Vitamin D in Systemic Sclerosis Patients With Periodontitis

Vitamin D Deficiency Clinical Trial

Official title:

Evaluation Of Vitamin D In Systemic Sclerosis Patients With Periodontitis: A Possible Role In Cardiovascular Disease Risk Progression?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066842
• Other study ID #: 10-918
• Status: Completed
• Start date: November 1, 2015
• Est. completion date: May 30, 2019

Study information

• Verified date: August 2019
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: May 30, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Vitamin D Deficiency

Intervention

Other:
• Observation
Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease

Locations

Country	Name	City	State
Italy	University of Messina	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D levels	Evaluation of serum Vitamin D levels	1 year