Peridontal DiseaseLipoxin A4NCT06700161
Investigation of Lipoxin A4, Annexin A1 and Interleukin-1 Beta Levels in Individuals With Periodontitis.
An observational study of Peridontal Disease, run by Eda Cetin Ozdemir at 1 site in Turkey (Türkiye).
Trial summary
Since the researchers thought that Annexin A1, Lipoxin A4 and IL-1 Beta parameters, which have been found to be related to inflammatory conditions, may increase in periodontitis, a common inflammatory gum disease, we wanted to evaluate the changes in Annexin A1, Lipoxin A4 and IL-1 Beta levels in the Gingival… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peridontal Disease
- What is being tested?
- Obtaining CGF from patients
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2024to 1 Nov 2024
- How long will I take part?
- 60 Days
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients applying to Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Periodontics
Who may be able to join
- The patient must be a volunteer
- He/she must be over 18 years old
- He/she must not have any systemic disease
Who cannot join
- Smoking, drinking alcohol
- Being pregnant or breastfeeding
- Not volunteering
- Having had periodontal treatment in the last 6 months
- Having used antibiotics or anti-inflammatory drugs in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Periodontics
Kahramanmaraş, Onikişubat, 46000
About this study
Official title: Investigation of Lipoxin A4, Annexin A1 and Interleukin-1 Beta Levels in Gingival Crevicular Fluid in Individuals With Stage 3 Grade A Periodontitis
Since the researchers thought that Annexin A1, Lipoxin A4 and IL-1 Beta parameters, which have been found to be related to inflammatory conditions, may increase in periodontitis, a common inflammatory gum disease, we wanted to evaluate the changes in Annexin A1, Lipoxin A4 and IL-1 Beta levels in the Gingival Crevicular Fluid of participants with periodontitis.
Read the detailed description
Periodontitis is a chronic, multifactorial inflammatory disease characterized by microbial-mediated, host-mediated inflammation, resulting in periodontal attachment loss and eventual tooth loss. Given the high prevalence and systemic effects of periodontitis, research into the pathogenesis and treatment of periodontal disease is crucial to improving oral health and overall health outcomes.
In recent years, there has been great interest in determining the role of lipid mediators in pro- and anti-inflammatory events, which are of great importance in the pathogenesis of periodontitis. LIPOXIN A4 (LXA4), which serves as an inflammatory shutdown signal, is produced from arachidonic acid via interactions between individual lipoxygenases. Preclinical models have demonstrated the potential and efficacy of LXA4 in preventing the onset of periodontitis and treating periodontal disease by regenerating lost periodontium. LXA4 is produced by the dual oxygenation of arachidonic acid by 5-lipoxygenase and 12-lipoxygenase and mediates inflammatory suppression signals in vivo. LXA4 is biosynthesized by leukocytes, endothelial cells, and platelets via transcellular pathways and has potent inhibitory effects on various inflammatory mechanisms.
Annexins (ANXA) belong to the calcium (Ca+2) binding protein family that plays a role in inflammatory host defense. ANXA1, also known as lipocortin 1, is an anti-phospholipase protein that binds to cell membranes via a calcium-dependent pathway. ANXA1 inhibits the production of proinflammatory lipid mediators by inhibiting the activity of phospholipase A2. In addition, ANXA1 can modify many different steps and various cells involved in the inflammatory process. ANXA1 has long been classified as an anti-inflammatory protein due to its control over leukocyte-mediated immune responses. An ex vivo study has shown that the induction and translocation of ANXA1 protein to the cell membrane is stimulated by IL-6 . It has also been reported to be a critical negative regulator of proinflammatory mediators including IL-1, IL-6 and cyclooxygenase-2, while it has also been reported to stimulate the release of the anti-inflammatory cytokine IL-10 .
Since the researchers thought that Annexin A1, Lipoxin A4 and IL-1 Beta parameters, which have been found to be related to inflammatory conditions, may increase in periodontitis, a common inflammatory gum disease, we wanted to evaluate the changes in Annexin A1, Lipoxin A4 and IL-1 Beta levels in the Gingival Crevicular Fluid of participants with periodontitis.
- Conditions
- Peridontal Disease
- Being tested
- Obtaining CGF from patients
- Keywords
- periodontal disease, Anneksin, lipoksin
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obtaining CGF from patientsOther
Periodontal clinical parameters and Annexin and Lipoxin parameters in CGF will be compared between the test and control groups
| Study group | Role | What they receive |
|---|---|---|
| Control group | Healthy group Receives: Other: Obtaining CGF from patients | |
| Test group | Stage III Grade C Periodontitis Receives: Other: Obtaining CGF from patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Annexin and Lipoxin parameters in CGF in periodontal disease
We expect Annexin and Lipoxin parameters to decrease and IL-1b levels to increase in periodontal disease.
Measured: 6 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start16 Mar 2024
- Primary completion31 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peridontal DiseaseStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Eda Cetin Ozdemir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eda Cetin Ozdemir, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700161
- Sponsor's protocol ID
- 09.05.2024-117
- Other IDs
- 2024/4-13 M
- Acronym
- Lipoxin A4
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ı don't want to share
Publications
Tobon-Arroyave SI, Isaza-Guzman DM, Gomez-Ortega J, Florez-Alzate AA. Salivary levels of specialized pro-resolving lipid mediators as indicators of periodontal health/disease status. J Clin Periodontol. 2019 Oct;46(10):978-990. doi: 10.1111/jcpe.13173. Epub 2019 Aug 20.
PubMed 31339183Casarin RCV, Salmon CR, Stolf CS, Paz HES, Rangel TP, Domingues RR, Pauletti BA, Paes-Leme AF, Araujo C, Santamaria MP, Ruiz KS, Monteiro MF. Salivary annexin A1: A candidate biomarker for periodontitis. J Clin Periodontol. 2023 Jul;50(7):942-951. doi: 10.1111/jcpe.13803. Epub 2023 Mar 19.
PubMed 36935103Ma R, Liu Y, Xu Y, Duan D. Lipoxin A4 levels predict site-specific clinical improvements post scaling and root planing and correlate negatively with periodontal pathogens in severe periodontitis. BMC Oral Health. 2024 Feb 8;24(1):204. doi: 10.1186/s12903-024-03948-w.
PubMed 38331747Schenkein HA, Papapanou PN, Genco R, Sanz M. Mechanisms underlying the association between periodontitis and atherosclerotic disease. Periodontol 2000. 2020 Jun;83(1):90-106. doi: 10.1111/prd.12304.
PubMed 32385879
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Lipoxin A4, Annexin A1 and Interleukin-1 Beta Levels in Gingival Crevicular Fluid in Individuals With Stage 3 Grade A Periodontitis
- ClinicalTrials.gov ID
- NCT06700161
- Acronym / sponsor ID
- Lipoxin A4 / 09.05.2024-117
- Conditions
- Peridontal Disease
- Keywords
- periodontal disease, Anneksin, lipoksin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eda Cetin OzdemirUniversity, hospital or other
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 21 Nov 2024 (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.
Since the researchers thought that Annexin A1, Lipoxin A4 and IL-1 Beta parameters, which have been found to be related to inflammatory conditions, may increase in periodontitis, a common inflammatory gum disease, we wanted to evaluate the changes in Annexin A1, Lipoxin A4 and IL-1 Beta levels in the Gingival Crevicular Fluid of participants with periodontitis.
Detailed description
Periodontitis is a chronic, multifactorial inflammatory disease characterized by microbial-mediated, host-mediated inflammation, resulting in periodontal attachment loss and eventual tooth loss. Given the high prevalence and systemic effects of periodontitis, research into the pathogenesis and treatment of periodontal disease is crucial to improving oral health and overall health outcomes.
In recent years, there has been great interest in determining the role of lipid mediators in pro- and anti-inflammatory events, which are of great importance in the pathogenesis of periodontitis. LIPOXIN A4 (LXA4), which serves as an inflammatory shutdown signal, is produced from arachidonic acid via interactions between individual lipoxygenases. Preclinical models have demonstrated the potential and efficacy of LXA4 in preventing the onset of periodontitis and treating periodontal disease by regenerating lost periodontium. LXA4 is produced by the dual oxygenation of arachidonic acid by 5-lipoxygenase and 12-lipoxygenase and mediates inflammatory suppression signals in vivo. LXA4 is biosynthesized by leukocytes, endothelial cells, and platelets via transcellular pathways and has potent inhibitory effects on various inflammatory mechanisms.
Annexins (ANXA) belong to the calcium (Ca+2) binding protein family that plays a role in inflammatory host defense. ANXA1, also known as lipocortin 1, is an anti-phospholipase protein that binds to cell membranes via a calcium-dependent pathway. ANXA1 inhibits the production of proinflammatory lipid mediators by inhibiting the activity of phospholipase A2. In addition, ANXA1 can modify many different steps and various cells involved in the inflammatory process. ANXA1 has long been classified as an anti-inflammatory protein due to its control over leukocyte-mediated immune responses. An ex vivo study has shown that the induction and translocation of ANXA1 protein to the cell membrane is stimulated by IL-6 . It has also been reported to be a critical negative regulator of proinflammatory mediators including IL-1, IL-6 and cyclooxygenase-2, while it has also been reported to stimulate the release of the anti-inflammatory cytokine IL-10 .
Since the researchers thought that Annexin A1, Lipoxin A4 and IL-1 Beta parameters, which have been found to be related to inflammatory conditions, may increase in periodontitis, a common inflammatory gum disease, we wanted to evaluate the changes in Annexin A1, Lipoxin A4 and IL-1 Beta levels in the Gingival Crevicular Fluid of participants with periodontitis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 60 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Obtaining CGF from patientsHealthy group |
| Test group | – | Other: Obtaining CGF from patientsStage III Grade C Periodontitis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients applying to Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Periodontics
Key inclusion criteria (3 listed)
- The patient must be a volunteer
- He/she must be over 18 years old
- He/she must not have any systemic disease
Key exclusion criteria (5 listed)
- Smoking, drinking alcohol
- Being pregnant or breastfeeding
- Not volunteering
- Having had periodontal treatment in the last 6 months
- Having used antibiotics or anti-inflammatory drugs in the last 6 months.
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 |
|---|---|---|
| Obtaining CGF from patientsPeriodontal clinical parameters and Annexin and Lipoxin parameters in CGF will be compared between the test and control groups | Other | Control group, Test group |
Primary outcome
Changes in Annexin and Lipoxin parameters in CGF in periodontal disease
Time frame: 6 mounth
We expect Annexin and Lipoxin parameters to decrease and IL-1b levels to increase in periodontal disease.
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 21 Nov 2024.
- Background: PubMed 31339183Tobon-Arroyave SI, Isaza-Guzman DM, Gomez-Ortega J, Florez-Alzate AA. Salivary levels of specialized pro-resolving lipid mediators as indicators of periodontal health/disease status. J Clin Periodontol. 2019 Oct;46(10):978-990. doi: 10.1111/jcpe.13173. Epub 2019 Aug 20.
- Background: PubMed 36935103Casarin RCV, Salmon CR, Stolf CS, Paz HES, Rangel TP, Domingues RR, Pauletti BA, Paes-Leme AF, Araujo C, Santamaria MP, Ruiz KS, Monteiro MF. Salivary annexin A1: A candidate biomarker for periodontitis. J Clin Periodontol. 2023 Jul;50(7):942-951. doi: 10.1111/jcpe.13803. Epub 2023 Mar 19.
- Background: PubMed 38331747Ma R, Liu Y, Xu Y, Duan D. Lipoxin A4 levels predict site-specific clinical improvements post scaling and root planing and correlate negatively with periodontal pathogens in severe periodontitis. BMC Oral Health. 2024 Feb 8;24(1):204. doi: 10.1186/s12903-024-03948-w.
- Background: PubMed 32385879Schenkein HA, Papapanou PN, Genco R, Sanz M. Mechanisms underlying the association between periodontitis and atherosclerotic disease. Periodontol 2000. 2020 Jun;83(1):90-106. doi: 10.1111/prd.12304.
- Reference link to study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No. ı don't want to share
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peridontal Disease, run by Eda Cetin Ozdemir at 1 site in Turkey (Türkiye).
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 3 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Changes in Annexin and Lipoxin parameters in CGF in periodontal disease (time frame: 6 mounth). 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 NCT06700161, which also lists 4 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 21 Nov 2024.