Chronic PeriodontitisNCT02676362
Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Level
A study testing Gingival crevicular fluid collection with filter paper in people with Chronic Periodontitis, run by Baskent University.
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… Read more about this study
- Who is it for?
- Ages 31 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Gingival crevicular fluid collection with filter paper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- with metabolic diseases
- pregnancy, lactation etc.
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Periodontitis
- Being tested
- Gingival crevicular fluid collection with filter paper
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival crevicular fluid collection with filter paperOther
Gingival Crevicular Fluid Dynamics
| Study group | Role | What they receive |
|---|---|---|
| the first day | Experimental | Gingival crevicular fluid collection with filter paper the length of sampling time in seconds: 5., 10., 30. Receives: 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. Receives: 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. Receives: Other: Gingival crevicular fluid collection with filter paper |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of sampling time of GCF Elastase Levels
Measured: 3 days
Secondary outcomes (3)
The length of sampling time of GCF Volume
Measured: 3 days
The length of sequential sampling of GCF Volume
Measured: 3 days
The length of sequential sampling of GCF Elastase Levels
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Özlem Alptekin, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676362
- Sponsor's protocol ID
- 08/05
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Levels: Sequential Sampling, Length of Sampling Time And Two Different Sampling Methods
- ClinicalTrials.gov ID
- NCT02676362
- Acronym / sponsor ID
- 08/05
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the first day | Experimental | Other: Gingival crevicular fluid collection with filter paperGingival crevicular fluid collection with filter paper the length of sampling time in seconds: 5., 10., 30. |
| the 2nd day | Experimental | Other: Gingival crevicular fluid collection with filter paperGingival crevicular fluid collection with filter paper the length of sampling time in seconds: 10., 30., 5. |
| the 3rd day | Experimental | Other: Gingival crevicular fluid collection with filter paperGingival crevicular fluid collection with filter paper the length of sampling time in second: 30., 5., 10. |
Who may qualify
- Ages
- 31 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- with metabolic diseases
- pregnancy, lactation etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingival crevicular fluid collection with filter paperGingival Crevicular Fluid Dynamics | Other | the 2nd day, the 3rd day, the first day |
Primary outcome
The length of sampling time of GCF Elastase Levels
Time frame: 3 days
3 secondary outcomes
The length of sampling time of GCF Volume
Time frame: 3 days
The length of sequential sampling of GCF Volume
Time frame: 3 days
The length of sequential sampling of GCF Elastase Levels
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival crevicular fluid collection with filter paper in people with Chronic Periodontitis, run by Baskent University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of sampling time of GCF Elastase Levels (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.