Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Level

Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Levels: Sequential Sampling, Length of Sampling Time And Two Different Sampling Methods

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Other: Gingival crevicular fluid collection with filter paper

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the first day; Gingival crevicular fluid collection with filter paper the length of sampling time in seconds: 5., 10., 30.	Other: Gingival crevicular fluid collection with filter paper; Gingival Crevicular Fluid Dynamics
Experimental: the 2nd day; Gingival crevicular fluid collection with filter paper the length of sampling time in seconds: 10., 30., 5.	Other: Gingival crevicular fluid collection with filter paper; Gingival Crevicular Fluid Dynamics
Experimental: the 3rd day; Gingival crevicular fluid collection with filter paper the length of sampling time in second: 30., 5., 10.	Other: Gingival crevicular fluid collection with filter paper; Gingival Crevicular Fluid Dynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The length of sampling time of GCF Elastase Levels	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The length of sampling time of GCF Volume	3 days
The length of sequential sampling of GCF Volume	3 days
The length of sequential sampling of GCF Elastase Levels	3 days

Collaborators and Investigators

• Sponsor: Baskent University

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: 08/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes