NCT02127346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

April 25, 2014

Last Update Submit

October 2, 2015

Conditions

Keywords

Chronic PeriodontitisVitamin D concentrationCalcium concentration

Outcome Measures

Primary Outcomes (2)

  • Serum Vitamin D concentration

    One time assessment, within 24 hours before delivering any treatment

  • Serum Calcium concentration

    One time assessment, within 24 hours before delivering any treatment

Secondary Outcomes (3)

  • Pocket Depth

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

  • Bleeding on Probing

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

  • Clinical Attachment Loss (CAL)

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

Study Arms (2)

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

Eligibility Criteria

Age30 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Male patients
  • Patients are suffering from chronic periodontitis
  • Patients do no have systemic diseases
  • Patients should have 20 teeth at least
  • year old at least
  • Male individuals
  • With no systemic diseases or periodontitis
  • year old at least
  • teeth at least for each participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

Location

Related 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. No abstract available. French.

    PMID: 8390053BACKGROUND
  • 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.

    PMID: 3119492BACKGROUND
  • 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.

    PMID: 9567966BACKGROUND
  • 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.

    PMID: 16277585BACKGROUND
  • 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.

    PMID: 11155179BACKGROUND
  • 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.

    PMID: 16632602BACKGROUND
  • 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.

    PMID: 11909747BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammad Alharissi, DDS MSc

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

    PRINCIPAL INVESTIGATOR
  • Suleiman Dayoub, DDS MSc PhD

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

    STUDY CHAIR
  • Rowaida Saymeh, DDS MSc PhD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 30, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

October 5, 2015

Record last verified: 2015-10

Locations