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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02615626
Other study ID # VLandPT
Secondary ID
Status Completed
Phase N/A
First received November 23, 2015
Last updated November 24, 2015
Start date May 2012
Est. completion date January 2014

Study information

Verified date November 2015
Source Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study was to evaluate visfatin levels in different stages of periodontal diseases and health, moreover the effect of non-surgical periodontal therapy on visfatin levels in Gingival Crevicular Fluid (GCF) and Serum.


Description:

Total of 45 patients were divided into three groups based on their clinical and radiographical examination. Group 1 chronic periodontitis (n: 15), group 2 plaque induced gingivitis (n: 15) and group 3 Periodontal health (n: 15). GCF and serum samples were collected before treatment and 1, 3, 6 months after treatment and were assayed using enzyme linked immunosorbent assay kit.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 2014
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 49 Years
Eligibility Group 1 Inclusion Criteria:

- GI>1, PPD=5mm, CAL=5mm with alveolar bone loss radiographically.

- Systematically healthy patients

Group 2 Inclusion Criteria:

- No alveolar bone and attachment loss

- Inflammation signs such as redness, edema and increased BOP levels,

- GI=2, PPD=3mm, CAL=3mm.

- Systematically healthy patients

Group 3 Inclusion Criteria:

- No bone and attachment loss,

- GI=0, PPD=3mm, CAL=3mm

- Systematically healthy patients

Exclusion Criteria for all groups:

- Aggressive Periodontitis,

- Oral pathologies,

- Patients with any other systemic diseases,

- Pregnant women and those in the lactation period,

- Patients with smoking habit and taking medication

- Patients received periodontal therapy in last 6 months

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Non-surgical Periodontal Treatment.
Non-surgical periodontal therapy is an anti-infective therapy which includes both mechanical and chemotherapeutic approaches to minimize or eliminate microbial biofilm, the primary etiology of gingivitis and periodontitis

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bulent Ecevit University

Outcome

Type Measure Description Time frame Safety issue
Primary Visfatin levels: Change after periodontal treatment both in serum and GCF baseline, 1, 3 and 6 months Yes
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