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Trial record 9 of 312 for:    "Periodontitis, Chronic"

Relationship Between Chronic Periodontitis and Vitamin D and Calcium in Men

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ClinicalTrials.gov Identifier: NCT02127346
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:
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.

Condition or disease
Chronic Periodontitis

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.


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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Relationship Between Chronic Periodontitis and Vitamin D and Calcium in Men
Study Start Date : May 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D
Drug Information available for: Vitamin D

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



Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127346


Locations
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Syrian Arab Republic
Department of Periodontics, University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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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:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02127346     History of Changes
Other Study ID Numbers: UDDS-Perio-04-2014
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015

Keywords provided by Damascus University:
Chronic Periodontitis
Vitamin D concentration
Calcium concentration

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Vitamin D
Ergocalciferols
Calcium, Dietary
Vitamins
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents