Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Level

NCT02676362 | Completed DMC

• 1 other identifier: 08/05
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• The length of sampling time of GCF Elastase Levels

  3 days

Secondary Outcomes (3)

• 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

Study Arms (3)

the first day

EXPERIMENTAL

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

the 2nd day

EXPERIMENTAL

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

the 3rd day

EXPERIMENTAL

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

Interventions

Gingival crevicular fluid collection with filter paper OTHER

Gingival Crevicular Fluid Dynamics

the 2nd day; the 3rd day; the first day

Eligibility Criteria

• Age: 31 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• with metabolic diseases
• pregnancy, lactation etc.

Sponsors & Collaborators

• Baskent University: lead

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., DDS, PhD

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 8, 2016
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 9, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share