NCT02423304

Brief Summary

50 periodontitis 50 healthy individuals serological evaluation will done to see association of 77A/G AND 11A/12A gene polymorphisms of MMP-13

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

April 17, 2015

Last Update Submit

April 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Study Arms (2)

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.

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

Genetic: blood samples collected from all patients

Interventions

blood samples collected from brachial pluxes

controltest

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 19453573BACKGROUND
  • Uitto 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.

  • Kiili 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.

  • Hernandez 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.

Biospecimen

Retention: SAMPLES WITH DNA

blood serum

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr.M.Divya Aiswairya

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 22, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

April 22, 2015

Record last verified: 2015-04