Relationship Between Chronic Periodontitis and Vitamin D and Calcium in Men

October 2, 2015 updated by: Damascus University
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Periodontics, University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients who are referred to the Periodontics Department at University of Damascus Dental School (Damascus, Syria) will be recruited in this research project. Healthy volunteers will be invited to participate in this research.

Description

First group (Chronic Periodontitis) inclusion criteria:

  1. Male patients
  2. Patients are suffering from chronic periodontitis
  3. Patients do no have systemic diseases
  4. Patients should have 20 teeth at least
  5. 30 year old at least

Second group (Healthy Volunteers) inclusion criteria:

  1. Male individuals
  2. With no systemic diseases or periodontitis
  3. 30 year old at least
  4. 20 teeth at least for each participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic Periodontitis
  1. Male patients
  2. Patients are suffering from chronic periodontitis
  3. Patients do not have any systemic diseases
  4. Subjects should have 20 teeth at least
  5. Age: 30 years or greater
Healthy Volunteers
  1. Males
  2. Healthy with no systemic diseases or periodontitis
  3. 30 years old at least
  4. 20 teeth are present at least

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Vitamin D concentration
Time Frame: One time assessment, within 24 hours before delivering any treatment
One time assessment, within 24 hours before delivering any treatment
Serum Calcium concentration
Time Frame: One time assessment, within 24 hours before delivering any treatment
One time assessment, within 24 hours before delivering any treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Pocket Depth
Time Frame: One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.
One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.
Bleeding on Probing
Time Frame: One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.
One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.
Clinical Attachment Loss (CAL)
Time Frame: One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.
One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Mohammad Alharissi, DDS MSc, PhD student, Department of Periodontics, University of Damascus Dental School, Damascus
  • Study Chair: Suleiman Dayoub, DDS MSc PhD, Associate Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus
  • Study Director: Rowaida Saymeh, DDS MSc PhD, Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Perio-04-2014

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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