NCT02327533

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Status
completed

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

Study Start

First participant enrolled

February 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

1.6 years

First QC Date

December 17, 2014

Last Update Submit

December 24, 2014

Conditions

Keywords

generalized aggressive periodontitismicroarray analysis

Outcome Measures

Primary Outcomes (1)

  • mRNA quantification

    2 months

Secondary Outcomes (1)

  • Definition of gen networking and new molecular pathways

    2 months

Study Arms (2)

Patients with Aggressive Periodontitis

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)

Controls

Control subjects had no radiographic evidence of bone loss or any sign of past and present periodontitis.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Aggressive periodontitis patients: 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Kinane DF, Shiba H, Hart TC. The genetic basis of periodontitis. Periodontol 2000. 2005;39:91-117. doi: 10.1111/j.1600-0757.2005.00118.x. No abstract available.

    PMID: 16135066BACKGROUND
  • 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.

  • 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. doi: 10.1111/j.1600-0722.2004.00124.x.

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens were kept for analysis

Study Officials

  • Esra Güzeldemir-Akçakanat, DDS, PhD

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, PhD, Assoc. Prof.

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 30, 2014

Study Start

February 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12