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A Study to Assess the Disturbances in Calcitonin Gene in Patients With Gum Disease and Osteoporosis (CTROP)

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ClinicalTrials.gov Identifier: NCT02273128
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Dr,Anuradha Ankam, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Brief Summary:
Osteoporosis and Periodontitis are multifactorial diseases which share common risk factors.The aim of the present study is to ellucidate polymorphisms in Calcitonin receptor gene? in patients with Osteoporosis and Periodontitis.

Condition or disease Intervention/treatment
Generalized Chronic Periodontitis Osteoporosis Genetic: CTR Gene

Detailed Description:

Periodontitis is a polymicrobial inflammatory disease which includes various modifiable and nonmodifiable risk factors. The non modifiable risk factors include genetic polymorphisms like metabolism associated genetic polymorphisms ( Vitamin D and Calcitonin).

Osteoporosis is a systemic skeletal disease characterized by low bone mass and micro-architectural deterioration of bone tissue with consequent increase in bone fragility and susceptibility to fractures.

Bone loss is a common feature shared between periodontal disease and osteoporosis.

Out of all genetic factors Calcitonin gene polymorphism contributes to the development of both osteoporosis and chronic periodontitis.


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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Calcitonin Receptor Gene Polymorphisms in Patients With Osteoporosis and Chronic Periodontitis-An Observational Study
Study Start Date : June 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CTR Gene in Osteoporosis and Periodontitis
Patients aged between 35 - 60 yrs with Osteoporosis (BMD>-2.5) and Chronic Periodontitis (>3mm Pocket Probing Depth)
Genetic: CTR Gene
2ml blood sample collected from patients to extract DNA for Assessment of CTR Gene polymorphism
Other Name: Calcitonin Gene, Hypocalcaemic agent




Primary Outcome Measures :
  1. Calcitonin gene polymorphism [ Time Frame: 5 Months ]
    Collection of blood samples and running the samples by PCR


Biospecimen Retention:   Samples With DNA
2ml of blood sample from each subject was collected in EDTA containing vials and kept at -20 degrees until DNA extraction. The genomic DNA was isolated and C/T polymorphism in CTR gene was identified by PCR followed by restriction digestion pattern by Alu 1 restriction enzyme.


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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients both male and female aged between 35-60 Years with Osteoporosis and Chronic Periodontitis.
Criteria

Inclusion Criteria:

  • Male and Female
  • Patients aged between 35.00 Year(s) to 60.00 Year(s) diagnosed with Osteoporosis and Chronic Periodontitis who are willing to participate in the study

Exclusion Criteria:

  • Patients who are Systemically compromised and under medications such as steroids.
  • Patients who smoke.Pregnant and lactating mothers are excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273128


Locations
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India
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
Hyderabad, Andhra Pradesh, India, 500060
Sponsors and Collaborators
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Investigators
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Principal Investigator: Dr.Anuradha Ankam, PG(Perio) Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

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Responsible Party: Dr,Anuradha Ankam, Post Graduate, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
ClinicalTrials.gov Identifier: NCT02273128     History of Changes
Other Study ID Numbers: D129206005
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Keywords provided by Dr,Anuradha Ankam, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre:
Osteoporosis
Chronic Periodontitis
Calcitonin gene Polymorphism
Additional relevant MeSH terms:
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Osteoporosis
Periodontitis
Chronic Periodontitis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
Katacalcin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents