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Completed

NCT Number: NCT04066842

Vitamin D in Systemic Sclerosis Patients With Periodontitis

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Messina

Messina, 98125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

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

Primary outcomes

  1. Vitamin D levels

    Time frame: 1 year

    Evaluation of serum Vitamin D levels

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2019
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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