- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03009942
Biochemical Mediators After Implant Loading
January 2, 2017 updated by: Nurdan Ozmeric, Gazi University
Nitric Oxide and Arginase Levels in Peri-Implant Tissues After Delayed Loading
This study evaluates the nitric oxide and arginase levels in patients with dental implants.
Peri-implant sulcular fluid and saliva samples were collected after loading of the implants
Study Overview
Status
Completed
Conditions
Detailed Description
Nitric oxide (NO) metabolism is associated with the clinical inflammatory state of peri-implant tissues and also affected by the mechanic stimulus.
Therefore, The NO content of PISF reflects two different measures and can serve as an indicator of peri-implant soft tissue inflammation and/or bone response to force application and loading Arginase may reduce NO production by depleting the common substrate.
Thus, increased salivary arginase activities detected in periodontitis patients may cause decreased NO synthesis and lead to a decrease in the antibacterial property of saliva.
Study Type
Observational
Enrollment (Actual)
20
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Twenty patients with one or more implants restored with fixed crown prostheses
Description
Inclusion Criteria:
- Patients with ≥ 20 teeth, no systemic diseases that could affect bone metabolism, no smoking habits, and had one or more implants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemical parameters (nitric oxide and arginase) in periimplant sulcular fluid and saliva
Time Frame: Baseline and 1, 3 and 6 months after implant loading
|
The changes in nitric oxide and arginase levels after implant loading were determined.
|
Baseline and 1, 3 and 6 months after implant loading
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque index
Time Frame: Baseline and 1, 3 and 6 months after implant loading
|
The changes in plaque index after implant loading.
Plaque index was recorded for determining and classifying oral hygiene status.
|
Baseline and 1, 3 and 6 months after implant loading
|
|
Gingival index
Time Frame: Baseline and 1, 3 and 6 months after implant loading
|
The changes in gingival index after implant loading.
Gingival index was recorded for classifying and evaluating gingival inflammation.
|
Baseline and 1, 3 and 6 months after implant loading
|
|
Probing depth
Time Frame: Baseline and 1, 3 and 6 months after implant loading
|
The changes in probing pocket depth after implant loading.Probing pocket depth was measured for determining periimplant health.
|
Baseline and 1, 3 and 6 months after implant loading
|
|
Bleeding on probing
Time Frame: Baseline and 1, 3 and 6 months after implant loading
|
The changes in bleeding on probing after implant loading.
Bleeding on probing was recorded for evaluating gingival inflammation.
|
Baseline and 1, 3 and 6 months after implant loading
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
January 2, 2017
First Submitted That Met QC Criteria
January 2, 2017
First Posted (Estimate)
January 4, 2017
Study Record Updates
Last Update Posted (Estimate)
January 4, 2017
Last Update Submitted That Met QC Criteria
January 2, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 03/2008-19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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