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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02282800
Other study ID # PanineeyaMVIDS
Secondary ID
Status Completed
Phase N/A
First received October 31, 2014
Last updated October 31, 2014
Start date November 2010
Est. completion date December 2011

Study information

Verified date October 2014
Source Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Observational

Clinical Trial Summary

The study was to intended to visualize the nuclear localization of vitamin D receptor in oral tissues of aggressive periodontitis patients to better understand the potential for receptor in disease activity or progression.


Description:

Aggressive periodontitis (AgP) is an infectious disease of the periodontium which affects young adults, causing damage to the supporting apparatus of the teeth, leading to rapid bone resorption and tooth loss. Its clinical features have been shown to result from several genetic and environmental factors.

This has increased the interest to research those genetic host factors as they may provide useful risk markers, reveal important information regarding the pathogenesis and also identification of effective preventive agents that might help decrease the disease burden.

1,25-dihydroxyvitamin D3,apart from these traditional calcium-related actions, this active form is being increasingly recognized for its potent anti-proliferative, anti-differentiative and immunomodulatory activities.

The calcitriol activity is largely mediated by the vitamin D receptor (VDR) whose expression has been described in some tissues. VDR is localized in both the cytosol and nucleus and accumulates in the nucleus in response to 1,25,dihydroxyvitamin D3 binding.

Expression and nuclear activation of the VDR are necessary for the effects of vitamin D. Thus, alterations in the vitamin D pathway lead to disturbances in mineral metabolism. It may be hypothesized that the rapid bone loss which occurs in aggressive periodontitis patients may be due to decreased or absence of expression of Vitamin D receptor in the nucleus.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date December 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 24 Years to 32 Years
Eligibility Inclusion Criteria:

1. Generalized Aggressive periodontitis patients were onset of periodontal disease at <35yrs of age and atleast eight teeth with probing depth >6mm and radiographic evidence of alveolar bone loss, three of which were not first molar or incisor under test group.

2. Control group includes systemically and periodontally healthy individuals who is of same age as that of test group.

Exclusion Criteria

1. Subjects taking drugs for vitamin D or calcium

2. Subjects received periodontal therapy within previous year

3. Pregnant subjects

4. Smokers

5. Patients with systemic diseases -

Study Design

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


Related Conditions & MeSH terms


Intervention

Genetic:
Vitamin D receptor
50-100mg gingival tissue samples were collected from both test and control group for immunohistochemical staining to assess the number of vitamin D receptors in nucleus as well cytoplasm and also for RNA isolation to check the presence of VDR gene.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Outcome

Type Measure Description Time frame Safety issue
Primary Less nuclear receptors in aggressive periodontitis Immunohistochemical staining has been done for test group and control group tissue samples where less nuclear vitamin D receptors are found in aggressive periodontitis patients. 24hrs No
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