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Completed

NCT Number: NCT02127346

Relationship Between Chronic Periodontitis and Vitamin D and Calcium in Men

Objective: The objective was to evaluate whether serum vitamin D and calcium concentrations are associated with chronic periodontitis in Syrian men Methods: This study designed as "Matched Case-Control Study".200 males will be enrolled in this study and will be divided into two groups. First group consist of 100 patients suffering from chronic periodontitis and no systemic diseases. Second group consist of 100 healthy volunteers. Serum vitamin D and calcium concentrations will be tested. Periodontal indexes include probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) will be taken. Data will be collected and analyzed.

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Key information

Age range

30 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Periodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

About this study

Periodontal disease including chronic periodontitis results from interaction between pathogens and the host inflammatory response. This interaction triggers a complex process of inflammatory events, which in turn promote connective tissue destruction and alveolar bone remodeling. Periodontitis is described as a multifactorial irreversible and cumulative condition, initiated and propagated by bacteria and host factors.

Vitamin D and calcium are fundamental for bone mineralization and for the prevention of osteoporosis Severe vitamin D deficiency lead to mineralization defects but chronically low intake of vitamin D and calcium leads to bade calcium balance and bone loss, and it is reasonable to expect this effect to occur in alveolar bone as it does in other bones of the body. A study has showed a positive association between low bone mass or osteoporosis and alveolar bone loss and tooth loss.

Vitamin D serum concentrations might affect periodontal disease both through an effect on bone mineral density (BMD) and through immunomodulatory effects. Vitamin D is well established as being essential for bone growth and preservation. A potential anti-inflammatory effect of vitamin D is supported by an increasing amount of literature. The active metabolite of 25-hydroxyvitamin D, 1,25dihydroxyvitamin D, has been found to inhibit cytokine production and cell proliferation.

Low serum levels of vitamin D have been linked with a loss of periodontal attachment. Data from over 11,000 subjects were analyzed for serum vitamin D levels and attachment loss. In subjects less than 50 years of age, there was no significant association reported between vitamin D levels and attachment loss. In patients 50 years or older, serum vitamin D levels were inversely associated with attachment loss for men and women. It was concluded that the increased risk for periodontal disease might be attributable to low levels of vitamin D, which would reduce bone mineral density, or to an immunomodulatory effect.

In van der Putten et al study, based on the literature available to date, the association of vitamin D, and calcium deficiencies with periodontal disease in elderly people is essentially still unknown and not well researched. To produce conclusive evidence on the subject of this systematic literature review, longitudinal cohort studies and follow-up randomized controlled trials are needed

The aim of this study is to explore chronic periodontitis status and serum vitamin D and calcium concentrations in Syrian males and compare these figures with matched healthy volunteers with no periodontitis.

Who can participate

Healthy volunteers accepted: Yes

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

First group (Chronic Periodontitis) inclusion criteria:

  • Male patients
  • Patients are suffering from chronic periodontitis
  • Patients do no have systemic diseases
  • Patients should have 20 teeth at least
  • 30 year old at least

Second group (Healthy Volunteers) inclusion criteria:

  • Male individuals
  • With no systemic diseases or periodontitis
  • 30 year old at least
  • 20 teeth at least for each participant

Treatment and study plan

Primary outcomes

  1. Serum Vitamin D concentration

    Time frame: One time assessment, within 24 hours before delivering any treatment

  2. Serum Calcium concentration

    Time frame: One time assessment, within 24 hours before delivering any treatment

Secondary outcomes

  1. Pocket Depth

    Time frame: One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.

  2. Bleeding on Probing

    Time frame: One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.

  3. Clinical Attachment Loss (CAL)

    Time frame: One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 30, 2014
Registry last updated
Oct 5, 2015

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

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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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