Vitamin D in Systemic Sclerosis Patients With Periodontitis

NCT ID: NCT04066842

Last Updated: 2019-08-26

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

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-01

Study Completion Date

2019-05-30

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 Systemic Sclerosis (SSc) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and SSc and periodontitis in patients with SSc, 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 42 patients with SSc, 43 patients with CHD, 41 patients with both SSc and CP, and 42 healthy patients were enrolled in the present study.

Conditions

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Vitamin D Deficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1 - Controls

Control Healthy controls

Observation

Intervention Type OTHER

Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease

2 - SSc

SSc Systemic Sclerosis

Observation

Intervention Type OTHER

Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease

3 - Cardiovascular

Cardiovascular Cardiovascular disease

Observation

Intervention Type OTHER

Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease

4 - SSc+Periodontitis

SSc+ Periodontitis Systemic Sclerosis with Periodontitis

Observation

Intervention Type OTHER

Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease

Interventions

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Observation

Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease

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

20 Years

Maximum Eligible Age

75 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

Junior Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Locations

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University of Messina

Messina, , Italy

Site Status

Countries

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Italy

Other Identifiers

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10-918

Identifier Type: -

Identifier Source: org_study_id

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