Vitamin D in Periodontal and Cardiovascular Disease Progression

NCT ID: NCT03873935

Last Updated: 2022-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-02

Study Completion Date

2019-02-05

Brief Summary

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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

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Healthy subjects

Evaluation of periodontal status

Intervention Type OTHER

Clinical examination

Periodontitis

Patients with periodontal disease

Evaluation of periodontal status

Intervention Type OTHER

Clinical examination

Cardiovascular

Patients with cardiovascular disease

Evaluation of periodontal status

Intervention Type OTHER

Clinical examination

Periodontitis+Cardiovascular

People with both cardiovascular and periodontitis

Evaluation of periodontal status

Intervention Type OTHER

Clinical examination

Interventions

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Evaluation of periodontal status

Clinical examination

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Messina

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola, DDS, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

University of Messina

Locations

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University of Messina

Messina, , Italy

Site Status

Countries

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Italy

Other Identifiers

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#17-09

Identifier Type: -

Identifier Source: org_study_id

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