- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04066842
Vitamin D in Systemic Sclerosis Patients With Periodontitis
Evaluation Of Vitamin D In Systemic Sclerosis Patients With Periodontitis: A Possible Role In Cardiovascular Disease Risk Progression?
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Messina, Italy, 98125
- University of Messina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1 - Controls
Control Healthy controls
|
Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease
|
2 - SSc
SSc Systemic Sclerosis
|
Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease
|
3 - Cardiovascular
Cardiovascular Cardiovascular disease
|
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
|
Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin D levels
Time Frame: 1 year
|
Evaluation of serum Vitamin D levels
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-918
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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