Relationship Between Chronic Periodontitis and Vitamin D and Calcium in Men

Chronic Periodontitis Clinical Trial

Official title:

Relationship Between Chronic Periodontitis and Vitamin D and Calcium in Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127346
• Other study ID #: UDDS-Perio-04-2014
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: October 2, 2015
• Start date: May 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Syria: Higher Education and Scientific Research Committee, University of Damascus
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Periodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

Chapuy MC, Meunier PJ. [Calcium and vitamin D3, a prevention of femoral neck fractures in elderly women]. Presse Med. 1993 Apr 10;22(13):615-6. French. — View Citation

Crowle AJ, Ross EJ, May MH. Inhibition by 1,25(OH)2-vitamin D3 of the multiplication of virulent tubercle bacilli in cultured human macrophages. Infect Immun. 1987 Dec;55(12):2945-50. — View Citation

Dennison DK, Van Dyke TE. The acute inflammatory response and the role of phagocytic cells in periodontal health and disease. Periodontol 2000. 1997 Jun;14:54-78. Review. — View Citation

Jeffcoat M. The association between osteoporosis and oral bone loss. J Periodontol. 2005 Nov;76(11 Suppl):2125-32. Review. — View Citation

Kinane DF. Causation and pathogenesis of periodontal disease. Periodontol 2000. 2001;25:8-20. Review. — View Citation

Liu H, Komai-Koma M, Xu D, Liew FY. Toll-like receptor 2 signaling modulates the functions of CD4+ CD25+ regulatory T cells. Proc Natl Acad Sci U S A. 2006 May 2;103(18):7048-53. Epub 2006 Apr 21. — View Citation

Ramanathan B, Davis EG, Ross CR, Blecha F. Cathelicidins: microbicidal activity, mechanisms of action, and roles in innate immunity. Microbes Infect. 2002 Mar;4(3):361-72. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Vitamin D concentration		One time assessment, within 24 hours before delivering any treatment	No
Primary	Serum Calcium concentration		One time assessment, within 24 hours before delivering any treatment	No
Secondary	Pocket Depth		One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.	No
Secondary	Bleeding on Probing		One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.	No
Secondary	Clinical Attachment Loss (CAL)		One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.	No