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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02423304
Other study ID # Divya Aiswairya thesis
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 17, 2015
Last updated April 21, 2015
Start date May 2015
Est. completion date June 2016

Study information

Verified date April 2015
Source Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Observational

Clinical 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 55 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Intervention

Genetic:
blood samples collected from all patients
blood samples collected from brachial pluxes

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre Research Institute for Genetic and Human Therapy

References & Publications (4)

Hernández Ríos M, Sorsa T, Obregón 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 a — View 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 Per — View 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. — View Citation

Uitto VJ, Airola K, Vaalamo M, Johansson N, Putnins EE, Firth JD, Salonen J, López-Otín C, Saarialho-Kere U, Kähäri VM. Collagenase-3 (matrix metalloproteinase-13) expression is induced in oral mucosal epithelium during chronic inflammation. Am J Pathol. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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Completed NCT01249846 - The Efficacy and Safety of 2.5 mg Chlorhexidine Gluconate Chip (PerioChip®) in Frequent Treatment Versus Routine Treatment in Therapy of Adult Chronic Periodontitis Phase 3