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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02498938
Other study ID # D149206031
Secondary ID
Status Completed
Phase N/A
First received July 13, 2015
Last updated August 26, 2016
Start date March 2015
Est. completion date December 2015

Study information

Verified date August 2016
Source Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

periodontitis is a polymicrobial inflammatory disease caused by various modifiable and non-modifiable risk factors. the non-modifiable risk factors include genetic polymorphisms like the gene coding for alpha-1-antitrypsinase

COPD is a chronic inflammatory disease characterized by deterioration of lung function due to loss of elasticity of the lungs.

SERPINA1 gene product has a protective role on the connective tissue components of both lungs and gums.

Hence, this study tries to determine if the gene polymorphism in COPD serves as a risk factor for developing periodontitis.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Pateints with other systemic disorders

- patients not willing to participate in the study

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
India Dr. Sneha Agarwal PG(periodontics) Hyderabad Telangana

Sponsors (1)

Lead Sponsor Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Country where clinical trial is conducted

India, 

References & 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. — View Citation

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. Review. Erratum in: Am J Respir Crit Care Med 1995 Mar;151(3 Pt 1):926. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary SERPINA1 gene polymorphism of blood samples and running samples by PCR 9 months No
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