Aggressive PeriodontitisMCP-1NCT02927704
Gingival Crevicular Fluid Levels Of Monocyte Chemoattractant Protein-1
An observational study of Aggressive Periodontitis, run by Abant Izzet Baysal University.
Trial summary
The aim of this study is to estimate GCF MCP-1 levels of healthy and Aggressive periodontitis (AgP) subjects and to compare MCP-1 levels between Localized AgP (LAgP) and Generalized AgP (GAgP) to establish its predictive value/role for distinguishing LAgP and GAgP development. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aggressive Periodontitis
- What is being tested?
- Gingival crevicular fluid (GCF) sample
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Aug 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This cross-sectional case control study was carried out at Selcuk University, Faculty of Dentistry, Department of Periodontology. Aggressive periodontitis patients referred as case were diagnosed by single examiner.The control group included periodontally healthy volunteers from staff and other subjects referring to the School of Dentistry.
Who may be able to join
- Periodontally Healthy control group (n: 80) had < 3mm PD, < 2 GI and no signs of interproximal attachment loss and a history of periodontal disease.
- The AgP group included individuals diagnosed with localized AgP (LAgP) or generalized AgP (GAgP) who were otherwise healthy. Periodontal attachment loss ≥4 mm accompanied by interproximal bone loss without gingival recession not involving more than two permanent teeth, other than the first molars and incisors were diagnosed with LAgP (n: 50); patients with involvement of at least three teeth, other than the first molars and incisors with an attachment loss ≥4 mm accompanied by interproximal bone loss without gingival recession were diagnosed with GAgP (n: 30).
Who cannot join
- Patients who have any systemic diseases or conditions that could effect the periodontium
- hepatitis and/or immunodeficiency virus infection
- a history of periodontal treatment and antibiotic therapy within the 6 months
- < 16 teeth in their mouth
- Subjects who had smoked and were ongoing orthodontic treatment were excluded.
About this study
Official title: Gingival Crevicular Fluid Levels Of Monocyte Chemoattractant Protein-1 in Patients With Aggressive Periodontitis
The aim of this study is to estimate GCF MCP-1 levels of healthy and Aggressive periodontitis (AgP) subjects and to compare MCP-1 levels between Localized AgP (LAgP) and Generalized AgP (GAgP) to establish its predictive value/role for distinguishing LAgP and GAgP development.
Read the detailed description
Patients with aggressive periodontitis (AgP) are diagnosed as rapid and severe periodontal destruction commonly in younger systemically healthy individuals (Armitage, 1999). Although periopathogenic bacteria are essential for initiation, this alone does not be responsible for the manifestation and severity of the clinical status/phenotype (Offenbacher et al., 2008), suggesting an imbalance between host and bacterial load (Kinane et al., 2007). Response to bacterial biofilm is determined by the host immune system (Mahanonda and Pichyangkul, 2007, Amano, 2010) in which genetic and enviromental factors modify and may get individuals more susceptible or resistant to the periodontal diseases (Kulkarni and Kinane, 2014).
The role of whether an impaired or a hyperinflammatory host response is responsible for the progression of aggressive periodontitis has been a topic of discussion. Regarding to this topic Shaddox et al. (2016) studied the whole blood specimens collected from LAgP subjects and stimulated with plaque sample generated from healthy or diseased sites. And as a result, LAgP subjects displayed hyperinflammatory response regardless of contents of bacterial stimulus. In an another research hyperinflammatory responders LAgP subjects presented the lowest reductions in clinical parameters, on the contrary low responders showed the highest reductions after treatment (Allin et al., 2016). Similarly Garrison and Nichols (1989) reported that hyper-inflammatory monocyte phenotype can be deterministic in periodontal destruction. In the view of the aforementioned findings, the aim of this study is to estimate GCF MCP-1 levels of healthy and AgP subjects and to compare MCP-1 levels between LAgP and GAgP to establish its predictive value/role for distinguishing LAgP and GAgP development.
A total of 160 subjects including, 80 AgP and 80 age and gender matched periodontally healthy (H) controls were recruited in this cross-sectional study. Clinical periodontal measurements including plaque index (PI), gingival index (GI), proping depth (PD) and clinical attachment loss (CAL) were performed. GCF samples were collected from 160 patients including 50 LAgP, 30 GAgP and 80 H. Volume of GCF samples were measured by an electronic device (Periotron 8000, OroFlow Inc.) and GCF MCP-1 was measured by an enzyme-linked immunosorbent assay "ELISA".
- Conditions
- Aggressive Periodontitis
- Being tested
- Gingival crevicular fluid (GCF) sample
- Keywords
- Aggressive Periodontitis, monocyte chemoattractant protein-1, gingival crevicular fluid, enzyme-linked immunosorbent assay
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival crevicular fluid (GCF) sampleOther
Single intervention has been performed for each subject. GCF samples were collected from four multi rooted teeth (premolar/molar) one of in each quadrant including two maxilla and two mandibula by single examiner in conjunction with clinical measurements in this intervention.
| Study group | Role | What they receive |
|---|---|---|
| case (Aggressive periodontitis) | Single intervention has been performed for each subject. Gingival crevicular fluid sample was obtained in conjunction with clinical measurements in this intervention. Receives: Other: Gingival crevicular fluid (GCF) sample | |
| control (Periodontally healthy subjects) | Single intervention has been performed for each subject. Gingival crevicular fluid sample was obtained in conjunction with clinical measurements in this intervention. Receives: Other: Gingival crevicular fluid (GCF) sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of GCF MCP-1 levels in patients with AgP
Measured: 1 year
Secondary outcomes (1)
Measurement of clinical periodontal parameters in patients with AgP and compare between LAgP and GAgP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startMar 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aggressive PeriodontitisStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Collaborators
- Selcuk University
- Responsible party
- Principal investigator, Sadiye Gunpinar, Abant Izzet Baysal University
- Investigators
- Sadiye Gunpinar, Asst. Prof., Principal investigator, Abant Izzet Baysal University, Faculty of Dentistry, Periodontology DepartmentNilgun O Alptekin, Prof., Principal investigator, Baskent University, Faculty of Dentistry, Periodontology DepartmentNiyazi Dundar, Dr., Principal investigator, Selcuk University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927704
- Sponsor's protocol ID
- 2011/016
- Other IDs
- 11102024, konya2013
- Acronym
- MCP-1
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Armitage GC. Periodontal diagnoses and classification of periodontal diseases. Periodontol 2000. 2004;34:9-21. doi: 10.1046/j.0906-6713.2002.003421.x. No abstract available.
PubMed 14717852Lee E, Yang YH, Ho YP, Ho KY, Tsai CC. Potential role of vascular endothelial growth factor, interleukin-8 and monocyte chemoattractant protein-1 in periodontal diseases. Kaohsiung J Med Sci. 2003 Aug;19(8):406-15. doi: 10.1016/S1607-551X(09)70484-X.
PubMed 12962428Kurtis B, Tuter G, Serdar M, Akdemir P, Uygur C, Firatli E, Bal B. Gingival crevicular fluid levels of monocyte chemoattractant protein-1 and tumor necrosis factor-alpha in patients with chronic and aggressive periodontitis. J Periodontol. 2005 Nov;76(11):1849-55. doi: 10.1902/jop.2005.76.11.1849.
PubMed 16274303Gupta M, Chaturvedi R, Jain A. Role of monocyte chemoattractant protein-1 (MCP-1) as an immune-diagnostic biomarker in the pathogenesis of chronic periodontal disease. Cytokine. 2013 Mar;61(3):892-7. doi: 10.1016/j.cyto.2012.12.012. Epub 2013 Jan 30.
PubMed 23375122Emingil G, Atilla G, Huseyinov A. Gingival crevicular fluid monocyte chemoattractant protein-1 and RANTES levels in patients with generalized aggressive periodontitis. J Clin Periodontol. 2004 Oct;31(10):829-34. doi: 10.1111/j.1600-051X.2004.00584.x.
PubMed 15367184Thunell DH, Tymkiw KD, Johnson GK, Joly S, Burnell KK, Cavanaugh JE, Brogden KA, Guthmiller JM. A multiplex immunoassay demonstrates reductions in gingival crevicular fluid cytokines following initial periodontal therapy. J Periodontal Res. 2010 Feb;45(1):148-52. doi: 10.1111/j.1600-0765.2009.01204.x. Epub 2009 Jul 8.
PubMed 19602112Tymkiw KD, Thunell DH, Johnson GK, Joly S, Burnell KK, Cavanaugh JE, Brogden KA, Guthmiller JM. Influence of smoking on gingival crevicular fluid cytokines in severe chronic periodontitis. J Clin Periodontol. 2011 Mar;38(3):219-28. doi: 10.1111/j.1600-051X.2010.01684.x. Epub 2010 Dec 29.
PubMed 21198766
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid Levels Of Monocyte Chemoattractant Protein-1 in Patients With Aggressive Periodontitis
- ClinicalTrials.gov ID
- NCT02927704
- Acronym / sponsor ID
- MCP-1 / 2011/016
- Conditions
- Aggressive Periodontitis
- Keywords
- Aggressive Periodontitis, monocyte chemoattractant protein-1, gingival crevicular fluid, enzyme-linked immunosorbent assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Collaborators
- Selcuk University
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Oct 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 aim of this study is to estimate GCF MCP-1 levels of healthy and Aggressive periodontitis (AgP) subjects and to compare MCP-1 levels between Localized AgP (LAgP) and Generalized AgP (GAgP) to establish its predictive value/role for distinguishing LAgP and GAgP development.
Detailed description
Patients with aggressive periodontitis (AgP) are diagnosed as rapid and severe periodontal destruction commonly in younger systemically healthy individuals (Armitage, 1999). Although periopathogenic bacteria are essential for initiation, this alone does not be responsible for the manifestation and severity of the clinical status/phenotype (Offenbacher et al., 2008), suggesting an imbalance between host and bacterial load (Kinane et al., 2007). Response to bacterial biofilm is determined by the host immune system (Mahanonda and Pichyangkul, 2007, Amano, 2010) in which genetic and enviromental factors modify and may get individuals more susceptible or resistant to the periodontal diseases (Kulkarni and Kinane, 2014).
The role of whether an impaired or a hyperinflammatory host response is responsible for the progression of aggressive periodontitis has been a topic of discussion. Regarding to this topic Shaddox et al. (2016) studied the whole blood specimens collected from LAgP subjects and stimulated with plaque sample generated from healthy or diseased sites. And as a result, LAgP subjects displayed hyperinflammatory response regardless of contents of bacterial stimulus. In an another research hyperinflammatory responders LAgP subjects presented the lowest reductions in clinical parameters, on the contrary low responders showed the highest reductions after treatment (Allin et al., 2016). Similarly Garrison and Nichols (1989) reported that hyper-inflammatory monocyte phenotype can be deterministic in periodontal destruction. In the view of the aforementioned findings, the aim of this study is to estimate GCF MCP-1 levels of healthy and AgP subjects and to compare MCP-1 levels between LAgP and GAgP to establish its predictive value/role for distinguishing LAgP and GAgP development.
A total of 160 subjects including, 80 AgP and 80 age and gender matched periodontally healthy (H) controls were recruited in this cross-sectional study. Clinical periodontal measurements including plaque index (PI), gingival index (GI), proping depth (PD) and clinical attachment loss (CAL) were performed. GCF samples were collected from 160 patients including 50 LAgP, 30 GAgP and 80 H. Volume of GCF samples were measured by an electronic device (Periotron 8000, OroFlow Inc.) and GCF MCP-1 was measured by an enzyme-linked immunosorbent assay "ELISA".
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case (Aggressive periodontitis) | – | Other: Gingival crevicular fluid (GCF) sampleSingle intervention has been performed for each subject. Gingival crevicular fluid sample was obtained in conjunction with clinical measurements in this intervention. |
| control (Periodontally healthy subjects) | – | Other: Gingival crevicular fluid (GCF) sampleSingle intervention has been performed for each subject. Gingival crevicular fluid sample was obtained in conjunction with clinical measurements in this intervention. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This cross-sectional case control study was carried out at Selcuk University, Faculty of Dentistry, Department of Periodontology. Aggressive periodontitis patients referred as case were diagnosed by single examiner.The control group included periodontally healthy volunteers from staff and other subjects referring to the School of Dentistry.
Key inclusion criteria (2 listed)
- Periodontally Healthy control group (n: 80) had < 3mm PD, < 2 GI and no signs of interproximal attachment loss and a history of periodontal disease.
- The AgP group included individuals diagnosed with localized AgP (LAgP) or generalized AgP (GAgP) who were otherwise healthy. Periodontal attachment loss ≥4 mm accompanied by interproximal bone loss without gingival recession not involving more than two permanent teeth, other than the first molars and incisors were diagnosed with LAgP (n: 50); patients with involvement of at least three teeth, other than the first molars and incisors with an attachment loss ≥4 mm accompanied by interproximal bone loss without gingival recession were diagnosed with GAgP (n: 30).
Key exclusion criteria (5 listed)
- Patients who have any systemic diseases or conditions that could effect the periodontium
- hepatitis and/or immunodeficiency virus infection
- a history of periodontal treatment and antibiotic therapy within the 6 months
- < 16 teeth in their mouth
- Subjects who had smoked and were ongoing orthodontic treatment were excluded.
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 (GCF) sampleSingle intervention has been performed for each subject. GCF samples were collected from four multi rooted teeth (premolar/molar) one of in each quadrant including two maxilla and two mandibula by single examiner in conjunction with clinical measurements in this intervention. | Other | case (Aggressive periodontitis), control (Periodontally healthy subjects) |
Primary outcome
Determination of GCF MCP-1 levels in patients with AgP
Time frame: 1 year
1 secondary outcome
Measurement of clinical periodontal parameters in patients with AgP and compare between LAgP and GAgP
Time frame: 1 year
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 7 Oct 2016.
- Background: PubMed 14717852Armitage GC. Periodontal diagnoses and classification of periodontal diseases. Periodontol 2000. 2004;34:9-21. doi: 10.1046/j.0906-6713.2002.003421.x. No abstract available.
- Background: PubMed 12962428Lee E, Yang YH, Ho YP, Ho KY, Tsai CC. Potential role of vascular endothelial growth factor, interleukin-8 and monocyte chemoattractant protein-1 in periodontal diseases. Kaohsiung J Med Sci. 2003 Aug;19(8):406-15. doi: 10.1016/S1607-551X(09)70484-X.
- Background: PubMed 16274303Kurtis B, Tuter G, Serdar M, Akdemir P, Uygur C, Firatli E, Bal B. Gingival crevicular fluid levels of monocyte chemoattractant protein-1 and tumor necrosis factor-alpha in patients with chronic and aggressive periodontitis. J Periodontol. 2005 Nov;76(11):1849-55. doi: 10.1902/jop.2005.76.11.1849.
- Background: PubMed 23375122Gupta M, Chaturvedi R, Jain A. Role of monocyte chemoattractant protein-1 (MCP-1) as an immune-diagnostic biomarker in the pathogenesis of chronic periodontal disease. Cytokine. 2013 Mar;61(3):892-7. doi: 10.1016/j.cyto.2012.12.012. Epub 2013 Jan 30.
- Background: PubMed 15367184Emingil G, Atilla G, Huseyinov A. Gingival crevicular fluid monocyte chemoattractant protein-1 and RANTES levels in patients with generalized aggressive periodontitis. J Clin Periodontol. 2004 Oct;31(10):829-34. doi: 10.1111/j.1600-051X.2004.00584.x.
- Background: PubMed 19602112Thunell DH, Tymkiw KD, Johnson GK, Joly S, Burnell KK, Cavanaugh JE, Brogden KA, Guthmiller JM. A multiplex immunoassay demonstrates reductions in gingival crevicular fluid cytokines following initial periodontal therapy. J Periodontal Res. 2010 Feb;45(1):148-52. doi: 10.1111/j.1600-0765.2009.01204.x. Epub 2009 Jul 8.
- Background: PubMed 21198766Tymkiw KD, Thunell DH, Johnson GK, Joly S, Burnell KK, Cavanaugh JE, Brogden KA, Guthmiller JM. Influence of smoking on gingival crevicular fluid cytokines in severe chronic periodontitis. J Clin Periodontol. 2011 Mar;38(3):219-28. doi: 10.1111/j.1600-051X.2010.01684.x. Epub 2010 Dec 29.
- 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.
Sadiye Gunpinar, Asst. Prof. principal investigator
Abant Izzet Baysal University, Faculty of Dentistry, Periodontology Department
Nilgun O Alptekin, Prof. principal investigator
Baskent University, Faculty of Dentistry, Periodontology Department
Niyazi Dundar, Dr. principal investigator
Selcuk University, Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
An observational study of Aggressive Periodontitis, run by Abant Izzet Baysal 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 2 inclusion and 5 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 7 Oct 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?
Determination of GCF MCP-1 levels in patients with AgP (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02927704, which also lists 7 linked publications.
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 7 Oct 2016.