InflammationNCT02848378
Advanced Oxidation Protein Product and Monocyte Chemoattractant Protein-1 in Periodontal Disease
An observational study of Inflammation and Periodontal Disease, run by Kırıkkale University.
Trial summary
This study investigates the levels of advanced oxidation protein product and monocyte chemoattractant protein-1 in gingival crevicular fluid in periodontal disease and health. 25 participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally healthy subjects are included into this study. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Periodontal Disease
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Apr 2015
- 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 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally healthy subjects are included.
Who may be able to join
- Clinical diagnosis of chronic periodontitis and gingivitis
Who cannot join
- Systemic illnesses
- Any medications known to affect the periodontium
- Pregnancy and lactation
About this study
Official title: The Levels of Advanced Oxidation Protein Product and Monocyte Chemoattractant Protein-1 in Gingival Crevicular Fluid in Periodontal Disease and Health
This study investigates the levels of advanced oxidation protein product and monocyte chemoattractant protein-1 in gingival crevicular fluid in periodontal disease and health. 25 participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally healthy subjects are included into this study. In each participant, four sites are identified for gingival crevicular fluid samples.
Read the detailed description
Oxidative stress is the disequilibrium between the formation of free radicals and antioxidant defense mechanisms via damaging cellular macromolecules (DNA, protein, lipid, etc..) which are susceptible to oxidative damage.
Advanced oxidation protein product is identified as a new marker of protein oxidation.
Monocyte chemoattractant protein-1 is a major chemoattractant for lymphocytes, monocytes and macrophages.
- Conditions
- Inflammation, Periodontal Disease
- Keywords
- Advanced Oxidation Protein Products, Gingival crevicular fluid, Monocyte chemoattractant protein-1, Periodontal Disease
- Medical subject headings
- Inflammation, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic periodontitis group | Subjects who have moderate to severe alveolar bone loss and clinical attachment level (CAL) ≥5 mm and probing depth (PD) ≥6mm in multiple sites of all four quadrants of the mouth but with no evidence of rapid progression | |
| Gingivitis group | Subjects who show gingival inflammation that is based on the presence of bleeding on probing (BOP) at >50% of sites in the whole mouth, no clinical and radiographic signs of periodontitis | |
| Periodontally healthy group | Subjects who have no sites with PD >3mm and CAL >0 mm, a BOP score of <15% at the examination and no alveolar bone loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced oxidation protein product (nmol)
Measured: Before periodontal treatment
Secondary outcomes (2)
Monocyte chemoattractant protein-1(pg)
Measured: Before periodontal treatment
The probing depth (mm), clinical attachment level (mm), plaque index scores (0-3) and gingival index scores (0-3)
Measured: Before periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Karsiyaka Hendek, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848378
- Sponsor's protocol ID
- 2014/17
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Levels of Advanced Oxidation Protein Product and Monocyte Chemoattractant Protein-1 in Gingival Crevicular Fluid in Periodontal Disease and Health
- ClinicalTrials.gov ID
- NCT02848378
- Acronym / sponsor ID
- 2014/17
- Conditions
- Inflammation, Periodontal Disease
- Keywords
- Advanced Oxidation Protein Products, Gingival crevicular fluid, Monocyte chemoattractant protein-1, Periodontal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Jul 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.
This study investigates the levels of advanced oxidation protein product and monocyte chemoattractant protein-1 in gingival crevicular fluid in periodontal disease and health. 25 participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally healthy subjects are included into this study. In each participant, four sites are identified for gingival crevicular fluid samples.
Detailed description
Oxidative stress is the disequilibrium between the formation of free radicals and antioxidant defense mechanisms via damaging cellular macromolecules (DNA, protein, lipid, etc..) which are susceptible to oxidative damage.
Advanced oxidation protein product is identified as a new marker of protein oxidation.
Monocyte chemoattractant protein-1 is a major chemoattractant for lymphocytes, monocytes and macrophages.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic periodontitis group | – | –Subjects who have moderate to severe alveolar bone loss and clinical attachment level (CAL) ≥5 mm and probing depth (PD) ≥6mm in multiple sites of all four quadrants of the mouth but with no evidence of rapid progression |
| Gingivitis group | – | –Subjects who show gingival inflammation that is based on the presence of bleeding on probing (BOP) at >50% of sites in the whole mouth, no clinical and radiographic signs of periodontitis |
| Periodontally healthy group | – | –Subjects who have no sites with PD >3mm and CAL >0 mm, a BOP score of <15% at the examination and no alveolar bone loss. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally healthy subjects are included.
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic periodontitis and gingivitis
Key exclusion criteria (3 listed)
- Systemic illnesses
- Any medications known to affect the periodontium
- Pregnancy and lactation
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
Advanced oxidation protein product (nmol)
Time frame: Before periodontal treatment
2 secondary outcomes
Monocyte chemoattractant protein-1(pg)
Time frame: Before periodontal treatment
The probing depth (mm), clinical attachment level (mm), plaque index scores (0-3) and gingival index scores (0-3)
Time frame: Before periodontal treatment
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 28 Jul 2016.
- Individual participant dataSharing planned: No
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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 Inflammation and Periodontal Disease, run by Kırıkkale 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 3 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 28 Jul 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?
Advanced oxidation protein product (nmol) (time frame: Before periodontal treatment). 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 28 Jul 2016.