.gov ID
NCT03873935
Collaborator
(none)
179
Enrollment
1
Location
49.1
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
179 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Vitamin D on Periodontal and Cardiovascular Diseases Progression
Actual Study Start Date :
Jan 2, 2015
Actual Primary Completion Date :
Jan 5, 2018
Actual Study Completion Date :
Feb 5, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Clinical Attachment level [1 year]

    Clinical Analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Messina Messina Italy 98125

Sponsors and Collaborators

  • University of Messina

Investigators

  • Principal Investigator: Gaetano Isola, University of Messina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gaetano Isola, DDS, PhD, Principal Investigator, University of Messina
ClinicalTrials.gov Identifier:
NCT03873935
Other Study ID Numbers:
  • #17-09
First Posted:
Mar 14, 2019
Last Update Posted:
Jun 27, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases
Vitamin D Deficiency
Disease Progression

Study Results

No Results Posted as of Jun 27, 2019