Implant LoadingNCT03009942
Biochemical Mediators After Implant Loading
An observational study of Implant Loading, run by Gazi University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Loading
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2012
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Twenty patients with one or more implants restored with fixed crown prostheses
Who may be able to join
- Patients with ≥ 20 teeth, no systemic diseases that could affect bone metabolism, no smoking habits, and had one or more implants
Who cannot join
None listed.
About this study
Official title: 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
Read the 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.
- Conditions
- Implant Loading
- Keywords
- nitric oxide, arginase, loading
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical parameters (nitric oxide and arginase) in periimplant sulcular fluid and saliva
The changes in nitric oxide and arginase levels after implant loading were determined.
Measured: Baseline and 1, 3 and 6 months after implant loading
Secondary outcomes (4)
Plaque index
The changes in plaque index after implant loading. Plaque index was recorded for determining and classifying oral hygiene status.
Measured: Baseline and 1, 3 and 6 months after implant loading
Gingival index
The changes in gingival index after implant loading. Gingival index was recorded for classifying and evaluating gingival inflammation.
Measured: Baseline and 1, 3 and 6 months after implant loading
Probing depth
The changes in probing pocket depth after implant loading.Probing pocket depth was measured for determining periimplant health.
Measured: Baseline and 1, 3 and 6 months after implant loading
Bleeding on probing
The changes in bleeding on probing after implant loading. Bleeding on probing was recorded for evaluating gingival inflammation.
Measured: Baseline and 1, 3 and 6 months after implant loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant LoadingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurdan Ozmeric, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009942
- Sponsor's protocol ID
- 03/2008-19
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2017
- Last updated
- 4 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitric Oxide and Arginase Levels in Peri-Implant Tissues After Delayed Loading
- ClinicalTrials.gov ID
- NCT03009942
- Acronym / sponsor ID
- 03/2008-19
- Conditions
- Implant Loading
- Keywords
- nitric oxide, arginase, loading
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jan 2017 (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.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Twenty patients with one or more implants restored with fixed crown prostheses
Key inclusion criteria (1 listed)
- Patients with ≥ 20 teeth, no systemic diseases that could affect bone metabolism, no smoking habits, and had one or more implants
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Plaque index
Time frame: Baseline and 1, 3 and 6 months after implant loading
Gingival index
Time frame: Baseline and 1, 3 and 6 months after implant loading
Probing depth
Time frame: 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
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 4 Jan 2017.
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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?
An observational study of Implant Loading, run by Gazi 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 1 inclusion and 0 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 4 Jan 2017. 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?
Biochemical parameters (nitric oxide and arginase) in periimplant sulcular fluid and saliva (time frame: Baseline and 1, 3 and 6 months after implant loading). 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 4 Jan 2017.