Aggressive PeriodontitisIVDAPNCT02282800
Immunolocalization of 1,25,Dihydroxyvitamin D3 in Aggressive Periodontitis Patients
An observational study of Aggressive Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
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. Read more about this study
- Who is it for?
- Ages 24 to 32 years
- Conditions the study is for
- Aggressive Periodontitis
- What is being tested?
- Vitamin D receptor
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Dec 2011
- 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 24 to 32 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population was divided in to two groups i.e test and control group
Who may be able to join
- 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.
- -
Who cannot join
- Subjects taking drugs for vitamin D or calcium
- Subjects received periodontal therapy within previous year
- Pregnant subjects
- Smokers
- Patients with systemic diseases -
About this study
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.
Read the 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.
- Conditions
- Aggressive Periodontitis
- Being tested
- Vitamin D receptor
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D receptorGenetic
Also called 1,25,dihydroxyvitamin D3 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.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Case group include patients with generalized AgP were the tissue samples taken to analyse the number of vitamin D receptor present. Receives: Genetic: Vitamin D receptor | |
| 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 Receives: Genetic: Vitamin D receptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startNov 2010
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Dasari Rajashre, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Rajashree Dasari, MDS, Principal investigator, Panineeya Mahavidyalaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282800
- Sponsor's protocol ID
- PanineeyaMVIDS
- Acronym
- IVDAP
- Status last verified
- Oct 2014
- First submitted
- 31 Oct 2014
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunolocalization of 1,25,Dihydroxyvitamin D3 in Aggressive Periodontitis Patients
- ClinicalTrials.gov ID
- NCT02282800
- Acronym / sponsor ID
- IVDAP / PanineeyaMVIDS
- Conditions
- Aggressive Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Nov 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.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Genetic: Vitamin D receptorCase group include patients with generalized AgP were the tissue samples taken to analyse the number of vitamin D receptor present. |
| Control group | – | Genetic: Vitamin D receptorEthnically 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 |
Who may qualify
- Ages
- 24 to 32 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population was divided in to two groups i.e test and control group
Key inclusion criteria (3 listed)
- 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.
- -
Key exclusion criteria (5 listed)
- Subjects taking drugs for vitamin D or calcium
- Subjects received periodontal therapy within previous year
- Pregnant subjects
- Smokers
- Patients with systemic diseases -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D receptorAlso: 1,25,dihydroxyvitamin D3 receptor50-100mg 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. | Genetic | Case group, Control group |
Primary outcome
Less nuclear receptors in aggressive periodontitis
Time frame: 24hrs
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.
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 4 Nov 2014.
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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.
Rajashree Dasari, MDS principal investigator
Panineeya Mahavidyalaya
Questions about this trial
What is this clinical trial studying?
An observational study of Aggressive Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Less nuclear receptors in aggressive periodontitis (time frame: 24hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2014.