PeriodontitisNCT05307068
IL-10, IL-12 and IL-18 Levels in the Gingival Crevicular Fluid of Patients With Periodontitis and Healthy Controls
An observational study of Periodontitis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is a multifactorial chronic inflammatory disease characterized by the destruction of the tissues supporting the tooth. The incidence and rate of progression of periodontal destruction involves a complex interaction between periodontopathic bacteria and immune system cells. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 30 Jun 2023
- How long will I take part?
- 15 Months
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In our study individuals who have Grade B-C stage III-IV periodontal disease according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions and individuals who have healthy gingiva will be selected
Who may be able to join
- •In patients who applied to Istanbul University Faculty of Dentistry, Department of Periodontology, periodontally healthy individuals who do not meet the above disease criteria, who do not have a history of periodontitis in any way, will be included in the study. Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.
Who cannot join
- Those with systemic modifying disease affecting periodontal status
- Smoker
- Have received antibiotic therapy or immunosuppressive therapy in the last 6 months
- Previously received periodontal treatment in the last 6 months
- Pregnancy and breastfeeding status
- Regular use of drugs that will affect systemic health
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Dentistry
Istanbul
About this study
Official title: Investigation of the Relationships and Clinical Parameters Between IL-10, IL-12 and IL-18 Levels in the Gingival Crevicular Fluid of Individuals With Grade B-C Stage III-IV Periodontitis
Periodontitis is a multifactorial chronic inflammatory disease characterized by the destruction of the tissues supporting the tooth. The incidence and rate of progression of periodontal destruction involves a complex interaction between periodontopathic bacteria and immune system cells. The complex cytokine network that mediates the immune response includes pro-inflammatory cytokines, anti-inflammatory cytokines, and specific cytokine receptors. Cytokines act as messengers to initiate, mediate, and control immune and inflammatory responses. It is known that the interaction of pro- and anti-inflammatory cytokines plays a very important role in the progression of periodontitis .
The immune response to infection is regulated by the balance between T helper (Th)1 and Th2-type cytokines. Since Th1, Th2, and monocyte-derived cytokines in gingival tissues and gingival crevicular fluid (GCF) play a role in periodontal inflammation, even a minimal imbalance in cytokine production may affect the induction of bone and collagen resorption in periodontal disease. For this reason, cytokines in inflamed periodontal tissues, which are the focus of many studies, are of great importance in the progression of periodontal disease.
In this study, our aim is to evaluate the local cytokine response in relation to the clinical periodontal status by determining the IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid of individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. In this way, besides clinical and radiographic determinations in the diagnosis of periodontal disease, IL-10, IL-12 and IL-18 are measured to evaluate whether these markers have an effect on the diagnosis of the disease.
Read the detailed description
Interleukin-10 (IL-10) is one of the most potent anti-inflammatory cytokines, as it induces T cell anergy (non-responsiveness to an antigen) and reduces the production of some pro-inflammatory cytokines. Altered expression of IL-10, however, genetic predisposition and the presence of specific periodontal bacteria may contribute to the disruption of the Th1/Th2 balance and the development of aggressive periodontitis.
Interleukin-12 (IL-12) is a heterodimer comprised of p35 and p40 subunits, which form the bioactive IL-12 (p70). IL-12 is an essential mediator of the early innate immune response and a key inducer of cellular immunity. Its most important task is to stimulate T cells and interferon-γ (IFN-γ) production by natural killer cells, thereby promoting Th1 responses. The importance of IL-12 is not limited to initiating an immune response, it may contribute to the maintenance of immunity. Because in the absence of IL-12, Th1 responses are rapidly lost.
Interleukin-18 (IL-18) is a pro-inflammatory cytokine belonging to the IL-1 cytokine family. This cytokine was originally identified as a natural killer and a cytokine that induces IFN-γ produced by T cells. IL-18 acts synergistically with IL-12 to support IFN-γ production and Th1 cell growth, but does not depend on IL-12 for its activity.
When this information is brought together, the evaluation of the effects of IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid on periodontal disease together with clinical parameters has been the point of our study.
It is planned to include 30 periodontally healthy individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions, who applied to Istanbul University Faculty of Dentistry Periodontology Department, after clinical and radiographic evaluations. All individuals to be included will be informed about the purpose and method of the study and their consent will be obtained.
Before the study, it will be ensured that the oral condition of the individual is not caused by any other factor (unknown systemic disease, blood disease, etc.). The individuals included in the study; systemic and oral anamnesis, smoking status, systemic disease status will be recorded and the following clinical measurements will be made.
Gingival crevicular fluid (GCF) samples will be taken from individuals suitable for the study model, and periodontal indices will be recorded. The levels of IL-10, IL-12 and IL-18 will be determined in the GCF samples taken. The researcher will not include individuals who have been included in other studies that have passed or will be approved by the ethics committee, and will not include individuals who will be included in this study, undertakes not to include it in its work.
Clinical measurements include Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Depth (PD), Free Gingival Margin (FGM), Clinical Attachment Level Measurement (CAL), Mobility parameters. The measurements were made by the same researcher from six different points of all teeth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal. It will be measured and recorded by a single person with the Williams (Hu-Friedy, USA) type periodontal probe. These measurements are non-invasive and will enable us to determine the periodontal status. After the clinical examination and measurements of the patients who met the inclusion criteria and signed the voluntary consent form, the gingival crevicular fluid samples to be taken from the patients will be analyzed and the results will be evaluated. Samples will be isolated from the gingival groove with the aid of absorbent paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) and biochemical analyzes will be made in the samples obtained by ELISA method in accordance with the protocols included in the kit. Biochemical analyzes will be carried out at Istanbul University, Istanbul Faculty of Medicine, Department of Medical Biochemistry.
The clinical evaluation methods planned to be applied in the study are listed below:
- Plaque Index
- Probing Depth
- Bleeding on Probing
- Clinical Attachment Level Measurement
- Free Gingival Margin
- Gingival Index
- Mobility Samples of paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) placed in the gingival groove will be placed in eppendorf tubes for laboratory examination in the session 1 week after the exact periodontal status is determined by periodontal measurements. Samples will be taken from areas with the deepest probable pocket depth. While obtaining gingival crevicular fluid samples, the area will be isolated with cotton pads and the microbial dental plaque on the tooth will be removed with cotton pellets, and then a short-term drying process will be done with air freshener from a 20 cm distance at a right angle. Then, standard absorbent 2x8 mm paper strips will be placed from the approximal regions to the entrance of the groove with slight resistance and after waiting for 30 seconds, each paper strip will be placed in an eppendorf tube and stored at -80°C. (New Brunswick Scientific Ultra Low Temperature Freezer). Samples will be taken from 6 teeth in each patient.
In case of bleeding from the gingival groove during sample collection, the sample will not be taken from that area.
GCF samples taken and stored at -80°C will be analyzed at Istanbul University, Istanbul Medical Faculty, Department of Medical Biochemistry. IL-10, IL-12 and IL-18 levels of GCF samples will be determined by ELISA method.
In the light of the data, the clinical conditions and biochemical analyzes of the patients will be compared and the relationship between them will be examined.
According to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions, an average of 11 units difference between the results obtained from interleukin biomarkers in the group of individuals with grade B-C stage III-IV periodontitis and healthy individuals, and a minimal sample to find the estimated 15-unit standard deviation significant size (assuming Type I error 5%, Type II error 20% assuming Power 0.80): 30 people for each group. Considering the wrong samples, 30+30 people will be taken into each group (30 healthy controls, 30 Periodontitis cases) Our study will be carried out on systemically healthy patients aged 18-65 years who were diagnosed with Grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions in the Periodontology Clinic of Istanbul University Faculty of Dentistry.
After the clinical examination and measurements of the patients who met the inclusion criteria and signed the voluntary consent form, the gingival crevicular fluid samples taken from the patients will be analyzed and the results will be evaluated. The samples will be isolated from the gingival crevicular with the help of the absorbent periopaper and biochemically analyzed with ELISA kits.
Periodontitis group:
- 18-65 years old
- Not having any systemic disease (diseases that do not affect the periodontal status)
- Non-smoker
- Have not received antibiotic treatment and/or used immunosuppressant medication in the last 6 months
- Have not received any periodontal treatment in the last 6 months
- No pregnancy and lactation
- Not using any medication regularly
- Having at least 20 teeth
- Grade B-C stage III-IV periodontal disease according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions
Healthy Group:
In patients who applied to Istanbul University Faculty of Dentistry, Department of Periodontology, periodontally healthy individuals who do not meet the above disease criteria, who do not have a history of periodontitis in any way, will be included in the study. Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.
- Conditions
- Periodontitis
- Being tested
- No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)
- Keywords
- periodontitis, healthy gingiva, grade b, grade c, stage III, stage IV
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)Other
No intervention was applied to the groups the samples will be collected in terms of the diagnosis (periodontitis, healthy)
| Study group | Role | What they receive |
|---|---|---|
| Grade B-C stage III-IV periodontitis group | Grade B: Moderate Moderate bone loss is observed compared to biofilm and % Root Bone Loss/age 0.25 to 1.0 is determined as grade B.
Stage III: Severe Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≤4.
Grade C: Rapid Rapid bone loss is observed compared to biofilm and % Root Bone Loss/age >1.0 is determined as grade C.
Stage IV:Advanced Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≥5. Need for complex rehabilition due to: Masticatory dysfunction, Secondary occlusal trauma(tooth mobility degree ≥2) Severe ridge defect,Bite collapse, drifting, flaring. Less than 20 remaining teeth (10 opposing pairs) Receives: Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy) | |
| Healthy control group | Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss. Receives: Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of GCF samples
Measurement of IL-10, IL-12, IL-18 levels in GCF with grade B-C stage III-IV periodontitis individuals
Measured: GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove
Secondary outcomes (1)
Measurement of GCF samples
Measurement of IL-10, IL-12, IL-18 levels in GCF with periodontal healthy individuals
Measured: GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start15 Apr 2022
- Primary completion30 Nov 2022
- Study completion30 Jun 2023
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 PeriodontitisStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif ilke Cebesoy, Istanbul University
- Investigators
- Emine Çifcibaşı, Assoc. Prof., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307068
- Sponsor's protocol ID
- 679625
- Status last verified
- Sep 2023
- First submitted
- 24 Jan 2022
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only clinical istatical analyses and GCF samples analyses will be shared
Publications
Geng Y, Li L, Wang X, He F, Zhou Y, Yang M, Xu Y. Interleukin-10 polymorphisms affect the key periodontal pathogens in Chinese periodontitis patients. Sci Rep. 2018 Jun 13;8(1):9068. doi: 10.1038/s41598-018-26236-4.
PubMed 29899423Borilova Linhartova P, Danek Z, Deissova T, Hromcik F, Lipovy B, Szaraz D, Janos J, Fassmann A, Bartova J, Drizhal I, Izakovicova Holla L. Interleukin Gene Variability and Periodontal Bacteria in Patients with Generalized Aggressive Form of Periodontitis. Int J Mol Sci. 2020 Jul 2;21(13):4728. doi: 10.3390/ijms21134728.
PubMed 32630798Orozco A, Gemmell E, Bickel M, Seymour GJ. Interleukin-1beta, interleukin-12 and interleukin-18 levels in gingival fluid and serum of patients with gingivitis and periodontitis. Oral Microbiol Immunol. 2006 Aug;21(4):256-60. doi: 10.1111/j.1399-302X.2006.00292.x.
PubMed 16842511Pai B S, Pradeep AR. Correlations between Interleukin-33 and -1alpha Levels in Gingival Crevicular Fluid and Plasma in Patients with Chronic or Aggressive Periodontitis and Disease-free Subjects. Bull Tokyo Dent Coll. 2019 Dec 10;60(4):279-289. doi: 10.2209/tdcpublication.2019-0002. Epub 2019 Nov 22.
PubMed 31761881Park AY, Scott P. Il-12: keeping cell-mediated immunity alive. Scand J Immunol. 2001 Jun;53(6):529-32. doi: 10.1046/j.1365-3083.2001.00917.x.
PubMed 11422900Clarke IJ, Tilbrook AJ, Galloway DB, Earl CR, Findlay JK, de Kretser DM. Inhibin in rams. J Reprod Fertil Suppl. 1991;43:163-70. No abstract available.
PubMed 1843338Cebesoy EI, Altaca M, Kocak-Oztug NA, Bingul I, Cifcibasi E. Associations between interleukin-10, -12, and - 18 and periodontal health and disease: a cross-sectional study. Clin Oral Investig. 2024 Jul 31;28(8):458. doi: 10.1007/s00784-024-05843-8.
PubMed 39080003
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationships and Clinical Parameters Between IL-10, IL-12 and IL-18 Levels in the Gingival Crevicular Fluid of Individuals With Grade B-C Stage III-IV Periodontitis
- ClinicalTrials.gov ID
- NCT05307068
- Acronym / sponsor ID
- 679625
- Conditions
- Periodontitis
- Keywords
- periodontitis, healthy gingiva, grade b, grade c, stage III, stage IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Apr 2022 (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.
Periodontitis is a multifactorial chronic inflammatory disease characterized by the destruction of the tissues supporting the tooth. The incidence and rate of progression of periodontal destruction involves a complex interaction between periodontopathic bacteria and immune system cells. The complex cytokine network that mediates the immune response includes pro-inflammatory cytokines, anti-inflammatory cytokines, and specific cytokine receptors. Cytokines act as messengers to initiate, mediate, and control immune and inflammatory responses. It is known that the interaction of pro- and anti-inflammatory cytokines plays a very important role in the progression of periodontitis .
The immune response to infection is regulated by the balance between T helper (Th)1 and Th2-type cytokines. Since Th1, Th2, and monocyte-derived cytokines in gingival tissues and gingival crevicular fluid (GCF) play a role in periodontal inflammation, even a minimal imbalance in cytokine production may affect the induction of bone and collagen resorption in periodontal disease. For this reason, cytokines in inflamed periodontal tissues, which are the focus of many studies, are of great importance in the progression of periodontal disease.
In this study, our aim is to evaluate the local cytokine response in relation to the clinical periodontal status by determining the IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid of individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. In this way, besides clinical and radiographic determinations in the diagnosis of periodontal disease, IL-10, IL-12 and IL-18 are measured to evaluate whether these markers have an effect on the diagnosis of the disease.
Detailed description
Interleukin-10 (IL-10) is one of the most potent anti-inflammatory cytokines, as it induces T cell anergy (non-responsiveness to an antigen) and reduces the production of some pro-inflammatory cytokines. Altered expression of IL-10, however, genetic predisposition and the presence of specific periodontal bacteria may contribute to the disruption of the Th1/Th2 balance and the development of aggressive periodontitis.
Interleukin-12 (IL-12) is a heterodimer comprised of p35 and p40 subunits, which form the bioactive IL-12 (p70). IL-12 is an essential mediator of the early innate immune response and a key inducer of cellular immunity. Its most important task is to stimulate T cells and interferon-γ (IFN-γ) production by natural killer cells, thereby promoting Th1 responses. The importance of IL-12 is not limited to initiating an immune response, it may contribute to the maintenance of immunity. Because in the absence of IL-12, Th1 responses are rapidly lost.
Interleukin-18 (IL-18) is a pro-inflammatory cytokine belonging to the IL-1 cytokine family. This cytokine was originally identified as a natural killer and a cytokine that induces IFN-γ produced by T cells. IL-18 acts synergistically with IL-12 to support IFN-γ production and Th1 cell growth, but does not depend on IL-12 for its activity.
When this information is brought together, the evaluation of the effects of IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid on periodontal disease together with clinical parameters has been the point of our study.
It is planned to include 30 periodontally healthy individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions, who applied to Istanbul University Faculty of Dentistry Periodontology Department, after clinical and radiographic evaluations. All individuals to be included will be informed about the purpose and method of the study and their consent will be obtained.
Before the study, it will be ensured that the oral condition of the individual is not caused by any other factor (unknown systemic disease, blood disease, etc.). The individuals included in the study; systemic and oral anamnesis, smoking status, systemic disease status will be recorded and the following clinical measurements will be made.
Gingival crevicular fluid (GCF) samples will be taken from individuals suitable for the study model, and periodontal indices will be recorded. The levels of IL-10, IL-12 and IL-18 will be determined in the GCF samples taken. The researcher will not include individuals who have been included in other studies that have passed or will be approved by the ethics committee, and will not include individuals who will be included in this study, undertakes not to include it in its work.
Clinical measurements include Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Depth (PD), Free Gingival Margin (FGM), Clinical Attachment Level Measurement (CAL), Mobility parameters. The measurements were made by the same researcher from six different points of all teeth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal. It will be measured and recorded by a single person with the Williams (Hu-Friedy, USA) type periodontal probe. These measurements are non-invasive and will enable us to determine the periodontal status. After the clinical examination and measurements of the patients who met the inclusion criteria and signed the voluntary consent form, the gingival crevicular fluid samples to be taken from the patients will be analyzed and the results will be evaluated. Samples will be isolated from the gingival groove with the aid of absorbent paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) and biochemical analyzes will be made in the samples obtained by ELISA method in accordance with the protocols included in the kit. Biochemical analyzes will be carried out at Istanbul University, Istanbul Faculty of Medicine, Department of Medical Biochemistry.
The clinical evaluation methods planned to be applied in the study are listed below:
- Plaque Index
- Probing Depth
- Bleeding on Probing
- Clinical Attachment Level Measurement
- Free Gingival Margin
- Gingival Index
- Mobility Samples of paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) placed in the gingival groove will be placed in eppendorf tubes for laboratory examination in the session 1 week after the exact periodontal status is determined by periodontal measurements. Samples will be taken from areas with the deepest probable pocket depth. While obtaining gingival crevicular fluid samples, the area will be isolated with cotton pads and the microbial dental plaque on the tooth will be removed with cotton pellets, and then a short-term drying process will be done with air freshener from a 20 cm distance at a right angle. Then, standard absorbent 2x8 mm paper strips will be placed from the approximal regions to the entrance of the groove with slight resistance and after waiting for 30 seconds, each paper strip will be placed in an eppendorf tube and stored at -80°C. (New Brunswick Scientific Ultra Low Temperature Freezer). Samples will be taken from 6 teeth in each patient.
In case of bleeding from the gingival groove during sample collection, the sample will not be taken from that area.
GCF samples taken and stored at -80°C will be analyzed at Istanbul University, Istanbul Medical Faculty, Department of Medical Biochemistry. IL-10, IL-12 and IL-18 levels of GCF samples will be determined by ELISA method.
In the light of the data, the clinical conditions and biochemical analyzes of the patients will be compared and the relationship between them will be examined.
According to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions, an average of 11 units difference between the results obtained from interleukin biomarkers in the group of individuals with grade B-C stage III-IV periodontitis and healthy individuals, and a minimal sample to find the estimated 15-unit standard deviation significant size (assuming Type I error 5%, Type II error 20% assuming Power 0.80): 30 people for each group. Considering the wrong samples, 30+30 people will be taken into each group (30 healthy controls, 30 Periodontitis cases) Our study will be carried out on systemically healthy patients aged 18-65 years who were diagnosed with Grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions in the Periodontology Clinic of Istanbul University Faculty of Dentistry.
After the clinical examination and measurements of the patients who met the inclusion criteria and signed the voluntary consent form, the gingival crevicular fluid samples taken from the patients will be analyzed and the results will be evaluated. The samples will be isolated from the gingival crevicular with the help of the absorbent periopaper and biochemically analyzed with ELISA kits.
Periodontitis group:
- 18-65 years old
- Not having any systemic disease (diseases that do not affect the periodontal status)
- Non-smoker
- Have not received antibiotic treatment and/or used immunosuppressant medication in the last 6 months
- Have not received any periodontal treatment in the last 6 months
- No pregnancy and lactation
- Not using any medication regularly
- Having at least 20 teeth
- Grade B-C stage III-IV periodontal disease according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions
Healthy Group:
In patients who applied to Istanbul University Faculty of Dentistry, Department of Periodontology, periodontally healthy individuals who do not meet the above disease criteria, who do not have a history of periodontitis in any way, will be included in the study. Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grade B-C stage III-IV periodontitis group | – | Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)Grade B: Moderate Moderate bone loss is observed compared to biofilm and % Root Bone Loss/age 0.25 to 1.0 is determined as grade B. Stage III: Severe Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≤4. Grade C: Rapid Rapid bone loss is observed compared to biofilm and % Root Bone Loss/age >1.0 is determined as grade C. Stage IV:Advanced Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≥5. Need for complex rehabilition due to: Masticatory dysfunction, Secondary occlusal trauma(tooth mobility degree ≥2) Severe ridge defect,Bite collapse, drifting, flaring. Less than 20 remaining teeth (10 opposing pairs) |
| Healthy control group | – | Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In our study individuals who have Grade B-C stage III-IV periodontal disease according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions and individuals who have healthy gingiva will be selected
Key inclusion criteria (1 listed)
- •In patients who applied to Istanbul University Faculty of Dentistry, Department of Periodontology, periodontally healthy individuals who do not meet the above disease criteria, who do not have a history of periodontitis in any way, will be included in the study. Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.
Key exclusion criteria (6 listed)
- Those with systemic modifying disease affecting periodontal status
- Smoker
- Have received antibiotic therapy or immunosuppressive therapy in the last 6 months
- Previously received periodontal treatment in the last 6 months
- Pregnancy and breastfeeding status
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 |
|---|---|---|
| No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)No intervention was applied to the groups the samples will be collected in terms of the diagnosis (periodontitis, healthy) | Other | Grade B-C stage III-IV periodontitis group, Healthy control group |
Primary outcome
Measurement of GCF samples
Time frame: GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove
Measurement of IL-10, IL-12, IL-18 levels in GCF with grade B-C stage III-IV periodontitis individuals
1 secondary outcome
Measurement of GCF samples
Time frame: GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove
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 2 Oct 2023.
- Results publication: PubMed 29899423Geng Y, Li L, Wang X, He F, Zhou Y, Yang M, Xu Y. Interleukin-10 polymorphisms affect the key periodontal pathogens in Chinese periodontitis patients. Sci Rep. 2018 Jun 13;8(1):9068. doi: 10.1038/s41598-018-26236-4.
- Results publication: PubMed 32630798Borilova Linhartova P, Danek Z, Deissova T, Hromcik F, Lipovy B, Szaraz D, Janos J, Fassmann A, Bartova J, Drizhal I, Izakovicova Holla L. Interleukin Gene Variability and Periodontal Bacteria in Patients with Generalized Aggressive Form of Periodontitis. Int J Mol Sci. 2020 Jul 2;21(13):4728. doi: 10.3390/ijms21134728.
- Results publication: PubMed 16842511Orozco A, Gemmell E, Bickel M, Seymour GJ. Interleukin-1beta, interleukin-12 and interleukin-18 levels in gingival fluid and serum of patients with gingivitis and periodontitis. Oral Microbiol Immunol. 2006 Aug;21(4):256-60. doi: 10.1111/j.1399-302X.2006.00292.x.
- Results publication: PubMed 31761881Pai B S, Pradeep AR. Correlations between Interleukin-33 and -1alpha Levels in Gingival Crevicular Fluid and Plasma in Patients with Chronic or Aggressive Periodontitis and Disease-free Subjects. Bull Tokyo Dent Coll. 2019 Dec 10;60(4):279-289. doi: 10.2209/tdcpublication.2019-0002. Epub 2019 Nov 22.
- Results publication: PubMed 11422900Park AY, Scott P. Il-12: keeping cell-mediated immunity alive. Scand J Immunol. 2001 Jun;53(6):529-32. doi: 10.1046/j.1365-3083.2001.00917.x.
- Results publication: PubMed 1843338Clarke IJ, Tilbrook AJ, Galloway DB, Earl CR, Findlay JK, de Kretser DM. Inhibin in rams. J Reprod Fertil Suppl. 1991;43:163-70. No abstract available.
- Derived from this study: PubMed 39080003Cebesoy EI, Altaca M, Kocak-Oztug NA, Bingul I, Cifcibasi E. Associations between interleukin-10, -12, and - 18 and periodontal health and disease: a cross-sectional study. Clin Oral Investig. 2024 Jul 31;28(8):458. doi: 10.1007/s00784-024-05843-8.
- Individual participant dataSharing planned: No. Only clinical istatical analyses and GCF samples analyses will be shared
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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.
Emine Çifcibaşı, Assoc. Prof. principal investigator
Istanbul University
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, run by Istanbul University 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 1 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 2 Oct 2023. 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?
Measurement of GCF samples (time frame: GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove). 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 NCT05307068, 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 2 Oct 2023.