Vitamin D in Systemic Sclerosis Patients With Periodontitis

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Other: Observation

• Registration Number: NCT04066842
• Lead Sponsor: 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 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

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.

Study Timeline

• Study Start: 2015-11-01
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-30
• Status Verified: 2019-08
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-22
• Study First Posted: 2019-08-26
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2 - SSc	Observation	SSc Systemic Sclerosis
1 - Controls	Observation	Control Healthy controls
3 - Cardiovascular	Observation	Cardiovascular Cardiovascular disease
4 - SSc+Periodontitis	Observation	SSc+ Periodontitis Systemic Sclerosis with Periodontitis

Primary Outcome Measures

Name	Time	Method
Vitamin D levels	1 year	Evaluation of serum Vitamin D levels

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy