Periodontal DiseasesNCT03225950
Interaction Between Immune Cells and Bacteria Associated With Periodontitis
An observational study of Periodontal Diseases and Periodontitis, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
This study evaluates the interaction between host immune cells and bacteria associated with periodontitis. It comprises biological material from donors with and without periodontal disease. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Aggressive Periodontitis
- What is being tested?
- Anti-CCP- and anti-P.g.-antibodies titers, Analysis of selected single nucleotide polymorphisms (SNPs) and periodontitis-associated bacteria presence
- How many people
- 90 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Feb 2017to 23 Mar 2020
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study includes 170 participants, which are legally competent e.i. above 18 years of age and general decision competent. The participants are divided into three groups: 1) Participants with chronic periodontitis (n=35), 2) participants with aggressive periodontitis (n=35) and 3) healthy participants without periodontal disease (n=100). The participants are recruited from the Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark and assigned to a group in accordance with the periodontal disease classification system in 1999 American Academy of Periodontology.
Who may be able to join
- 50-60 years of age.
- Interproximal attachment loss at minimum 3 teeth besides molars and incisors.
- Clinical attachment loss at minimum 10 sites identified by bleeding and pus upon probing.
- Visible radiographic bone loss.
- Medically healthy donors.
- 19-40 years of age.
Show all 13Show fewer
- Interproximal attachment loss at minimum 3 teeth besides molars and incisors.
- Clinical attachment loss at minimum 10 sites identified by bleeding and pus upon probing.
- Visible radiographic bone loss.
- Medically healthy donors.
- Inclusion criteria for healthy donors: (age: 19-40 years; 50-60 years)
- No sign of inflammatory conditions or other general systemic diseases.
- Medically healthy donors.
Who cannot join
- Pregnant and breastfeeding.
- Antibiotic treatment within 6 months.
- Suffer from periodontal manifestations caused by systemic diseases e.i. genetic diseases, haematologic anomalies or syndromes.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Institute for Inflammation Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen University Hospital.
Copenhagen, 2200
Section for Periodontology, Microbiology and Community Dentistry, Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen
Copenhagen, 2200
About this study
This study evaluates the interaction between host immune cells and bacteria associated with periodontitis. It comprises biological material from donors with and without periodontal disease. Specifically, we collect a spit and blood sample to conduct in vitro stimulations and measurements of selected parameters related to periodontitis to clarify obscure areas in the immunologic pathogenesis of this disease.
Read the detailed description
Periodontitis is a prevalent, multifactorial inflammatory disease characterized by the interaction between microorganisms organized in biofilms on tooth surfaces and host immune cells, leading to an inflammatory destruction of the tooth-supporting tissues and - if left untreated - eventually tooth loss. Periodontitis affects up to 50% of the population in the United States of America, and is classified in an aggressive and a chronic form depending on genetic factors, age of onset, speed and severity of attachment loss.
The onset of periodontitis is caused by an immunologic imbalance between host immune cells and residing microorganisms in subgingival pockets. The host immune cells are capable of enhancing both a protective and a destructive inflammatory response towards the microorganisms through the release of inflammatory mediators e.i. proinflammatory and antiinflammatory cytokines.
The role of antibodies in periodontitis is also unclear. Some studies show an excessive antibody level against bacteria associated with periodontitis e.g. Porphyromonas gingivalis (P.g.).
In general, this study contributes to a profound understanding of the host immune cells role in the onset and pathogenesis of periodontitis by comparing healthy versus diseased donors immunologic responses toward pathogene and apathogene microorganisms and their genetic background.
- Conditions
- Periodontal Diseases, Periodontitis, Aggressive Periodontitis, Immunologic Disease, Microbial Disease, Periodontal Pocket
- Being tested
- In vitro stimulation of blood with periodontitis-associated- and control bacteria, Anti-CCP- and anti-P.g.-antibodies titers, Analysis of selected single nucleotide polymorphisms (SNPs), periodontitis-associated bacteria presence
- Keywords
- Periodontal disease, Periodontitis, Aggressive periodontitis, Dysbiosis, Inflammation, Regulation, Cytokines, Bacteria, Porphyromonas gingivalis, Saliva, Anti-CCP, Peptidyl arginine deiminases, Single nucleotide polymorphisms
- Medical subject headings
- Periodontal Diseases, Periodontitis, Aggressive Periodontitis, Immune System Diseases, Periodontal Pocket, Inflammation, Gingivitis, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro stimulation of blood with periodontitis-associated- and control bacteriaOther
Peripheral mononuclear blood cells are stimulated with periodontitis-associated- and control bacteria to measure the amount of positive cytokine-producing cells.
Anti-CCP- and anti-P.g.-antibodies titersDiagnostic test
Anitbody titers will be measured in saliva and serum samples.
Analysis of selected single nucleotide polymorphisms (SNPs)Genetic
DNA obtained from saliva samples will be used to determine the genotype of the participants for selected SNPs.
periodontitis-associated bacteria presenceDiagnostic test
Determination of the presence of periodontitis-associated bacteria e.i. Porphyromonas gingivalis in saliva and blood samples.
| Study group | Role | What they receive |
|---|---|---|
| Chronic periodontitis donors | * Donors are medically healthy.
* Slow to moderate attachment loss and bone destruction.
* Good correlation between etiological factors and serverity of attachment loss. Receives: Other: In vitro stimulation of blood with periodontitis-associated- and control bacteria; Diagnostic Test: Anti-CCP- and anti-P.g.-antibodies titers; Genetic: Analysis of selected single nucleotide polymorphisms (SNPs); Diagnostic Test: periodontitis-associated bacteria presence | |
| Aggressive periodontitis donors | * Donors are medically healthy.
* Rapid attachment loss and bone destruction.
* Familial aggregation.
* No correlation between etiological factors and serverity of attachment loss. Receives: Other: In vitro stimulation of blood with periodontitis-associated- and control bacteria; Diagnostic Test: Anti-CCP- and anti-P.g.-antibodies titers; Genetic: Analysis of selected single nucleotide polymorphisms (SNPs); Diagnostic Test: periodontitis-associated bacteria presence | |
| Control donors | * Donors are medically healthy.
* No sign of inflammatory conditions. Receives: Other: In vitro stimulation of blood with periodontitis-associated- and control bacteria; Diagnostic Test: Anti-CCP- and anti-P.g.-antibodies titers; Genetic: Analysis of selected single nucleotide polymorphisms (SNPs); Diagnostic Test: periodontitis-associated bacteria presence |
What is being measured
The primary outcome is the main question the study is designed to answer.
periodontitis-associated- and control bacterial stimulation of host immune cells.
Identification and determination of the amount of cytokine-producing immune cells when stimulated with bacteria associated with periodontitis including pro- and antiinflammatory cytokines.
Genuses: Porphyromonas, Prevotella, Eikenella, Aggregatibacter, Actinomyces, Lactobacillus, Bifidobacterium, Rothia.
Measured: Aug. 2020
Anti-cyclic citrullinated peptides (anti-CCP) antibodies titers.
Determination of the prevalence of anti-CCP-positive periodontitis patients through measure of anti-CCP antibody titers in serum samples and correlation with the level of antibodies to P. gingivalis, and to the abundancy of the bacterium in saliva.
Measured: Aug. 2020
P. gingivalis presence and related antibodies.
Determination of P. gingivalis presence in saliva and serum samples through RT-qPCR and determination of the level of antibodies towards the bacterium using in-house Luminex-based technology.
Measured: Aug. 2020
Single nucleotide polymorphism (SNP) analysis.
Investigation of the potential association between periodontitis and selected polymorphisms in the PADI genes using multiplex bead-based SNP assays with the Luminex technology.
Measured: Aug. 2020
Secondary outcomes (2)
Cytokine profile in saliva.
Determination of the cytokine profile in saliva samples from subject with periodontitis and healthy controls with Luminex based technology.
Measured: Aug. 2020
Presence of other periodontal bacteria.
Determination of the presence of other periodontal bacteria through RT-qPCR assays.
Measured: Aug. 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Feb 2017
- Primary completion12 Oct 2018
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Responsible party
- Principal investigator, Anne Katrine Danielsen, University of Copenhagen
- Investigators
- Palle Holmstrup, DDS, PhD, Dr Odont, Study director, University of CopenhagenClaus Henrik Nielsen, PhD, MSc, MD, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225950
- Sponsor's protocol ID
- H-16024734
- Status last verified
- Oct 2018
- First submitted
- 19 Jul 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to other researchers in accordance with our approved Human Subjects Protection application in Denmark.
Publications
Bartold PM, Van Dyke TE. Periodontitis: a host-mediated disruption of microbial homeostasis. Unlearning learned concepts. Periodontol 2000. 2013 Jun;62(1):203-17. doi: 10.1111/j.1600-0757.2012.00450.x.
PubMed 23574467Neely AL, Holford TR, Loe H, Anerud A, Boysen H. The natural history of periodontal disease in man. Risk factors for progression of attachment loss in individuals receiving no oral health care. J Periodontol. 2001 Aug;72(8):1006-15. doi: 10.1902/jop.2001.72.8.1006.
PubMed 11525431Eke PI, Dye BA, Wei L, Slade GD, Thornton-Evans GO, Borgnakke WS, Taylor GW, Page RC, Beck JD, Genco RJ. Update on Prevalence of Periodontitis in Adults in the United States: NHANES 2009 to 2012. J Periodontol. 2015 May;86(5):611-22. doi: 10.1902/jop.2015.140520. Epub 2015 Feb 17.
PubMed 25688694Armitage GC. Development of a classification system for periodontal diseases and conditions. Northwest Dent. 2000 Nov-Dec;79(6):31-5.
PubMed 11413609Haffajee AD, Socransky SS, Patel MR, Song X. Microbial complexes in supragingival plaque. Oral Microbiol Immunol. 2008 Jun;23(3):196-205. doi: 10.1111/j.1399-302X.2007.00411.x.
PubMed 18402605Damgaard C, Holmstrup P, Van Dyke TE, Nielsen CH. The complement system and its role in the pathogenesis of periodontitis: current concepts. J Periodontal Res. 2015 Jun;50(3):283-93. doi: 10.1111/jre.12209. Epub 2014 Jul 5.
PubMed 25040158Liu YC, Lerner UH, Teng YT. Cytokine responses against periodontal infection: protective and destructive roles. Periodontol 2000. 2010 Feb;52(1):163-206. doi: 10.1111/j.1600-0757.2009.00321.x. No abstract available.
PubMed 20017801Kinane DF, Preshaw PM, Loos BG; Working Group 2 of Seventh European Workshop on Periodontology. Host-response: understanding the cellular and molecular mechanisms of host-microbial interactions--consensus of the Seventh European Workshop on Periodontology. J Clin Periodontol. 2011 Mar;38 Suppl 11:44-8. doi: 10.1111/j.1600-051X.2010.01682.x.
PubMed 21323703Pussinen PJ, Jousilahti P, Alfthan G, Palosuo T, Asikainen S, Salomaa V. Antibodies to periodontal pathogens are associated with coronary heart disease. Arterioscler Thromb Vasc Biol. 2003 Jul 1;23(7):1250-4. doi: 10.1161/01.ATV.0000072969.71452.87. Epub 2003 Apr 24.
PubMed 12714435Pussinen PJ, Nyyssonen K, Alfthan G, Salonen R, Laukkanen JA, Salonen JT. Serum antibody levels to Actinobacillus actinomycetemcomitans predict the risk for coronary heart disease. Arterioscler Thromb Vasc Biol. 2005 Apr;25(4):833-8. doi: 10.1161/01.ATV.0000157982.69663.59. Epub 2005 Feb 3.
PubMed 15692101Berglundh T, Donati M. Aspects of adaptive host response in periodontitis. J Clin Periodontol. 2005;32 Suppl 6:87-107. doi: 10.1111/j.1600-051X.2005.00820.x.
PubMed 16128832Fillatreau S. Cytokine-producing B cells as regulators of pathogenic and protective immune responses. Ann Rheum Dis. 2013 Apr;72 Suppl 2:ii80-4. doi: 10.1136/annrheumdis-2012-202253. Epub 2012 Dec 19.
PubMed 23253921Belstrom D, Paster BJ, Fiehn NE, Bardow A, Holmstrup P. Salivary bacterial fingerprints of established oral disease revealed by the Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) technique. J Oral Microbiol. 2016 Jan 14;8:30170. doi: 10.3402/jom.v8.30170. eCollection 2016.
PubMed 26782357Belstrom D, Holmstrup P, Bardow A, Kokaras A, Fiehn NE, Paster BJ. Comparative analysis of bacterial profiles in unstimulated and stimulated saliva samples. J Oral Microbiol. 2016 Mar 16;8:30112. doi: 10.3402/jom.v8.30112. eCollection 2016.
PubMed 26987356Massarenti L, Nielsen CH, Danielsen AK, Jensen PO, Enevold C, Damgaard C. Evaluation of circulating IgG antibodies against Porphyromonas gingivalis or its gingipains as serological markers of periodontitis and carriage of the bacterium. J Periodontol. 2025 Feb;96(2):119-128. doi: 10.1002/JPER.23-0766. Epub 2024 Jun 17.
PubMed 38884611
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Immune Cells and Bacteria Associated With Periodontitis
- ClinicalTrials.gov ID
- NCT03225950
- Acronym / sponsor ID
- H-16024734
- Conditions
- Periodontal Diseases, Periodontitis, Aggressive Periodontitis, Immunologic Disease, Microbial Disease, Periodontal Pocket
- Keywords
- Periodontal disease, Periodontitis, Aggressive periodontitis, Dysbiosis, Inflammation, Regulation, Cytokines, Bacteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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 interaction between host immune cells and bacteria associated with periodontitis. It comprises biological material from donors with and without periodontal disease. Specifically, we collect a spit and blood sample to conduct in vitro stimulations and measurements of selected parameters related to periodontitis to clarify obscure areas in the immunologic pathogenesis of this disease.
Detailed description
Periodontitis is a prevalent, multifactorial inflammatory disease characterized by the interaction between microorganisms organized in biofilms on tooth surfaces and host immune cells, leading to an inflammatory destruction of the tooth-supporting tissues and - if left untreated - eventually tooth loss. Periodontitis affects up to 50% of the population in the United States of America, and is classified in an aggressive and a chronic form depending on genetic factors, age of onset, speed and severity of attachment loss.
The onset of periodontitis is caused by an immunologic imbalance between host immune cells and residing microorganisms in subgingival pockets. The host immune cells are capable of enhancing both a protective and a destructive inflammatory response towards the microorganisms through the release of inflammatory mediators e.i. proinflammatory and antiinflammatory cytokines.
The role of antibodies in periodontitis is also unclear. Some studies show an excessive antibody level against bacteria associated with periodontitis e.g. Porphyromonas gingivalis (P.g.).
In general, this study contributes to a profound understanding of the host immune cells role in the onset and pathogenesis of periodontitis by comparing healthy versus diseased donors immunologic responses toward pathogene and apathogene microorganisms and their genetic background.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic periodontitis donors | – | Other: In vitro stimulation of blood with periodontitis-associated- and control bacteria, Diagnostic Test: Anti-CCP- and anti-P.g.-antibodies titers, Genetic: Analysis of selected single nucleotide polymorphisms (SNPs), Diagnostic Test: periodontitis-associated bacteria presence* Donors are medically healthy. * Slow to moderate attachment loss and bone destruction. * Good correlation between etiological factors and serverity of attachment loss. |
| Aggressive periodontitis donors | – | Other: In vitro stimulation of blood with periodontitis-associated- and control bacteria, Diagnostic Test: Anti-CCP- and anti-P.g.-antibodies titers, Genetic: Analysis of selected single nucleotide polymorphisms (SNPs), Diagnostic Test: periodontitis-associated bacteria presence* Donors are medically healthy. * Rapid attachment loss and bone destruction. * Familial aggregation. * No correlation between etiological factors and serverity of attachment loss. |
| Control donors | – | Other: In vitro stimulation of blood with periodontitis-associated- and control bacteria, Diagnostic Test: Anti-CCP- and anti-P.g.-antibodies titers, Genetic: Analysis of selected single nucleotide polymorphisms (SNPs), Diagnostic Test: periodontitis-associated bacteria presence* Donors are medically healthy. * No sign of inflammatory conditions. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study includes 170 participants, which are legally competent e.i. above 18 years of age and general decision competent. The participants are divided into three groups: 1) Participants with chronic periodontitis (n=35), 2) participants with aggressive periodontitis (n=35) and 3) healthy participants without periodontal disease (n=100). The participants are recruited from the Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark and assigned to a group in accordance with the periodontal disease classification system in 1999 American Academy of Periodontology.
Key inclusion criteria (13 listed)
- 50-60 years of age.
- Interproximal attachment loss at minimum 3 teeth besides molars and incisors.
- Clinical attachment loss at minimum 10 sites identified by bleeding and pus upon probing.
- Visible radiographic bone loss.
- Medically healthy donors.
Key exclusion criteria (3 listed)
- Pregnant and breastfeeding.
- Antibiotic treatment within 6 months.
- Suffer from periodontal manifestations caused by systemic diseases e.i. genetic diseases, haematologic anomalies or syndromes.
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 |
|---|---|---|
| In vitro stimulation of blood with periodontitis-associated- and control bacteriaPeripheral mononuclear blood cells are stimulated with periodontitis-associated- and control bacteria to measure the amount of positive cytokine-producing cells. | Other | Aggressive periodontitis donors, Chronic periodontitis donors, Control donors |
| Anti-CCP- and anti-P.g.-antibodies titersAnitbody titers will be measured in saliva and serum samples. | Diagnostic test | Aggressive periodontitis donors, Chronic periodontitis donors, Control donors |
| Analysis of selected single nucleotide polymorphisms (SNPs)DNA obtained from saliva samples will be used to determine the genotype of the participants for selected SNPs. | Genetic | Aggressive periodontitis donors, Chronic periodontitis donors, Control donors |
| periodontitis-associated bacteria presenceDetermination of the presence of periodontitis-associated bacteria e.i. Porphyromonas gingivalis in saliva and blood samples. | Diagnostic test | Aggressive periodontitis donors, Chronic periodontitis donors, Control donors |
Primary outcome
periodontitis-associated- and control bacterial stimulation of host immune cells.
Time frame: Aug. 2020
Identification and determination of the amount of cytokine-producing immune cells when stimulated with bacteria associated with periodontitis including pro- and antiinflammatory cytokines. Genuses: Porphyromonas, Prevotella, Eikenella, Aggregatibacter, Actinomyces, Lactobacillus, Bifidobacterium, Rothia.
Anti-cyclic citrullinated peptides (anti-CCP) antibodies titers.
Time frame: Aug. 2020
Determination of the prevalence of anti-CCP-positive periodontitis patients through measure of anti-CCP antibody titers in serum samples and correlation with the level of antibodies to P. gingivalis, and to the abundancy of the bacterium in saliva.
P. gingivalis presence and related antibodies.
Time frame: Aug. 2020
Determination of P. gingivalis presence in saliva and serum samples through RT-qPCR and determination of the level of antibodies towards the bacterium using in-house Luminex-based technology.
Single nucleotide polymorphism (SNP) analysis.
Time frame: Aug. 2020
Investigation of the potential association between periodontitis and selected polymorphisms in the PADI genes using multiplex bead-based SNP assays with the Luminex technology.
2 secondary outcomes
Cytokine profile in saliva.
Time frame: Aug. 2020
Presence of other periodontal bacteria.
Time frame: Aug. 2020
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 24 Mar 2020.
- Background: PubMed 23574467Bartold PM, Van Dyke TE. Periodontitis: a host-mediated disruption of microbial homeostasis. Unlearning learned concepts. Periodontol 2000. 2013 Jun;62(1):203-17. doi: 10.1111/j.1600-0757.2012.00450.x.
- Background: PubMed 11525431Neely AL, Holford TR, Loe H, Anerud A, Boysen H. The natural history of periodontal disease in man. Risk factors for progression of attachment loss in individuals receiving no oral health care. J Periodontol. 2001 Aug;72(8):1006-15. doi: 10.1902/jop.2001.72.8.1006.
- Background: PubMed 25688694Eke PI, Dye BA, Wei L, Slade GD, Thornton-Evans GO, Borgnakke WS, Taylor GW, Page RC, Beck JD, Genco RJ. Update on Prevalence of Periodontitis in Adults in the United States: NHANES 2009 to 2012. J Periodontol. 2015 May;86(5):611-22. doi: 10.1902/jop.2015.140520. Epub 2015 Feb 17.
- Background: PubMed 11413609Armitage GC. Development of a classification system for periodontal diseases and conditions. Northwest Dent. 2000 Nov-Dec;79(6):31-5.
- Background: PubMed 18402605Haffajee AD, Socransky SS, Patel MR, Song X. Microbial complexes in supragingival plaque. Oral Microbiol Immunol. 2008 Jun;23(3):196-205. doi: 10.1111/j.1399-302X.2007.00411.x.
- Background: PubMed 25040158Damgaard C, Holmstrup P, Van Dyke TE, Nielsen CH. The complement system and its role in the pathogenesis of periodontitis: current concepts. J Periodontal Res. 2015 Jun;50(3):283-93. doi: 10.1111/jre.12209. Epub 2014 Jul 5.
- Background: PubMed 20017801Liu YC, Lerner UH, Teng YT. Cytokine responses against periodontal infection: protective and destructive roles. Periodontol 2000. 2010 Feb;52(1):163-206. doi: 10.1111/j.1600-0757.2009.00321.x. No abstract available.
- Background: PubMed 21323703Kinane DF, Preshaw PM, Loos BG; Working Group 2 of Seventh European Workshop on Periodontology. Host-response: understanding the cellular and molecular mechanisms of host-microbial interactions--consensus of the Seventh European Workshop on Periodontology. J Clin Periodontol. 2011 Mar;38 Suppl 11:44-8. doi: 10.1111/j.1600-051X.2010.01682.x.
- Background: PubMed 12714435Pussinen PJ, Jousilahti P, Alfthan G, Palosuo T, Asikainen S, Salomaa V. Antibodies to periodontal pathogens are associated with coronary heart disease. Arterioscler Thromb Vasc Biol. 2003 Jul 1;23(7):1250-4. doi: 10.1161/01.ATV.0000072969.71452.87. Epub 2003 Apr 24.
- Background: PubMed 15692101Pussinen PJ, Nyyssonen K, Alfthan G, Salonen R, Laukkanen JA, Salonen JT. Serum antibody levels to Actinobacillus actinomycetemcomitans predict the risk for coronary heart disease. Arterioscler Thromb Vasc Biol. 2005 Apr;25(4):833-8. doi: 10.1161/01.ATV.0000157982.69663.59. Epub 2005 Feb 3.
- Background: PubMed 16128832Berglundh T, Donati M. Aspects of adaptive host response in periodontitis. J Clin Periodontol. 2005;32 Suppl 6:87-107. doi: 10.1111/j.1600-051X.2005.00820.x.
- Background: PubMed 23253921Fillatreau S. Cytokine-producing B cells as regulators of pathogenic and protective immune responses. Ann Rheum Dis. 2013 Apr;72 Suppl 2:ii80-4. doi: 10.1136/annrheumdis-2012-202253. Epub 2012 Dec 19.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers in accordance with our approved Human Subjects Protection application in Denmark.
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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.
Palle Holmstrup, DDS, PhD, Dr Odont study director
University of Copenhagen
Claus Henrik Nielsen, PhD, MSc, MD study director
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Periodontitis, run by University of Copenhagen at 2 sites in Denmark.
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 13 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 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
periodontitis-associated- and control bacterial stimulation of host immune cells. (time frame: Aug. 2020). The study lists 4 primary outcomes in all. 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 NCT03225950, which also lists 16 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 24 Mar 2020.