Chronic PeriodontitisNCT02127346
Relationship Between Chronic Periodontitis and Vitamin D and Calcium in Men
An observational study of Chronic Periodontitis, run by Damascus University at 1 site in Syria.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- How many people
- 200 participants
- Where
- 1 siteSyria
- Study dates
- May 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
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.
First group (Chronic Periodontitis) inclusion criteria:
- Male patients
- Patients are suffering from chronic periodontitis
- Patients do no have systemic diseases
- Patients should have 20 teeth at least
- 30 year old at least
Second group (Healthy Volunteers) inclusion criteria:
- Male individuals
- With no systemic diseases or periodontitis
- 30 year old at least
- 20 teeth at least for each participant
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Periodontics, University of Damascus Dental School
Damascus, Rif-dimashq Governorate, DM20AM18
About this study
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.
Read the 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.
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic Periodontitis, Vitamin D concentration, Calcium concentration
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Serum Vitamin D concentration
Measured: One time assessment, within 24 hours before delivering any treatment
Serum Calcium concentration
Measured: One time assessment, within 24 hours before delivering any treatment
Secondary outcomes (3)
Pocket Depth
Measured: One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.
Bleeding on Probing
Measured: One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.
Clinical Attachment Loss (CAL)
Measured: One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Alharissi, DDS MSc, Principal investigator, PhD student, Department of Periodontics, University of Damascus Dental School, DamascusSuleiman Dayoub, DDS MSc PhD, Study chair, Associate Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, DamascusRowaida Saymeh, DDS MSc PhD, Study director, Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127346
- Sponsor's protocol ID
- UDDS-Perio-04-2014
- Status last verified
- Oct 2015
- First submitted
- 25 Apr 2014
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8390053Crowle 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.
PubMed 3119492Dennison 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.
PubMed 9567966Jeffcoat 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.
PubMed 16277585Kinane 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.
PubMed 11155179Liu 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.
PubMed 16632602Ramanathan 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.
PubMed 11909747
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Chronic Periodontitis and Vitamin D and Calcium in Men
- ClinicalTrials.gov ID
- NCT02127346
- Acronym / sponsor ID
- UDDS-Perio-04-2014
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic Periodontitis, Vitamin D concentration, Calcium concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Vitamin D concentration
Time frame: 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
3 secondary outcomes
Pocket Depth
Time frame: 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.
Clinical Attachment Loss (CAL)
Time frame: One time assessment once sample recruitment has completed and within 24 hours before delivering any treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Background: PubMed 8390053Chapuy 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.
- Background: PubMed 3119492Crowle 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.
- Background: PubMed 9567966Dennison 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.
- Background: PubMed 16277585Jeffcoat 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.
- Background: PubMed 11155179Kinane 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.
- Background: PubMed 16632602Liu 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.
- Background: PubMed 11909747Ramanathan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Alharissi, DDS MSc principal investigator
PhD student, Department of Periodontics, University of Damascus Dental School, Damascus
Suleiman Dayoub, DDS MSc PhD study chair
Associate Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus
Rowaida Saymeh, DDS MSc PhD study director
Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Vitamin D concentration (time frame: One time assessment, within 24 hours before delivering any treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127346, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.