NCT02498938

Brief Summary

Chronic obstructive pulmonary disease and periodontitis are chronic inflammatory diseases. The study aims to determine if the genetic polymorphism of SERPINA1 gene in patients with COPD serve as a risk factor for developing periodontitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

July 13, 2015

Last Update Submit

August 26, 2016

Conditions

Pulmonary Disease, Chronic ObstructiveGeneralized Chronic Periodontitis

Keywords

Pulmonary disease,chronic obstructive,generalized chronic periodontitisSERPINA1 gene polymorphism

Outcome Measures

Primary Outcomes (1)

  • SERPINA1 gene polymorphism

    of blood samples and running samples by PCR

    9 months

Study Arms (1)

SERPINA1 gene in COPD and periodontitis

patients aged between 30-70 yrs with COPD (satisfying Gold's criteria) and chronic periodontitis (\>4mm pocket probing depth)

Genetic: SERPINA1 gene

Interventions

SERPINA1 geneGENETIC

2ml blood sample collected from patients to extract DNA for assessment of SERPINA1 gene polymorphism

Also known as: serine peptidase inhibitor, proteinase inhibitor
SERPINA1 gene in COPD and periodontitis

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients,both male and female aged between 30-70yrs with COPD nd chronic periodontitis

You may qualify if:

  • Male and female patients aged between 30-70yrs diagnosed with COPD and chronic periodontitis who are willing to participate in the study.

You may not qualify if:

  • Pateints with other systemic disorders
  • patients not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Sneha Agarwal PG(periodontics)

Hyderabad, Telangana, 500034, India

Location

Related Publications (2)

  • Scott DA, von Ahsen N, Palmer RM, Wilson RF. Analysis of two common alpha 1-antitrypsin deficiency alleles (PI*Z and PI*S) in subjects with periodontitis. J Clin Periodontol. 2002 Dec;29(12):1118-21. doi: 10.1034/j.1600-051x.2002.291212.x.

    PMID: 12492914BACKGROUND

  • Travis J, Pike R, Imamura T, Potempa J. The role of proteolytic enzymes in the development of pulmonary emphysema and periodontal disease. Am J Respir Crit Care Med. 1994 Dec;150(6 Pt 2):S143-6. doi: 10.1164/ajrccm/150.6_Pt_2.S143.

    PMID: 7952650BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

2ml of blood sample from each subject will be collected in EDTA containing vials and kept at -20 degrees until DNA extraction. the genomic DNA will be isolated and Z/S polumorphism in SERPINA1 gene will be identified by PCR followed by restriction digestion pattern by Alu 1 restriction enzyme.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

alpha 1-AntitrypsinHIV Protease Inhibitors

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesSerpinsPeptidesAmino Acids, Peptides, and ProteinsAcute-Phase ProteinsBlood ProteinsProteinsAlpha-GlobulinsSerum GlobulinsGlobulinsViral Protease InhibitorsProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAnti-HIV AgentsAnti-Retroviral AgentsAntiviral AgentsAnti-Infective AgentsTherapeutic Uses

Study Officials

  • Dr. Sneha Agarwal, PG(perio)

    Panineeya Mahavidyalaya institute of dental sciences and research centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
P.G student

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 15, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

August 29, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)