Relationship Between Chronic Periodontitis and Vitamin D and Calcium in Men

NCT ID: NCT02127346

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


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

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Damascus University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohammad Alharissi, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

PhD student, Department of Periodontics, University of Damascus Dental School, Damascus

Suleiman Dayoub, DDS MSc PhD

Role: STUDY_CHAIR

Associate Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus

Rowaida Saymeh, DDS MSc PhD

Role: STUDY_DIRECTOR

Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Periodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, Syria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Syria

References

Explore related publications, articles, or registry entries linked to this study.

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. No abstract available. French.

Reference Type BACKGROUND
PMID: 8390053 (View on PubMed)

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. doi: 10.1128/iai.55.12.2945-2950.1987.

Reference Type BACKGROUND
PMID: 3119492 (View on PubMed)

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. doi: 10.1111/j.1600-0757.1997.tb00192.x. No abstract available.

Reference Type BACKGROUND
PMID: 9567966 (View on PubMed)

Jeffcoat M. The association between osteoporosis and oral bone loss. J Periodontol. 2005 Nov;76(11 Suppl):2125-32. doi: 10.1902/jop.2005.76.11-S.2125.

Reference Type BACKGROUND
PMID: 16277585 (View on PubMed)

Kinane DF. Causation and pathogenesis of periodontal disease. Periodontol 2000. 2001;25:8-20. doi: 10.1034/j.1600-0757.2001.22250102.x. No abstract available.

Reference Type BACKGROUND
PMID: 11155179 (View on PubMed)

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. doi: 10.1073/pnas.0601554103. Epub 2006 Apr 21.

Reference Type BACKGROUND
PMID: 16632602 (View on PubMed)

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. doi: 10.1016/s1286-4579(02)01549-6.

Reference Type BACKGROUND
PMID: 11909747 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UDDS-Perio-04-2014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.