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Vitamin D in Periodontal and Cardiovascular Disease Progression

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ClinicalTrials.gov Identifier: NCT03873935
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Gaetano Isola, DDS, PhD, 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.

Condition or disease Intervention/treatment
Vitamin D Deficiency 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.

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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 : January 2, 2015
Actual Primary Completion Date : January 5, 2018
Actual Study Completion Date : February 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. Clinical Attachment level [ Time Frame: 1 year ]
    Clinical Analysis



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873935


Locations
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Italy
University of Messina
Messina, Italy, 98125
Sponsors and Collaborators
University of Messina
Investigators
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Principal Investigator: Gaetano Isola University of Messina

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Responsible Party: Gaetano Isola, DDS, PhD, Principal Investigator, University of Messina
ClinicalTrials.gov Identifier: NCT03873935     History of Changes
Other Study ID Numbers: #17-09
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: 1 year
Access Criteria: Pubmed website

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D Deficiency
Disease Progression
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents