Generalized Adult PeriodontitisSEGPPAHNCT02423304
Serological Evaluation of 77A/G and 11A/12A Gene of MMP-13 in Periodontitis Affected and Healthy Individuals
An observational study of Generalized Adult Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
Trial summary
50 periodontitis 50 healthy individuals serological evaluation will done to see association of 77A/G AND 11A/12A gene polymorphisms of MMP-13 Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Adult Periodontitis
- What is being tested?
- blood samples collected from all patients
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jun 2016
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * The study will be conducted on 100 individuals * 50 chronic periodontitis and 50 healthy individuals will be recruited from the Out Patient Department of Periodontics in the study.
Who may be able to join
- Patients with chronic periodontitis classified according to American Academy of Periodontology ( AAP) 1999
- Subjects aged between 30-55 years
- Control group Systemically and periodontally healthy individuals of same age group
Who cannot join
- Present and past Smokers
- Presence of any systemic diseases.
- Oral diseases other than Periodontitis
- With a previous history of periodontal treatment in the past 6 months and subjects under any medications.
- Family history of any diagnosed genetic disorders.
About this study
Official title: A Serological Evaluation of 77A/G and 11A/12A Associated Gene Polymorphisms of MMP-13 in Periodontitis Affected and Healthy Individuals
50 periodontitis 50 healthy individuals serological evaluation will done to see association of 77A/G AND 11A/12A gene polymorphisms of MMP-13
Read the detailed description
- The study will be conducted on 100 individuals
- 50 chronic periodontitis and 50 healthy individuals will be recruited from the Out Patient Department of Periodontics in the study.
- An informed consent will be obtained from patients who wish to participate in the study.
- Patients will be categorized by Periodontal Disease Index (PDI) by P. Ramfjord(1959)
- After clinical examination, blood samples will be collected and assessed for MMP 13 Gene Polymorphisms.
- Subjects will be selected according to the study criteria and divided into two groups (50 each).
- Test group
- Control group
- Conditions
- Generalized Adult Periodontitis
- Being tested
- blood samples collected from all patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samples collected from all patientsGenetic
blood samples collected from brachial pluxes
| Study group | Role | What they receive |
|---|---|---|
| test | 50 periodontitis patients
• Patients will be categorized by Periodontal Disease Index (PDI) by P. Ramfjord(1959) blood samples collected from all patients serum separated and evaluated for77A/G AND 11A/12A associated gene polymorphism of Matrix Metallo Proteinase( MMP)-13 in all the patients. studies showing that there is co relation of these genes with increase inflammation. Receives: Genetic: blood samples collected from all patients | |
| control | 50 periodontally healthy individuals blood samples collected from all patients serum separated and evaluated for77A/G AND 11A/12A associated gene polymorphism of Matrix Metallo Proteinase (MMP)-13 in all the patients Receives: Genetic: blood samples collected from all patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the association of 77A/G AND 11A/12A gene polymorphism of mmp-13 in periodontitis effected and healthy individuals
collect DNA samples from serum and evaluate for gene polymorphism
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Generalized Adult 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Research Institute for Genetic and Human Therapy
- Responsible party
- Principal investigator, J.surya prasanna, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423304
- Sponsor's protocol ID
- Divya Aiswairya thesis
- Acronym
- SEGPPAH
- Status last verified
- Apr 2015
- First submitted
- 17 Apr 2015
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pirhan D, Atilla G, Emingil G, Tervahartiala T, Sorsa T, Berdeli A. MMP-13 promoter polymorphisms in patients with chronic periodontitis: effects on GCF MMP-13 levels and outcome of periodontal therapy. J Clin Periodontol. 2009 Jun;36(6):474-81. doi: 10.1111/j.1600-051X.2009.01399.x. Epub 2009 Apr 22.
PubMed 19453573Uitto VJ, Airola K, Vaalamo M, Johansson N, Putnins EE, Firth JD, Salonen J, Lopez-Otin C, Saarialho-Kere U, Kahari VM. Collagenase-3 (matrix metalloproteinase-13) expression is induced in oral mucosal epithelium during chronic inflammation. Am J Pathol. 1998 Jun;152(6):1489-99.
PubMed 9626053Kiili M, Cox SW, Chen HY, Wahlgren J, Maisi P, Eley BM, Salo T, Sorsa T. Collagenase-2 (MMP-8) and collagenase-3 (MMP-13) in adult periodontitis: molecular forms and levels in gingival crevicular fluid and immunolocalisation in gingival tissue. J Clin Periodontol. 2002 Mar;29(3):224-32. doi: 10.1034/j.1600-051x.2002.290308.x.
PubMed 11940142Hernandez Rios M, Sorsa T, Obregon F, Tervahartiala T, Valenzuela MA, Pozo P, Dutzan N, Lesaffre E, Molas M, Gamonal J. Proteolytic roles of matrix metalloproteinase (MMP)-13 during progression of chronic periodontitis: initial evidence for MMP-13/MMP-9 activation cascade. J Clin Periodontol. 2009 Dec;36(12):1011-7. doi: 10.1111/j.1600-051X.2009.01488.x.
PubMed 19929954
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Serological Evaluation of 77A/G and 11A/12A Associated Gene Polymorphisms of MMP-13 in Periodontitis Affected and Healthy Individuals
- ClinicalTrials.gov ID
- NCT02423304
- Acronym / sponsor ID
- SEGPPAH / Divya Aiswairya thesis
- Conditions
- Generalized Adult Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Collaborators
- Research Institute for Genetic and Human Therapy
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 22 Apr 2015 (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.
50 periodontitis 50 healthy individuals serological evaluation will done to see association of 77A/G AND 11A/12A gene polymorphisms of MMP-13
Detailed description
- The study will be conducted on 100 individuals
- 50 chronic periodontitis and 50 healthy individuals will be recruited from the Out Patient Department of Periodontics in the study.
- An informed consent will be obtained from patients who wish to participate in the study.
- Patients will be categorized by Periodontal Disease Index (PDI) by P. Ramfjord(1959)
- After clinical examination, blood samples will be collected and assessed for MMP 13 Gene Polymorphisms.
- Subjects will be selected according to the study criteria and divided into two groups (50 each).
- Test group
- Control group
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test | – | Genetic: blood samples collected from all patients50 periodontitis patients • Patients will be categorized by Periodontal Disease Index (PDI) by P. Ramfjord(1959) blood samples collected from all patients serum separated and evaluated for77A/G AND 11A/12A associated gene polymorphism of Matrix Metallo Proteinase( MMP)-13 in all the patients. studies showing that there is co relation of these genes with increase inflammation. |
| control | – | Genetic: blood samples collected from all patients50 periodontally healthy individuals blood samples collected from all patients serum separated and evaluated for77A/G AND 11A/12A associated gene polymorphism of Matrix Metallo Proteinase (MMP)-13 in all the patients |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * The study will be conducted on 100 individuals * 50 chronic periodontitis and 50 healthy individuals will be recruited from the Out Patient Department of Periodontics in the study.
Key inclusion criteria (3 listed)
- Patients with chronic periodontitis classified according to American Academy of Periodontology ( AAP) 1999
- Subjects aged between 30-55 years
Key exclusion criteria (5 listed)
- Present and past Smokers
- Presence of any systemic diseases.
- Oral diseases other than Periodontitis
- With a previous history of periodontal treatment in the past 6 months and subjects under any medications.
- Family history of any diagnosed genetic disorders.
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 |
|---|---|---|
| blood samples collected from all patientsblood samples collected from brachial pluxes | Genetic | control, test |
Primary outcome
to evaluate the association of 77A/G AND 11A/12A gene polymorphism of mmp-13 in periodontitis effected and healthy individuals
Time frame: 6 months
collect DNA samples from serum and evaluate for gene polymorphism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Background: PubMed 19453573Pirhan D, Atilla G, Emingil G, Tervahartiala T, Sorsa T, Berdeli A. MMP-13 promoter polymorphisms in patients with chronic periodontitis: effects on GCF MMP-13 levels and outcome of periodontal therapy. J Clin Periodontol. 2009 Jun;36(6):474-81. doi: 10.1111/j.1600-051X.2009.01399.x. Epub 2009 Apr 22.
- Results publication: PubMed 9626053Uitto VJ, Airola K, Vaalamo M, Johansson N, Putnins EE, Firth JD, Salonen J, Lopez-Otin C, Saarialho-Kere U, Kahari VM. Collagenase-3 (matrix metalloproteinase-13) expression is induced in oral mucosal epithelium during chronic inflammation. Am J Pathol. 1998 Jun;152(6):1489-99.
- Results publication: PubMed 11940142Kiili M, Cox SW, Chen HY, Wahlgren J, Maisi P, Eley BM, Salo T, Sorsa T. Collagenase-2 (MMP-8) and collagenase-3 (MMP-13) in adult periodontitis: molecular forms and levels in gingival crevicular fluid and immunolocalisation in gingival tissue. J Clin Periodontol. 2002 Mar;29(3):224-32. doi: 10.1034/j.1600-051x.2002.290308.x.
- Results publication: PubMed 19929954Hernandez Rios M, Sorsa T, Obregon F, Tervahartiala T, Valenzuela MA, Pozo P, Dutzan N, Lesaffre E, Molas M, Gamonal J. Proteolytic roles of matrix metalloproteinase (MMP)-13 during progression of chronic periodontitis: initial evidence for MMP-13/MMP-9 activation cascade. J Clin Periodontol. 2009 Dec;36(12):1011-7. doi: 10.1111/j.1600-051X.2009.01488.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Adult Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
to evaluate the association of 77A/G AND 11A/12A gene polymorphism of mmp-13 in periodontitis effected and healthy individuals (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02423304, which also lists 4 linked publications.
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 22 Apr 2015.