Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Level

NCT ID: NCT02676362

Last Updated: 2016-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The mechanisms underlying the formation and composition of gingival crevicular fluid (GCF) and its flow into and from periodontal pockets are not understood very well. The aim of this study was to evaluate the length of sampling time and sequential sampling of GCF neutrophil elastase (NE) enzyme activity by using intracrevicular and orifice methods.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Twenty adults (mean age of 41.8 years. ranged 31-60 years. 18 males. 2 females) with chronic periodontitis were enrolled and all completed the 3-day study. Three-hundred-sixty samples of GCF were harvested from the interproximal sites of each of the two maxillary non-molar teeth according to the orifice method. Each site was sampled three times with 1-min intervals between repeat samples. By using intracrevicular method, the other 360 samples of GCF were collected on the same sites following 10-minutes interval. In first day, 2nd day and 3rd day the length of sampling time in seconds and order were 5. 10. 30; 10. 30. 5 and 30. 5. 10. respectively. GCF elastase activity was determined by hydrolysis of neutrophil specific substrate N-methoxysuccinyl-Ala-Ala-Pro-Val-p-nitroanilide and was expressed as concentration (microU/microl) and total enzyme activity (microU).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

the first day

Gingival crevicular fluid collection with filter paper the length of sampling time in seconds: 5., 10., 30.

Group Type EXPERIMENTAL

Gingival crevicular fluid collection with filter paper

Intervention Type OTHER

Gingival Crevicular Fluid Dynamics

the 2nd day

Gingival crevicular fluid collection with filter paper the length of sampling time in seconds: 10., 30., 5.

Group Type EXPERIMENTAL

Gingival crevicular fluid collection with filter paper

Intervention Type OTHER

Gingival Crevicular Fluid Dynamics

the 3rd day

Gingival crevicular fluid collection with filter paper the length of sampling time in second: 30., 5., 10.

Group Type EXPERIMENTAL

Gingival crevicular fluid collection with filter paper

Intervention Type OTHER

Gingival Crevicular Fluid Dynamics

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gingival crevicular fluid collection with filter paper

Gingival Crevicular Fluid Dynamics

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* no history of systemic disease;
* no history of antibiotics and/or anti-inflammatory drugs within the past 6 months;
* no received any oral hygiene prophylaxis and scaling and root planing within the past 6 months;
* at least 2 interproximal sites exhibiting higher than 5 mm probing depth, radiographic bone loss and gingival index of 2 (with preference of two maxillary non-molar teeth)

Exclusion Criteria

* with metabolic diseases
* pregnancy, lactation etc.
Minimum Eligible Age

31 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baskent University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nilgün Özlem Alptekin

Prof., DDS, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08/05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.