Generalized Chronic PeriodontitisCTROPNCT02273128
A Study to Assess the Disturbances in Calcitonin Gene in Patients With Gum Disease and Osteoporosis
An observational study of Generalized Chronic Periodontitis and Osteoporosis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Chronic Periodontitis, Osteoporosis
- What is being tested?
- CTR Gene
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2014to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients both male and female aged between 35-60 Years with Osteoporosis and Chronic Periodontitis.
Who may be able to join
- 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
Who cannot join
- Patients who are Systemically compromised and under medications such as steroids.
- Patients who smoke.Pregnant and lactating mothers are excluded from the study
Trial locations and contacts
1 site in 1 country.
India1 site
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
Hyderabad, Andhra Pradesh, 500060
About this study
Official title: Calcitonin Receptor Gene Polymorphisms in Patients With Osteoporosis and Chronic Periodontitis-An Observational Study
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.
Read the 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.
- Conditions
- Generalized Chronic Periodontitis, Osteoporosis
- Being tested
- CTR Gene
- Keywords
- Osteoporosis, Chronic Periodontitis, Calcitonin gene Polymorphism
- Medical subject headings
- Osteoporosis, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTR GeneGenetic
Also called Calcitonin Gene, Hypocalcaemic agent
2ml blood sample collected from patients to extract DNA for Assessment of CTR Gene polymorphism
| Study group | Role | What they receive |
|---|---|---|
| CTR Gene in Osteoporosis and Periodontitis | Patients aged between 35 - 60 yrs with Osteoporosis (BMD>-2.5) and Chronic Periodontitis (>3mm Pocket Probing Depth) Receives: Genetic: CTR Gene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcitonin gene polymorphism
Collection of blood samples and running the samples by PCR
Measured: 5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr,Anuradha Ankam, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Dr.Anuradha Ankam, PG(Perio), Principal investigator, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273128
- Sponsor's protocol ID
- D129206005
- Acronym
- CTROP
- Status last verified
- Apr 2015
- First submitted
- 21 Oct 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcitonin Receptor Gene Polymorphisms in Patients With Osteoporosis and Chronic Periodontitis-An Observational Study
- ClinicalTrials.gov ID
- NCT02273128
- Acronym / sponsor ID
- CTROP / D129206005
- Conditions
- Generalized Chronic Periodontitis, Osteoporosis
- Keywords
- Osteoporosis, Chronic Periodontitis, Calcitonin gene Polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTR Gene in Osteoporosis and Periodontitis | – | Genetic: CTR GenePatients aged between 35 - 60 yrs with Osteoporosis (BMD>-2.5) and Chronic Periodontitis (>3mm Pocket Probing Depth) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients both male and female aged between 35-60 Years with Osteoporosis and Chronic Periodontitis.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are Systemically compromised and under medications such as steroids.
- Patients who smoke.Pregnant and lactating mothers are excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTR GeneAlso: Calcitonin Gene, Hypocalcaemic agent2ml blood sample collected from patients to extract DNA for Assessment of CTR Gene polymorphism | Genetic | CTR Gene in Osteoporosis and Periodontitis |
Primary outcome
Calcitonin gene polymorphism
Time frame: 5 Months
Collection of blood samples and running the samples by PCR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
Related trials for Generalized Chronic Periodontitis
RecruitingPhase 2
3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV
Periodontitis Stage II, Periodontitis Stage III
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Anuradha Ankam, PG(Perio) principal investigator
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Chronic Periodontitis and Osteoporosis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcitonin gene polymorphism (time frame: 5 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.