Clinical trial NCT02423304: Serological Evaluation of 77A/G and 11A/12A Gene of MMP-13 in Periodontitis Affected and Healthy Individuals
Official title: A Serological Evaluation of 77A/G and 11A/12A Associated Gene Polymorphisms of MMP-13 in Periodontitis Affected and Healthy Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Generalized Adult Periodontitis
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
Collaborators: name: Research Institute for Genetic and Human Therapy
First posted: 2015-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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

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).

  1. Test group
  2. Control group

Eligibility criteria: Inclusion Criteria:• Test group

1. Patients with chronic periodontitis classified according to American Academy of Periodontology ( AAP) 1999
2. Subjects aged between 30-55 years

   * Control group Systemically and periodontally healthy individuals of same age group

Exclusion Criteria:

1. Present and past Smokers
2. Presence of any systemic diseases.
3. Oral diseases other than Periodontitis
4. With a previous history of periodontal treatment in the past 6 months and subjects under any medications.
5. Family history of any diagnosed genetic disorders.

Primary outcomes:
measure: to evaluate the association of 77A/G AND 11A/12A gene polymorphism of mmp-13 in periodontitis effected and healthy individuals
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.