Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06135532
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-11-11
Brief Title:
Chemerin Fetuin-A IL-34 and IL-13 Levels in Diabetic Periodontitis Patients
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Effect of Non-surgical Periodontal Treatment on Chemerin Fetuin-A IL-34 and IL-13 Levels in Type 2 Diabetic Periodontitis Patients
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study aimed to assess the effect of non-surgical periodontal treatment on serum and salivary chemerin fetuin-A IL-34 and IL-13 levels in periodontitis with and without diabetes mellitus DM type 2 22 non-periodontitis 22 non-periodontitis with DM 22 Stage IIIIV Grade C periodontitis 22 tage IIIIV Grade C periodontitis with well-controlled DM and 22 tage IIIIV Grade C periodontitis with poorly-controlled DM patients were enrolled At baseline serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded from all subjects Periodontitis patients received non-surgical periodontal therapy Clinical parameters were re-measured and samples were re-collected 1 and 3 months after therapy from periodontitis patients Serum and salivary protein levels were analyzed by ELISA Data were analyzed using appropriate statistical tests
Detailed Description:
Type 2 diabetes T2DM increases the risk for severe periodontal disease by three times making it a risk factor for the progression of periodontitis Periodontitis works as a focus of local infection and a source of low-grade chronic inflammation Periodontal therapy primarily targets the microbial component of the disease by mechanical debridement of tooth surfaces
Chemerin an adipose tissue-specific adipokine influences the glucose pathway lipid metabolism inflammation levels chemotaxis of immature dendritic cells and integration of macrophage-phagocytic activity to extracellular matrix proteins and adhesion molecules Fetuin-A impedes insulin receptor tyrosine kinase thus affiliated with insulin resistance metabolic syndrome and an increased risk for type 2 diabetes mellitus Interleukin IL-34 modulates myeloid cell differentiation proliferation and survival Depending on the microenvironment IL-34 can transform circulating monocytes into specific non-resident macrophages with a pro-inflammatory M1 phenotype or an anti-inflammatory M2 phenotype IL-13 inhibits the release of inflammatory cytokines such as IL-1 IL-6 and TNF-α from monocytes and macrophages
This study is the first controlled clinical study that examines the levels of chemerin fetuin-A IL-34 and IL-13 in saliva and serum in periodontitis with and without T2DM well-controlled and poorly-controlled T2DM and evaluates the situation before and after the treatment The first hypothesis of this study is that in periodontitis groups chemerin and IL-34 levels will be high in saliva and serum and IL-13 and fetuin-A levels will be low in contrast to the non-periodontitis groups The second hypothesis of this study is that in T2DM groups fetuin-A and chemerin levels will be high compared to participants without T2DM The third hypothesis of this study after periodontal treatment chemein and IL-34 levels will decrease and IL-13 and fetuin-A will increase in saliva and serum Based on these hypotheses the study aims to compare the levels of chemerin fetuin-A IL-34 and IL-13 in saliva and serum of nonperiodontitis controls NP NP with T2DM DMNP periodontitis P P with well-controlled T2DM WDMP and P with poorly-controlled T2DM PDMP subjects and to evaluate the effect of periodontal treatment
A total of 110 participants 22 NP 22 DMNP 22 P 22 WDMP and 22 PDMP were included in this study The whole mouth clinical periodontal examination included measurement of probing depth PPD clinical attachment level CAL presence of bleeding on probing BOP gingival index GI and plaque index PI at 6 sites per tooth except the third molars The presence and type of the alveolar bone loss were assessed on the digital panoramic radiograph in each participant which was supplemented with periapical radiographs if necessary
The periodontal status of each patient was evaluated by a single calibrated periodontist with a manual probe The diagnosis of periodontitis or periodontally health was determined according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions NP individuals healthy and gingivitis n22 in the control group had no sites with PD 3 mm and CAL 2 mm and no radiographic evidence of alveolar bone loss NP group also exhibited no history of periodontitis The periodontitis stage IIIIV patients had a minimum of three teeth apart from the first molars and incisors showing CAL 5 mm and PD 6 mm Radiographic bone loss extending from coronal to middle third or beyond Bone loss age was higher than 10
The diagnosis of patients with T2DM was based on the criteria given by the World Health Organization Both well-controlled and poorly-controlled diabetic patients diagnosed at least one year ago as having T2DM and treated with oral anti-diabetics andor insulin no major diabetic complications retinopathy nephropathy neuropathy were included
Treatment
The recruited periodontitis patients received conventional quadrant scaling and root planning SRP under local anesthesia in a total of 4 sessions in four weeks SRP was performed by the same periodontist using ultrasonic inserts and manual periodontal curettes Re-evaluations were performed at 1 and 3 months following the completion of the SRP No periodontal intervention was carried out in the non-periodontitis controls
Saliva and serum Sampling A total of 5 mL of unstimulated whole saliva was collected by passive drool method between 900 and 1000 am The participants were advised to avoid food consumption for three hours before sample collection The participants were seated upright and saliva was collected over 5 minutes with instructions to pool saliva in the floor of the mouth and passively drool it into a sterile glass beaker Then saliva samples are immediately transferred to a 2 mL polypropylene tube and stored at -80C A total of 105 mL of blood was collected from the antecubital fossa by the venepuncture method Serum was isolated from the blood by centrifuging at 4000 rpm for 12 minutes followed by its rapid transfer to a sterile polypropylene tube and storage at -80C
Biomarker Immunoassays Saliva and serum samples were thawed on ice The saliva samples were centrifuged at 5000 rpm for 15 minutes at room temperature and supernatants were immediately used for assays Using commercial kits serum and salivary samples of chemerin fetuin-A IL-34 and IL-13 were measured by ELISA
Statistical Analysis Shapiro Wilks normality test was applied to determine the clinical and biochemical data distribution Nonparametric tests were used because the variables did not follow a normal distribution The gender distributions among groups were analyzed using the Chi-Square test Multiple comparisons of the clinical and biochemical parameters were analyzed using the Kruskal-Wallis if significance occurred the Bonferroni-adjusted Mann-Whitney U test was applied for paired comparisons Intragroup comparisons were performed using the Wilcoxon signed-rank test The correlations among clinical and biochemical parameters at baseline were performed using Spearmans rank correlation analysis Multinomial logistic regression was used to determine associations between periodontitis groups and biochemical parameters The level of significance was set at P 005
Chemerin an adipose tissue-specific adipokine influences the glucose pathway lipid metabolism inflammation levels chemotaxis of immature dendritic cells and integration of macrophage-phagocytic activity to extracellular matrix proteins and adhesion molecules Fetuin-A impedes insulin receptor tyrosine kinase thus affiliated with insulin resistance metabolic syndrome and an increased risk for type 2 diabetes mellitus Interleukin IL-34 modulates myeloid cell differentiation proliferation and survival Depending on the microenvironment IL-34 can transform circulating monocytes into specific non-resident macrophages with a pro-inflammatory M1 phenotype or an anti-inflammatory M2 phenotype IL-13 inhibits the release of inflammatory cytokines such as IL-1 IL-6 and TNF-α from monocytes and macrophages
This study is the first controlled clinical study that examines the levels of chemerin fetuin-A IL-34 and IL-13 in saliva and serum in periodontitis with and without T2DM well-controlled and poorly-controlled T2DM and evaluates the situation before and after the treatment The first hypothesis of this study is that in periodontitis groups chemerin and IL-34 levels will be high in saliva and serum and IL-13 and fetuin-A levels will be low in contrast to the non-periodontitis groups The second hypothesis of this study is that in T2DM groups fetuin-A and chemerin levels will be high compared to participants without T2DM The third hypothesis of this study after periodontal treatment chemein and IL-34 levels will decrease and IL-13 and fetuin-A will increase in saliva and serum Based on these hypotheses the study aims to compare the levels of chemerin fetuin-A IL-34 and IL-13 in saliva and serum of nonperiodontitis controls NP NP with T2DM DMNP periodontitis P P with well-controlled T2DM WDMP and P with poorly-controlled T2DM PDMP subjects and to evaluate the effect of periodontal treatment
A total of 110 participants 22 NP 22 DMNP 22 P 22 WDMP and 22 PDMP were included in this study The whole mouth clinical periodontal examination included measurement of probing depth PPD clinical attachment level CAL presence of bleeding on probing BOP gingival index GI and plaque index PI at 6 sites per tooth except the third molars The presence and type of the alveolar bone loss were assessed on the digital panoramic radiograph in each participant which was supplemented with periapical radiographs if necessary
The periodontal status of each patient was evaluated by a single calibrated periodontist with a manual probe The diagnosis of periodontitis or periodontally health was determined according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions NP individuals healthy and gingivitis n22 in the control group had no sites with PD 3 mm and CAL 2 mm and no radiographic evidence of alveolar bone loss NP group also exhibited no history of periodontitis The periodontitis stage IIIIV patients had a minimum of three teeth apart from the first molars and incisors showing CAL 5 mm and PD 6 mm Radiographic bone loss extending from coronal to middle third or beyond Bone loss age was higher than 10
The diagnosis of patients with T2DM was based on the criteria given by the World Health Organization Both well-controlled and poorly-controlled diabetic patients diagnosed at least one year ago as having T2DM and treated with oral anti-diabetics andor insulin no major diabetic complications retinopathy nephropathy neuropathy were included
Treatment
The recruited periodontitis patients received conventional quadrant scaling and root planning SRP under local anesthesia in a total of 4 sessions in four weeks SRP was performed by the same periodontist using ultrasonic inserts and manual periodontal curettes Re-evaluations were performed at 1 and 3 months following the completion of the SRP No periodontal intervention was carried out in the non-periodontitis controls
Saliva and serum Sampling A total of 5 mL of unstimulated whole saliva was collected by passive drool method between 900 and 1000 am The participants were advised to avoid food consumption for three hours before sample collection The participants were seated upright and saliva was collected over 5 minutes with instructions to pool saliva in the floor of the mouth and passively drool it into a sterile glass beaker Then saliva samples are immediately transferred to a 2 mL polypropylene tube and stored at -80C A total of 105 mL of blood was collected from the antecubital fossa by the venepuncture method Serum was isolated from the blood by centrifuging at 4000 rpm for 12 minutes followed by its rapid transfer to a sterile polypropylene tube and storage at -80C
Biomarker Immunoassays Saliva and serum samples were thawed on ice The saliva samples were centrifuged at 5000 rpm for 15 minutes at room temperature and supernatants were immediately used for assays Using commercial kits serum and salivary samples of chemerin fetuin-A IL-34 and IL-13 were measured by ELISA
Statistical Analysis Shapiro Wilks normality test was applied to determine the clinical and biochemical data distribution Nonparametric tests were used because the variables did not follow a normal distribution The gender distributions among groups were analyzed using the Chi-Square test Multiple comparisons of the clinical and biochemical parameters were analyzed using the Kruskal-Wallis if significance occurred the Bonferroni-adjusted Mann-Whitney U test was applied for paired comparisons Intragroup comparisons were performed using the Wilcoxon signed-rank test The correlations among clinical and biochemical parameters at baseline were performed using Spearmans rank correlation analysis Multinomial logistic regression was used to determine associations between periodontitis groups and biochemical parameters The level of significance was set at P 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None