PeriodontitisNCT06135116
Regulatory T Cell With Related Interleukins in Periodontal Disease Progression
An observational study of Periodontitis and Gingivitis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
T Regulatory cells which suppressor subset of T cells and related cytokines remain in blood and infiltrates into the tissue under need. The role of Treg and related cytokines in succession of periodontal inflammation is recently a subject of research interest. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis
- What is being tested?
- Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Jan 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sixty persons will be selected from the attendance of the out-patient clinic, Oral Medicine and Periodontology Department, Faculty of Dentistry, Al-Azhar University, Assiut. They divided according to the periodontal health status into three groups.
Who may be able to join
- periodontally healthy persons without any signs of periodontal disease. This was determined by the absence of attachment loss and bleeding upon probing either ˂ 10% or probing depth ˂3 mm.
- persons exhibiting generalized chronic gingivitis exhibiting signs of erythema, bleeding on probing up to 20%, edema, probing pocket depth less than 3 mm and no periodontal attachment loss.
- persons having severe generalized form of chronic periodontitis exhibiting PPD ≥ 6 mm, CAL ≥ 5mm and bone loss affecting at least six teeth as observed in dental periapical radiograph.
Who cannot join
- Patients with systemic diseases according to Modified Cornell Medical Index criteria
- Patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection.
- Patients subjected to previous periodontal therapy 6 months before sampling.
- Patients with systemic or local inflammatory conditions other than periodontal disease.
- The smokers.
- Neither lactating nor pregnant.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of oral medicine, Periodontology, Oral diagnosis and dental radiology Faculty of dental medicine
Asyut, Asyut Governorate, 71111
About this study
Official title: CD4+CD25+High FOXp3+ Regulatory T Cell With Related Interleukins and Vitamin D-binding Protein in Periodontal Disease Progression : Synergy or Cocaphony
T Regulatory cells which suppressor subset of T cells and related cytokines remain in blood and infiltrates into the tissue under need. The role of Treg and related cytokines in succession of periodontal inflammation is recently a subject of research interest. Chronic gingivitis and periodontitis being chronic inflammatory diseases can upregulate various cytokines in the systemic circulation and gingival crevicular fluid. This study aimed to compare levels of Tregs with Interleukin-21, 22, 33, 35 and vitamin D-binding protein in blood and GCF of periodontally healthy persons, chronic gingivitis patients, and severe chronic periodontitis patients.
Read the detailed description
T regs infiltration might reveal a trial to control tissue damage, however it also might be suggestive of a destructive effect of Tregs in periodontitis . Tregs can actually play a damaging role as this cells can annoyingly weaken the immune reaction towards infectious agents that could be possibly harmful in a periodontal environment . Immunopathology of Treg cell mediated via its pro-inflammatory cytokines during inflammatory conditions. IL-33 "recent member of pro-inflammatory IL-1 category" was recognized as placard in the stability of Foxp3+ Treg cell at mucosal sites. IL-33 has either pro- or anti-inflammatory property according to the disease and the model. It was speculated that IL-33 could improve the propagation from suppressive to dysregulated Treg cells in a dose-dependent manner . Interleukin (IL)-21 which member of the type I (ℽ chain) cytokine family has the ability to minimize FoxP3 expression and restraining Treg suppressor function and homeostasis . The purpose from this study was to assess the role of circulating and localized Treg with their related cytokines in patients with inflammation of periodontal tissues and to correlate their levels with disease progression.
- Conditions
- Periodontitis, Gingivitis
- Being tested
- Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA
- Keywords
- inflammation, Periodontitis, Cytokines, Vitamin D-Binding Protein, Interleukin-33, nterleukin-21
- Medical subject headings
- Periodontitis, Gingivitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISADiagnostic test
Gingival crevicular fluid samples collection After removing supragingival plaque, sampling sites were isolated by cotton rolls and dried using air syringe, GCF samples were collected by inserting standardized paper point in the sulcus/ pocket at the proximal-facial line angle of six preselected sites in each patient teeth . Fluid was sucked by paper points for 30 seconds. The samples were immediately placed inside graduated eppendorf vials containing 250µl phosphate-buffered saline (PBS), and transported to the laboratory for subsequent assays .
Blood Samples Collection From control and patient groups and under standard aseptic conditions, the peripheral blood was collected in Ethelene Diamine Tetra Acetic Acid (EDTA) coated vacutainer tubes (K2 EDTA) 5.4mg (BD vacutainer) and transferred immediately to flow cytometric analysis lab.
| Study group | Role | What they receive |
|---|---|---|
| periodontally healthy | twenty persons without any signs of periodontal disease. This was determined by the absence of attachment loss and bleeding upon probing either ˂ 10% or probing depth ˂3 mm. Receives: Diagnostic Test: Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA | |
| chronic gingivitis | twenty persons exhibiting generalized chronic gingivitis exhibiting signs of erythema, bleeding on probing up to 20%, edema, probing pocket depth less than 3 mm and no periodontal attachment loss. Receives: Diagnostic Test: Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA | |
| chronic periodontitis | twenty patients having severe generalized form of chronic periodontitis exhibiting PPD ≥ 6 mm, CAL ≥ 5mm and bone loss affecting at least six teeth as observed in dental periapical radiograph Receives: Diagnostic Test: Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treg cells frequency
evaluation of frequency of systemic and GCF levels of T regs in patients (periodontitis and gingivitis) and healthy group.Regulatory T cells were quantitively estimated using fluoroisothiocyanate (FITC)-conjugated Foxp3 (e Bioscience, USA), phycoerythrin (PE) conjugated CD25 (IQ Product, The Netherland) and peridinium-chlorophyll-protein (Per-CP)-conjugated CD4 (Becton Dickinson, Bioscience, USA).
Measured: baseline(through clinical diagnosis completion)
Cytokines levels (IL-22, IL-21, IL-35, IL-33) and vitamin D binding protien
comparative evaluation of systemic and GCF levels of cytokines in different periodontal conditions; healthy, gingivitis and periodontitis.they were measured by a commercially available enzyme-linked immunosorbent assay kits as following; ELISA kit (Legend Max, BioLegend, San Diego, CA, USA) with undetectable level below 20 pg/ml for IL-21, ELISA kit (RayBiotech. Norcross, Georgia, USA) with undetectable level below 8 pg/ml for IL-22, ELISA kit (GenWay Biotech Inc. San Diego, CA, USA) with undetectable level below 0.7ng/ml for IL-33, ELISA kit (Glory Science CO., Ltd, Del Rio, TX, USA) for IL-35 and finally ELISA kit (BioSource Systems, Invitrogen, Grand Island, NY, USA) for DBP.
Measured: baseline(through clinical diagnosis completion)
Secondary outcomes (4)
dental Plaque score
measured by O'Leary Plaque score as following; bacterial deposits where be stained with a disclosing solution to facilitate their detection. Calculation = the number of plaque containing surfaces / the total number of available surfaces. In the rating system, 0% indicates absence of plaque, with 15 %, 20 %, and > 40% indicating an increased percentage of plaque accumulation.
Measured: baseline(through clinical diagnosis completion)
Bleeding on probing (BoP)
By a force of 0.25 N. by a manual pressure of sensitive probe, recorded on distal, facial, mesial, gingival surfaces. Bleeding on probing (BoP) Calculated as following; Number of bleeding surfaces / total number of tooth surface) multiplying in one hundred and expressed in percentage (%). In the rating system, 0 indicates absence of bleeding on probing (healthy), with 15%, 20% (gingivitis) and >20% indicating an increased percentage of inflammation/infection (periodontitis).
Measured: Baseline(through clinical diagnosis completion)
Probing pocket depth
it was measured from the gingival margin to the base of the pocket by William's graduated periodontal probe
Measured: Baseline(through clinical diagnosis completion)
Attachment level
it was measured by subtracting the distance from the cemento-enamel junction to the free gingival margin from the distance from the free gingival margin to the base of the pocket both were properly measured using William's graduated probe and the difference between the two measurements yields the attachment level
Measured: Baseline(through clinical diagnosis completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion23 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asem Mohammed Kamel Ali, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135116
- Sponsor's protocol ID
- Treg in periodontitis
- Status last verified
- Jan 2024
- First submitted
- 12 Nov 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang X, Meng H, Sun X, Xu L, Zhang L, Shi D, Feng X, Lu R, Chen Z. Elevation of vitamin D-binding protein levels in the plasma of patients with generalized aggressive periodontitis. J Periodontal Res. 2013 Feb;48(1):74-9. doi: 10.1111/j.1600-0765.2012.01505.x. Epub 2012 Jul 18.
PubMed 22803589Nakajima T, Ueki-Maruyama K, Oda T, Ohsawa Y, Ito H, Seymour GJ, Yamazaki K. Regulatory T-cells infiltrate periodontal disease tissues. J Dent Res. 2005 Jul;84(7):639-43. doi: 10.1177/154405910508400711.
PubMed 15972593Hasan A, Palmer RM. A clinical guide to periodontology: pathology of periodontal disease. Br Dent J. 2014 Apr;216(8):457-61. doi: 10.1038/sj.bdj.2014.299.
PubMed 24762896
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD4+CD25+High FOXp3+ Regulatory T Cell With Related Interleukins and Vitamin D-binding Protein in Periodontal Disease Progression : Synergy or Cocaphony
- ClinicalTrials.gov ID
- NCT06135116
- Acronym / sponsor ID
- Treg in periodontitis
- Conditions
- Periodontitis, Gingivitis
- Keywords
- inflammation, Periodontitis, Cytokines, Vitamin D-Binding Protein, Interleukin-33, nterleukin-21
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 18 Nov 2023 (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.
T Regulatory cells which suppressor subset of T cells and related cytokines remain in blood and infiltrates into the tissue under need. The role of Treg and related cytokines in succession of periodontal inflammation is recently a subject of research interest. Chronic gingivitis and periodontitis being chronic inflammatory diseases can upregulate various cytokines in the systemic circulation and gingival crevicular fluid. This study aimed to compare levels of Tregs with Interleukin-21, 22, 33, 35 and vitamin D-binding protein in blood and GCF of periodontally healthy persons, chronic gingivitis patients, and severe chronic periodontitis patients.
Detailed description
T regs infiltration might reveal a trial to control tissue damage, however it also might be suggestive of a destructive effect of Tregs in periodontitis . Tregs can actually play a damaging role as this cells can annoyingly weaken the immune reaction towards infectious agents that could be possibly harmful in a periodontal environment . Immunopathology of Treg cell mediated via its pro-inflammatory cytokines during inflammatory conditions. IL-33 "recent member of pro-inflammatory IL-1 category" was recognized as placard in the stability of Foxp3+ Treg cell at mucosal sites. IL-33 has either pro- or anti-inflammatory property according to the disease and the model. It was speculated that IL-33 could improve the propagation from suppressive to dysregulated Treg cells in a dose-dependent manner . Interleukin (IL)-21 which member of the type I (ℽ chain) cytokine family has the ability to minimize FoxP3 expression and restraining Treg suppressor function and homeostasis . The purpose from this study was to assess the role of circulating and localized Treg with their related cytokines in patients with inflammation of periodontal tissues and to correlate their levels with disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periodontally healthy | – | Diagnostic Test: Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISAtwenty persons without any signs of periodontal disease. This was determined by the absence of attachment loss and bleeding upon probing either ˂ 10% or probing depth ˂3 mm. |
| chronic gingivitis | – | Diagnostic Test: Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISAtwenty persons exhibiting generalized chronic gingivitis exhibiting signs of erythema, bleeding on probing up to 20%, edema, probing pocket depth less than 3 mm and no periodontal attachment loss. |
| chronic periodontitis | – | Diagnostic Test: Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISAtwenty patients having severe generalized form of chronic periodontitis exhibiting PPD ≥ 6 mm, CAL ≥ 5mm and bone loss affecting at least six teeth as observed in dental periapical radiograph |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty persons will be selected from the attendance of the out-patient clinic, Oral Medicine and Periodontology Department, Faculty of Dentistry, Al-Azhar University, Assiut. They divided according to the periodontal health status into three groups.
Key inclusion criteria (3 listed)
- periodontally healthy persons without any signs of periodontal disease. This was determined by the absence of attachment loss and bleeding upon probing either ˂ 10% or probing depth ˂3 mm.
- persons exhibiting generalized chronic gingivitis exhibiting signs of erythema, bleeding on probing up to 20%, edema, probing pocket depth less than 3 mm and no periodontal attachment loss.
- persons having severe generalized form of chronic periodontitis exhibiting PPD ≥ 6 mm, CAL ≥ 5mm and bone loss affecting at least six teeth as observed in dental periapical radiograph.
Key exclusion criteria (6 listed)
- Patients with systemic diseases according to Modified Cornell Medical Index criteria
- Patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection.
- Patients subjected to previous periodontal therapy 6 months before sampling.
- Patients with systemic or local inflammatory conditions other than periodontal disease.
- The smokers.
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 |
|---|---|---|
| Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISAGingival crevicular fluid samples collection After removing supragingival plaque, sampling sites were isolated by cotton rolls and dried using air syringe, GCF samples were collected by inserting standardized paper point in the sulcus/ pocket at the proximal-facial line angle of six preselected sites in each patient teeth . Fluid was sucked by paper points for 30 seconds. The samples were immediately placed inside graduated eppendorf vials containing 250µl phosphate-buffered saline (PBS), and transported to the laboratory for subsequent assays . Blood Samples Collection From control and patient groups and under standard aseptic conditions, the peripheral blood was collected in Ethelene Diamine Tetra Acetic Acid (EDTA) coated vacutainer tubes (K2 EDTA) 5.4mg (BD vacutainer) and transferred immediately to flow cytometric analysis lab. | Diagnostic test | chronic gingivitis, chronic periodontitis, periodontally healthy |
Primary outcome
Treg cells frequency
Time frame: baseline(through clinical diagnosis completion)
evaluation of frequency of systemic and GCF levels of T regs in patients (periodontitis and gingivitis) and healthy group.Regulatory T cells were quantitively estimated using fluoroisothiocyanate (FITC)-conjugated Foxp3 (e Bioscience, USA), phycoerythrin (PE) conjugated CD25 (IQ Product, The Netherland) and peridinium-chlorophyll-protein (Per-CP)-conjugated CD4 (Becton Dickinson, Bioscience, USA).
Cytokines levels (IL-22, IL-21, IL-35, IL-33) and vitamin D binding protien
Time frame: baseline(through clinical diagnosis completion)
comparative evaluation of systemic and GCF levels of cytokines in different periodontal conditions; healthy, gingivitis and periodontitis.they were measured by a commercially available enzyme-linked immunosorbent assay kits as following; ELISA kit (Legend Max, BioLegend, San Diego, CA, USA) with undetectable level below 20 pg/ml for IL-21, ELISA kit (RayBiotech. Norcross, Georgia, USA) with undetectable level below 8 pg/ml for IL-22, ELISA kit (GenWay Biotech Inc. San Diego, CA, USA) with undetectable level below 0.7ng/ml for IL-33, ELISA kit (Glory Science CO., Ltd, Del Rio, TX, USA) for IL-35 and finally ELISA kit (BioSource Systems, Invitrogen, Grand Island, NY, USA) for DBP.
4 secondary outcomes
dental Plaque score
Time frame: baseline(through clinical diagnosis completion)
Bleeding on probing (BoP)
Time frame: Baseline(through clinical diagnosis completion)
Probing pocket depth
Time frame: Baseline(through clinical diagnosis completion)
Attachment level
Time frame: Baseline(through clinical diagnosis completion)
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 30 Jan 2024.
- Background: PubMed 22803589Zhang X, Meng H, Sun X, Xu L, Zhang L, Shi D, Feng X, Lu R, Chen Z. Elevation of vitamin D-binding protein levels in the plasma of patients with generalized aggressive periodontitis. J Periodontal Res. 2013 Feb;48(1):74-9. doi: 10.1111/j.1600-0765.2012.01505.x. Epub 2012 Jul 18.
- Background: PubMed 15972593Nakajima T, Ueki-Maruyama K, Oda T, Ohsawa Y, Ito H, Seymour GJ, Yamazaki K. Regulatory T-cells infiltrate periodontal disease tissues. J Dent Res. 2005 Jul;84(7):639-43. doi: 10.1177/154405910508400711.
- Background: PubMed 24762896Hasan A, Palmer RM. A clinical guide to periodontology: pathology of periodontal disease. Br Dent J. 2014 Apr;216(8):457-61. doi: 10.1038/sj.bdj.2014.299.
- 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.
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 Periodontitis and Gingivitis, run by Al-Azhar University at 1 site in Egypt.
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 6 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 30 Jan 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 Egypt. 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?
Treg cells frequency (time frame: baseline(through clinical diagnosis completion)). The study lists 2 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 NCT06135116, which also lists 3 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 30 Jan 2024.