The Association of SERPINA1 Gene Disturbance in Patients With Lung and Gum Disorders

Pulmonary Disease, Chronic Obstructive Clinical Trial

— SA1PLG  

Official title:

Evaluation of SERPINA1 Gene Polymorphisms in COPD as a Risk Factor for Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498938
• Other study ID #: D149206031
• 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

• Chronic Disease
• Chronic Periodontitis
• Generalized Chronic Periodontitis
• Lung Diseases
• Periodontitis
• Pulmonary Disease, Chronic Obstructive

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