Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02327533
Other study ID # KOU KAEK2013/15
Secondary ID
Status Completed
Phase Early Phase 1
First received December 17, 2014
Last updated December 24, 2014
Start date February 2013
Est. completion date December 2014

Study information

Verified date December 2014
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, the investigators evaluated molecular biomarkers which play a role in the development of generalized aggressive periodontitis (GAgP) using gingival tissue samples through omics-based whole-genome transcriptomic while using healthy individuals as background controls.


Description:

Aggressive periodontitis (AgP) is an inflammatory periodontal disease which is complex, multifactorial, and destructive. Progression and severity of the disease depend on interacting risk factors such as: immunological, microbiological, environmental, and genetic factors, as well as age, sex, and race.Some patients are genetically predisposed to AgP; they have immunological abnormalities, which are thought to be under genetic control. However, high susceptibility for periodontal destruction and the relationship between inflammatory changes, and genetic factors remain unclear.

Gene expression profiling is a powerful means of generating comprehensive genome-level data sets on diseases such as cancer, asthma, rheumatoid disorders and periodontitis, and provides significant insight information for these diseases. Gene expression profiling may provide an evidence for involving genes in the pathogenesis of AgP and generate further information other than clinical signs and symptoms of AgP.

The aim of this study was to identify gene-expression patterns of patients with generalized aggressive periodontitis by whole-transcriptome gene-expression analyses.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999) Patients were included if they were between 18 and 35 years of age and otherwise healthy. The bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss.

Exclusion Criteria:

- Subjects were excluded if they had any known systemic diseases or conditions that can/could influence the periodontal status (cancer, cardiovascular and respiratory diseases), any history of hepatitis and/or HIV infection, immunosuppressive chemotherapy, current pregnancy, planning a pregnancy or lactation, requirement for antibiotic prophylaxis, oral diseases other than GAgP, ongoing orthodontic therapy, a history of antibiotic therapy, or periodontal treatment within the preceding six months.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

References & Publications (3)

Demmer RT, Behle JH, Wolf DL, Handfield M, Kebschull M, Celenti R, Pavlidis P, Papapanou PN. Transcriptomes in healthy and diseased gingival tissues. J Periodontol. 2008 Nov;79(11):2112-24. doi: 10.1902/jop.2008.080139 . — View Citation

Kinane DF, Shiba H, Hart TC. The genetic basis of periodontitis. Periodontol 2000. 2005;39:91-117. Review. — View Citation

Papapanou PN, Abron A, Verbitsky M, Picolos D, Yang J, Qin J, Fine JB, Pavlidis P. Gene expression signatures in chronic and aggressive periodontitis: a pilot study. Eur J Oral Sci. 2004 Jun;112(3):216-23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary mRNA quantification 2 months
Secondary Definition of gen networking and new molecular pathways 2 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04026828 - Evaluation of Possible Genes in Periodontal Diseases by Genetic Methods
Completed NCT03320135 - EMD for Treatment of Proximal Class-II Furcation Involvements N/A
Completed NCT02223702 - Alternative Antibiotic Regime in the Treatment of GAgP Phase 4
Completed NCT03512938 - Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis N/A
Completed NCT03642353 - Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families. Phase 4
Completed NCT03412331 - Effects Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis N/A
Completed NCT03933501 - Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment Phase 4
Completed NCT03225950 - Interaction Between Immune Cells and Bacteria Associated With Periodontitis
Completed NCT03933514 - Metagenomic and Immune-inflammatory Analysis of Individuals With Generalized Aggressive Periodontitis and Their Descendants.