- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02282800
Immunolocalization of 1,25,Dihydroxyvitamin D3 in Aggressive Periodontitis Patients (IVDAP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Control group includes systemically and periodontally healthy individuals who is of same age as that of test group.
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Exclusion Criteria
- Subjects taking drugs for vitamin D or calcium
- Subjects received periodontal therapy within previous year
- Pregnant subjects
- Smokers
- Patients with systemic diseases -
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Case group
Case group include patients with generalized AgP were the tissue samples taken to analyse the number of vitamin D receptor present.
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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.
Other Names:
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Control group
Ethnically matched, systemically and periodontally healthy individuals were included in control group were also gingival tissue taken for analysis of number of receptors present in nucleus and cytoplasm
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Less nuclear receptors in aggressive periodontitis
Time Frame: 24hrs
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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.
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24hrs
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Collaborators and Investigators
Investigators
- Principal Investigator: Rajashree Dasari, MDS, Panineeya Mahavidyalaya
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PanineeyaMVIDS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aggressive Periodontitis
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Asem Mohammed Kamel AliCompletedMolar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) | Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)Egypt
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University of Campinas, BrazilCompletedGeneralized Aggressive Periodontitis
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University of Campinas, BrazilCompletedGeneralized Aggressive Periodontitis
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