PeriodontitisNCT05306860
IL-6, IL-17 and IL-35 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 an inflammatory disease characterized by periodontal tissue destruction caused by bacterial infection. The immune response plays an important role in the progression of periodontitis. 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-6, IL-17 and IL-35 Levels in the Gingival Crevicular Fluid of Individuals With Grade B-C Stage III-IV Periodontitis
Periodontitis is an inflammatory disease characterized by periodontal tissue destruction caused by bacterial infection. The immune response plays an important role in the progression of periodontitis. The disease process starts with periodontopathogens in dental plaque, and tissue destruction is mainly caused by the immune response of the host to the etiological microorganism and cytokine profile through various inflammatory cytokines. The cytokine response, which plays a critical role in the pathogenesis of periodontal disease, determines the progression of the disease.
Evaluation of the effects of IL-6, IL-17 and IL-35 levels in the gingival crevicular fluid on periodontal disease together with clinical parameters has been the basis of our study. This study consists of individuals with grad B-C stage III-IV periodontitis and healthy individuals, which is the subtitle of Periodontal and Periimplant Diseases and Conditions in the classification renewed in 2017.
It is aimed to examine the changes and possible correlations in IL-6, IL-17, IL-35 levels as a result of biochemical examination of the samples taken from the gingival crevicular fluid. In our study, according to the new classification of 2017, gingival crevicular fluid samples collected from individuals with grade B-C stage III-IV periodontal disease and healthy individuals under appropriate conditions and techniques were measured for IL-6, IL-17 and IL-35 by enzymatic immunosorbent test (ELISA). It aims to investigate the negative/positive correlations and compare the increases-decreases.
Read the detailed description
IL-35 is a next-generation signaling molecule belonging to the IL 12 cytokine family. It is produced by T-regulatory cells (Treg) consisting of the Α chain (p35). Recent studies have shown that IL-35 is an anti-inflammatory cytokine. It suppresses the immune response through Treg expansion and suppression of Th17 cell growth.
Interleukin-17 (IL-17) is a proinflammatory cytokine secreted by T-17 cells. It is a potent activator of neutrophils as it regulates G-CSF and receptor and chemokine expression. Its increased level has been documented in chronic periodontitis. In the presence of P. gingivalis, an increase in IL-17 and IL-23 is observed. Although periodontal infection (P. gingivalis) induces IL-17, a protective role of IL-17 against bone resorption has also been suggested. IL-17 produces IL-6, IL-8 by affecting fibroblasts.
IL-6 is produced by many cells in response to LPS and has both pro-inflammatory and anti-inflammatory roles. It is involved in inflammatory, regenerative, metabolic and neural processes. IL-6 level has been investigated in different studies in serum, saliva and gingival sulcus fluids. Studies with increased IL-6 levels in the gingival groove fluid in chronic periodontitis and studies with significant decreases in serum after nonsurgical treatment of chronic periodontitis have been reported. However, there are also studies that do not show a significant difference in the levels of various cytokines in the saliva of chronic periodontitis and healthy individuals.
Clinical measurements include Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Depth (PD), Clinical attachment level (CAL), Gingival margin position (DKK), and Mobility parameters. Measurements will be recorded from six different points of all teeth by the same investigator with a Williams-type periodontal probe (Hu-Friedy, USA).
- Healthy control groups: 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.
- Grade B-C / Stage III-IV periodontitis groups:
Grade B: Moderate rate of progression 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 periodontitis with potential for additional tooth loss 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 rate of progression Rapid bone loss is observed compared to biofilm and % Root Bone Loss/age >1.0 is determined as grade C.
Stage IV:Advanced periodontitis with extensive tooth loss and potential for loss of dentition 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)
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 before
- No pregnancy and breastfeeding status
- Not using any medication regularly
- Having at least 20 teeth
- Those with 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.
Samples of paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) placed in the gingival crevicular 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 probing depth. While obtaining gingival crevicular fluid samples, the area will be isolated with cotton pads, the microbial dental plaque on the tooth will be removed with cotton pellets, and a short-term drying process will be performed with air freshener from a distance of 20 cm at a right angle. Then, standard absorbent 2x8 mm paper strips will be placed from the approximal regions to the entrance of the crevicular with slight resistance and left for 30 seconds, then each paper strip will be placed in the same eppendorf tube for each patient and stored at -80°C. (New brunswick scientific ultra low temperature freezer). Samples will be taken from 4 teeth in each patient. In case of bleeding in the gingival crevicular during sample collection, the paper strip will be discarded. The samples will be isolated from the gingival crevicular with the help of absorbent paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) and biochemical analyzes will be made in the samples by ELISA method in accordance with the protocols included in the kit.
Descriptive data obtained in the study will be given as Mean ± Standard Deviation (median (min-max) for each group. Testing the Normality Assumption with Hypothesis Testing, Hypothesis Testing will be analyzed with Kolmogorov - Smirnov or Shapiro-Wilk tests.
The mean differences for each group in comparisons for the two groups in the analyses; t-test in independent groups in cases where the data show normal distribution, in cases where the data do not show normal distribution; Mann-Whitney U test will be used.
In more than two groups, One Way ANOVA will be used in cases where the data are normally distributed; Multiple comparisons will be made with the Tukey test. In cases where the data do not show normal distribution, Kruskal-Wallis H test will be analyzed, and multiple comparisons will be analyzed with the Non-Parametric S-N-K Method (Student Newman-Keuls Test). Statistical significance will be considered as p< 0.05 and two-way.
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).
- 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, stage III, stage IV, grade b, grade c
- 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-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-6, IL-17, IL-35 levels in GCF in 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-6, IL-17, IL-35 levels in GCF with systemically-periodontally healthy (H) 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 (6)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, Müge Ergün, Istanbul University
- Investigators
- Emine Çifcibaşı, Assoc.Prof., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306860
- Sponsor's protocol ID
- 679620
- Status last verified
- Mar 2024
- First submitted
- 24 Jan 2022
- Last updated
- 5 Mar 2024
- 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
Cekici A, Kantarci A, Hasturk H, Van Dyke TE. Inflammatory and immune pathways in the pathogenesis of periodontal disease. Periodontol 2000. 2014 Feb;64(1):57-80. doi: 10.1111/prd.12002.
PubMed 24320956Batool H, Nadeem A, Kashif M, Shahzad F, Tahir R, Afzal N. Salivary Levels of IL-6 and IL-17 Could Be an Indicator of Disease Severity in Patients with Calculus Associated Chronic Periodontitis. Biomed Res Int. 2018 Feb 18;2018:8531961. doi: 10.1155/2018/8531961. eCollection 2018.
PubMed 29670909Raj SC, Panda SM, Dash M, Patnaik K, Mohanty D, Katti N, Mahapatra A, Mishra D, Praharaj K. Association of Human Interleukin-35 Level in Gingival Crevicular Fluid and Serum in Periodontal Health, Disease, and after Nonsurgical Therapy: A Comparative Study. Contemp Clin Dent. 2018 Apr-Jun;9(2):293-297. doi: 10.4103/ccd.ccd_51_18.
PubMed 29875576Taniguchi T. Cytokine signaling through nonreceptor protein tyrosine kinases. Science. 1995 Apr 14;268(5208):251-5. doi: 10.1126/science.7716517.
PubMed 7716517Taubman MA, Yoshie H, Ebersole JL, Smith DJ, Olson CL. Host response in experimental periodontal disease. J Dent Res. 1984 Mar;63(3):455-60. doi: 10.1177/00220345840630031801.
PubMed 6607940Altaca M, Cebesoy EI, Kocak-Oztug NA, Bingul I, Cifcibasi E. Interleukin-6, -17, and -35 levels in association with clinical status in stage III and stage IV periodontitis: a cross-sectional study. BMC Oral Health. 2024 Aug 30;24(1):1015. doi: 10.1186/s12903-024-04751-3.
PubMed 39215253
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationships and Clinical Parameters Between IL-6, IL-17 and IL-35 Levels in the Gingival Crevicular Fluid of Individuals With Grade B-C Stage III-IV Periodontitis
- ClinicalTrials.gov ID
- NCT05306860
- Acronym / sponsor ID
- 679620
- Conditions
- Periodontitis
- Keywords
- periodontitis, healthy gingiva, stage III, stage IV, grade b, grade c
- 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 an inflammatory disease characterized by periodontal tissue destruction caused by bacterial infection. The immune response plays an important role in the progression of periodontitis. The disease process starts with periodontopathogens in dental plaque, and tissue destruction is mainly caused by the immune response of the host to the etiological microorganism and cytokine profile through various inflammatory cytokines. The cytokine response, which plays a critical role in the pathogenesis of periodontal disease, determines the progression of the disease.
Evaluation of the effects of IL-6, IL-17 and IL-35 levels in the gingival crevicular fluid on periodontal disease together with clinical parameters has been the basis of our study. This study consists of individuals with grad B-C stage III-IV periodontitis and healthy individuals, which is the subtitle of Periodontal and Periimplant Diseases and Conditions in the classification renewed in 2017.
It is aimed to examine the changes and possible correlations in IL-6, IL-17, IL-35 levels as a result of biochemical examination of the samples taken from the gingival crevicular fluid. In our study, according to the new classification of 2017, gingival crevicular fluid samples collected from individuals with grade B-C stage III-IV periodontal disease and healthy individuals under appropriate conditions and techniques were measured for IL-6, IL-17 and IL-35 by enzymatic immunosorbent test (ELISA). It aims to investigate the negative/positive correlations and compare the increases-decreases.
Detailed description
IL-35 is a next-generation signaling molecule belonging to the IL 12 cytokine family. It is produced by T-regulatory cells (Treg) consisting of the Α chain (p35). Recent studies have shown that IL-35 is an anti-inflammatory cytokine. It suppresses the immune response through Treg expansion and suppression of Th17 cell growth.
Interleukin-17 (IL-17) is a proinflammatory cytokine secreted by T-17 cells. It is a potent activator of neutrophils as it regulates G-CSF and receptor and chemokine expression. Its increased level has been documented in chronic periodontitis. In the presence of P. gingivalis, an increase in IL-17 and IL-23 is observed. Although periodontal infection (P. gingivalis) induces IL-17, a protective role of IL-17 against bone resorption has also been suggested. IL-17 produces IL-6, IL-8 by affecting fibroblasts.
IL-6 is produced by many cells in response to LPS and has both pro-inflammatory and anti-inflammatory roles. It is involved in inflammatory, regenerative, metabolic and neural processes. IL-6 level has been investigated in different studies in serum, saliva and gingival sulcus fluids. Studies with increased IL-6 levels in the gingival groove fluid in chronic periodontitis and studies with significant decreases in serum after nonsurgical treatment of chronic periodontitis have been reported. However, there are also studies that do not show a significant difference in the levels of various cytokines in the saliva of chronic periodontitis and healthy individuals.
Clinical measurements include Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Depth (PD), Clinical attachment level (CAL), Gingival margin position (DKK), and Mobility parameters. Measurements will be recorded from six different points of all teeth by the same investigator with a Williams-type periodontal probe (Hu-Friedy, USA).
- Healthy control groups: 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.
- Grade B-C / Stage III-IV periodontitis groups:
Grade B: Moderate rate of progression 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 periodontitis with potential for additional tooth loss 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 rate of progression Rapid bone loss is observed compared to biofilm and % Root Bone Loss/age >1.0 is determined as grade C.
Stage IV:Advanced periodontitis with extensive tooth loss and potential for loss of dentition 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)
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 before
- No pregnancy and breastfeeding status
- Not using any medication regularly
- Having at least 20 teeth
- Those with 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.
Samples of paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) placed in the gingival crevicular 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 probing depth. While obtaining gingival crevicular fluid samples, the area will be isolated with cotton pads, the microbial dental plaque on the tooth will be removed with cotton pellets, and a short-term drying process will be performed with air freshener from a distance of 20 cm at a right angle. Then, standard absorbent 2x8 mm paper strips will be placed from the approximal regions to the entrance of the crevicular with slight resistance and left for 30 seconds, then each paper strip will be placed in the same eppendorf tube for each patient and stored at -80°C. (New brunswick scientific ultra low temperature freezer). Samples will be taken from 4 teeth in each patient. In case of bleeding in the gingival crevicular during sample collection, the paper strip will be discarded. The samples will be isolated from the gingival crevicular with the help of absorbent paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) and biochemical analyzes will be made in the samples by ELISA method in accordance with the protocols included in the kit.
Descriptive data obtained in the study will be given as Mean ± Standard Deviation (median (min-max) for each group. Testing the Normality Assumption with Hypothesis Testing, Hypothesis Testing will be analyzed with Kolmogorov - Smirnov or Shapiro-Wilk tests.
The mean differences for each group in comparisons for the two groups in the analyses; t-test in independent groups in cases where the data show normal distribution, in cases where the data do not show normal distribution; Mann-Whitney U test will be used.
In more than two groups, One Way ANOVA will be used in cases where the data are normally distributed; Multiple comparisons will be made with the Tukey test. In cases where the data do not show normal distribution, Kruskal-Wallis H test will be analyzed, and multiple comparisons will be analyzed with the Non-Parametric S-N-K Method (Student Newman-Keuls Test). Statistical significance will be considered as p< 0.05 and two-way.
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).
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-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) |
| 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-6, IL-17, IL-35 levels in GCF in 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 5 Mar 2024.
- Results publication: PubMed 24320956Cekici A, Kantarci A, Hasturk H, Van Dyke TE. Inflammatory and immune pathways in the pathogenesis of periodontal disease. Periodontol 2000. 2014 Feb;64(1):57-80. doi: 10.1111/prd.12002.
- Results publication: PubMed 29670909Batool H, Nadeem A, Kashif M, Shahzad F, Tahir R, Afzal N. Salivary Levels of IL-6 and IL-17 Could Be an Indicator of Disease Severity in Patients with Calculus Associated Chronic Periodontitis. Biomed Res Int. 2018 Feb 18;2018:8531961. doi: 10.1155/2018/8531961. eCollection 2018.
- Results publication: PubMed 29875576Raj SC, Panda SM, Dash M, Patnaik K, Mohanty D, Katti N, Mahapatra A, Mishra D, Praharaj K. Association of Human Interleukin-35 Level in Gingival Crevicular Fluid and Serum in Periodontal Health, Disease, and after Nonsurgical Therapy: A Comparative Study. Contemp Clin Dent. 2018 Apr-Jun;9(2):293-297. doi: 10.4103/ccd.ccd_51_18.
- Results publication: PubMed 7716517Taniguchi T. Cytokine signaling through nonreceptor protein tyrosine kinases. Science. 1995 Apr 14;268(5208):251-5. doi: 10.1126/science.7716517.
- Results publication: PubMed 6607940Taubman MA, Yoshie H, Ebersole JL, Smith DJ, Olson CL. Host response in experimental periodontal disease. J Dent Res. 1984 Mar;63(3):455-60. doi: 10.1177/00220345840630031801.
- Derived from this study: PubMed 39215253Altaca M, Cebesoy EI, Kocak-Oztug NA, Bingul I, Cifcibasi E. Interleukin-6, -17, and -35 levels in association with clinical status in stage III and stage IV periodontitis: a cross-sectional study. BMC Oral Health. 2024 Aug 30;24(1):1015. doi: 10.1186/s12903-024-04751-3.
- 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 5 Mar 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?
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 NCT05306860, which also lists 6 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 5 Mar 2024.