NCT02282800

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
Last Updated

November 4, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

October 31, 2014

Last Update Submit

October 31, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Case group

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

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

Genetic: Vitamin D receptor

Interventions

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.

Also known as: 1,25,dihydroxyvitamin D3 receptor
Case groupControl group

Eligibility Criteria

Age24 Years - 32 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population was divided in to two groups i.e test and control group

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects taking drugs for vitamin D or calcium
  • Subjects received periodontal therapy within previous year
  • Pregnant subjects
  • Smokers
  • Patients with systemic diseases -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

Receptors, Calcitriol

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Receptors, Cytoplasmic and NuclearProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Rajashree Dasari, MDS

    Panineeya Mahavidyalaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Immunolocalization of 1,25,Dihydroxyvitamin D3 in Aggressive Periodontitis Patients

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 4, 2014

Study Start

November 1, 2010

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

November 4, 2014

Record last verified: 2014-10