Immunolocalization of 1,25,Dihydroxyvitamin D3 in Aggressive Periodontitis Patients

NCT ID: NCT02282800

Last Updated: 2014-11-04

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

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-12-31

Brief Summary

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

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.

Detailed Description

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

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.

Conditions

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

Aggressive 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.

Case group

Case group include patients with generalized AgP were the tissue samples taken to analyse the number of vitamin D receptor present.

Vitamin D receptor

Intervention Type GENETIC

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.

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

Vitamin D receptor

Intervention Type GENETIC

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type GENETIC

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

1,25,dihydroxyvitamin D3 receptor

Eligibility Criteria

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

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 -
Minimum Eligible Age

24 Years

Maximum Eligible Age

32 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

OTHER

Sponsor Role lead

Responsible Party

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

Dr.Dasari Rajashre

Immunolocalization of 1,25,Dihydroxyvitamin D3 in Aggressive Periodontitis Patients

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Rajashree Dasari, MDS

Role: PRINCIPAL_INVESTIGATOR

Panineeya Mahavidyalaya

Other Identifiers

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

PanineeyaMVIDS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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