Back to resultsMethodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Level
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gingival crevicular fluid collection with filter paper
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Periodontitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
the first day
the 2nd day
the 3rd day
Arm Description
Gingival crevicular fluid collection with filter paper the length of sampling time in seconds: 5., 10., 30.
Gingival crevicular fluid collection with filter paper the length of sampling time in seconds: 10., 30., 5.
Gingival crevicular fluid collection with filter paper the length of sampling time in second: 30., 5., 10.
Outcomes
Primary Outcome Measures
The length of sampling time of GCF Elastase Levels
Secondary Outcome Measures
The length of sampling time of GCF Volume
The length of sequential sampling of GCF Volume
The length of sequential sampling of GCF Elastase Levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02676362
Brief Title
Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Level
Official Title
Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Levels: Sequential Sampling, Length of Sampling Time And Two Different Sampling Methods
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the first day
Arm Type
Experimental
Arm Description
Gingival crevicular fluid collection with filter paper the length of sampling time in seconds: 5., 10., 30.
Arm Title
the 2nd day
Arm Type
Experimental
Arm Description
Gingival crevicular fluid collection with filter paper the length of sampling time in seconds: 10., 30., 5.
Arm Title
the 3rd day
Arm Type
Experimental
Arm Description
Gingival crevicular fluid collection with filter paper the length of sampling time in second: 30., 5., 10.
Intervention Type
Other
Intervention Name(s)
Gingival crevicular fluid collection with filter paper
Intervention Description
Gingival Crevicular Fluid Dynamics
Primary Outcome Measure Information:
Title
The length of sampling time of GCF Elastase Levels
Time Frame
3 days
Secondary Outcome Measure Information:
Title
The length of sampling time of GCF Volume
Time Frame
3 days
Title
The length of sequential sampling of GCF Volume
Time Frame
3 days
Title
The length of sequential sampling of GCF Elastase Levels
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Level
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