Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Level

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676362
• Other study ID #: 08/05
• Status: Completed
• Phase: N/A
• First received: February 1, 2016
• Last updated: February 8, 2016
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2016
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 31 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Other:
• Gingival crevicular fluid collection with filter paper
Gingival Crevicular Fluid Dynamics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The length of sampling time of GCF Elastase Levels		3 days	Yes
Secondary	The length of sampling time of GCF Volume		3 days	Yes
Secondary	The length of sequential sampling of GCF Volume		3 days	Yes
Secondary	The length of sequential sampling of GCF Elastase Levels		3 days	Yes