Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962567
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-05-12
Brief Title:
Interleukin-34 Level in Periodontal Disease
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Effect of Non-surgical Periodontal Therapy on Interleukin-34 Level in Gingival Crevicular Fluid in Patients With Periodontal Disease Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-07
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:
Aim of the study
1 To investigate changes in the levels of Interleukin 34 IL-34 in the Gingival crevicular fluidGCF of patients with stage II periodontitis patients before and after nonsurgical periodontal therapy and compare it with healthy individuals
2 To correlate changes in Gingival crevicular fluid level of Interleukin 34 with changes in periodontal parameters after nonsurgical periodontal therapy
1 To investigate changes in the levels of Interleukin 34 IL-34 in the Gingival crevicular fluidGCF of patients with stage II periodontitis patients before and after nonsurgical periodontal therapy and compare it with healthy individuals
2 To correlate changes in Gingival crevicular fluid level of Interleukin 34 with changes in periodontal parameters after nonsurgical periodontal therapy
Detailed Description:
Periodontal disease is a chronic disease of various inflammatory diseases where the early symptoms are gingival redness swelling and bleeding As the disease progresses periodontal pockets clinical attachment loss CAL as well as alveolar bone resorption may occur If left untreated periodontal disease can lead to loss of teeth which directly affects patients mastication
A new system of periodontal classification has been adopted in which the types of disease that were previously identified as chronic or aggressive Armitage 1999 are now classified under one category periodontitis and re-diagnosed on the basis of many variants staging and grading system
The stage is based on the severity of the disease and the complexity of the disease management in terms of loss of clinical attachment between teeth CAL radiographic bone loss and tooth loss complexity and size and distribution Grading provides additional information about the biological features of the disease including history-based analysis of the progression rate of periodontitis progression risk assessment analysis of possible adverse effects of treatment and risk assessment that the disease or its treatment may adversely affect the patients normal life
Periodontitis is described in four stages ranging from Stage I Initial periodontitis CAL 1-2mm Stage II Moderate periodontitis CAL 3-4 mm Stage III Severe periodontitis with potential for additional tooth loss 4 andCAL5mm Stage IV Severe periodontitis with potential for loss of dentition 5 and CAL5mm Grading focuses on assessing risk factors like smoking diabetes and outcomes of scaling and root debridement Grade A Slow rate of progression no CAL loss over 5 years Grade B Moderate rate of progression CAL loss2mm over 5years and Grade C Rapid rate of progression CAL loss 2 mm over 5 years
Periodontitis occurs due to a complex of genetic environmental and bacterial interaction in which bacterial and host factors play an important role The imbalance between the previous two factors results in a completely different change from health state to inflammatory disease and once inflammation has begun activation of many cytokines and molecular mechanisms occur
Cytokines are defined as soluble small proteins 5-20 kDa which bind to specific receptors on certain cells stimulate some internal cellular changes and cause multiple genetic and chemical regulations While molecular mechanisms activate the host-derived proteinase that allow the loss of the marginal periodontal ligament fibers the migration of the junctional epithelium apically and the proliferation of bacterial biofilm on the root surface
There are two different types of inflammatory cytokines proinflammatory cytokines that is involved in inflammatory reactions including IL-1β IL-6 IL-12 TNF-α and anti-inflammatory cytokines that regulate or control the pro-inflammatory cytokine response including IL-4 Interleukin-1 receptor antagonist IL-1RA and IL-10
Scaling and root debridement NSPT aimed at mechanical removal of bacterial plaque from the tooth surface is considered the gold standard This procedure decreases the number of Gram-negative bacteria in favor of Gram-positive bacteria as well as reduces the overall number of microorganisms in periodontal pockets and decrease amount of proinflammatory cytokines
Traditional clinical periodontal diagnostic parameters used include probing depths bleeding on probing clinical attachment levels plaque index and radiographs assessing alveolar bone level They are limited in that only disease history not current disease status can be assessed
Recent methods in oral and periodontal disease diagnostic research are identifying periodontal risk which is quantified by objective measures like biomarkers which are diagnostic tools to measure periodontal disease at the molecular cellular tissue and clinical levels
There are many bone resorption biomarkers such as receptor activator nuclear factor kappa B RANKL a tumor necrosis factor TNF family cytokine as well as on macrophage colony-stimulating factor M-CSF M-CSF is required for osteoclastogenesis stimulating both adhesion and proliferation of osteoclast precursors The novel cytokine interleukin 34 IL-34 is the second active component of colony-stimulating factor receptor CSF-1R IL-34 was shown to stimulate monocyte activation and colonization of macrophages from bone marrow cells
IL-34 messenger RNA mRNA is expressed in a number of tissues including the heart brain lungs liver kidneys spleen thymus testes ovary small intestine prostate and colon as well as -spleen
IL-34 plays an important role in RANKL-induced osteoclastogenesis Inhibition of the CSF-1 receptor by IL-34 has been shown to reduce alveolar bone loss in a periodontal rat model highlighting their role in periodontal pathology
The diagnostic potential of gingival crevicular fluid GCF has been evaluated from confirming health and disease status to recent predictive tool It distinguishes between healthy sites of diseased individuals and healthy sites of periodontally healthy people in the microbial profile and the concentration and formation of molecular biomarkers and therefore predicts patient-or-site-based disease Study in 2018 reported that estimation of IL-34 level detects high-risk individuals with periodontitis and systemic diseases such as diabetes as high levels of IL-34 in gingival crevicular fluid GCF and plasma of patients with chronic periodontitis further increased when accompanied with type 2 diabetes mellitus T2DM IL-34 can be considered a potential inflammatory biomarker of periodontal disease as GCF IL-34 levels was high in patients with periodontitis and decreased after NSPT
On the other hand salivary levels of IL-34 were significantly lower in the periodontitis group compared to both healthy groups and gingivitis After receiving non-surgical periodontal treatment at 3 and 6 months post-treatment IL-34 significantly increased 3 months after treatment compared with baseline
Therefore Further studies must be carried out to confirm these findings and to better understand the possible role of IL-34 in the pathogenesis of periodontal diseases and to evaluate its levels in GCF in patients with periodontal disease after non-surgical periodontal treatment NSPT
A new system of periodontal classification has been adopted in which the types of disease that were previously identified as chronic or aggressive Armitage 1999 are now classified under one category periodontitis and re-diagnosed on the basis of many variants staging and grading system
The stage is based on the severity of the disease and the complexity of the disease management in terms of loss of clinical attachment between teeth CAL radiographic bone loss and tooth loss complexity and size and distribution Grading provides additional information about the biological features of the disease including history-based analysis of the progression rate of periodontitis progression risk assessment analysis of possible adverse effects of treatment and risk assessment that the disease or its treatment may adversely affect the patients normal life
Periodontitis is described in four stages ranging from Stage I Initial periodontitis CAL 1-2mm Stage II Moderate periodontitis CAL 3-4 mm Stage III Severe periodontitis with potential for additional tooth loss 4 andCAL5mm Stage IV Severe periodontitis with potential for loss of dentition 5 and CAL5mm Grading focuses on assessing risk factors like smoking diabetes and outcomes of scaling and root debridement Grade A Slow rate of progression no CAL loss over 5 years Grade B Moderate rate of progression CAL loss2mm over 5years and Grade C Rapid rate of progression CAL loss 2 mm over 5 years
Periodontitis occurs due to a complex of genetic environmental and bacterial interaction in which bacterial and host factors play an important role The imbalance between the previous two factors results in a completely different change from health state to inflammatory disease and once inflammation has begun activation of many cytokines and molecular mechanisms occur
Cytokines are defined as soluble small proteins 5-20 kDa which bind to specific receptors on certain cells stimulate some internal cellular changes and cause multiple genetic and chemical regulations While molecular mechanisms activate the host-derived proteinase that allow the loss of the marginal periodontal ligament fibers the migration of the junctional epithelium apically and the proliferation of bacterial biofilm on the root surface
There are two different types of inflammatory cytokines proinflammatory cytokines that is involved in inflammatory reactions including IL-1β IL-6 IL-12 TNF-α and anti-inflammatory cytokines that regulate or control the pro-inflammatory cytokine response including IL-4 Interleukin-1 receptor antagonist IL-1RA and IL-10
Scaling and root debridement NSPT aimed at mechanical removal of bacterial plaque from the tooth surface is considered the gold standard This procedure decreases the number of Gram-negative bacteria in favor of Gram-positive bacteria as well as reduces the overall number of microorganisms in periodontal pockets and decrease amount of proinflammatory cytokines
Traditional clinical periodontal diagnostic parameters used include probing depths bleeding on probing clinical attachment levels plaque index and radiographs assessing alveolar bone level They are limited in that only disease history not current disease status can be assessed
Recent methods in oral and periodontal disease diagnostic research are identifying periodontal risk which is quantified by objective measures like biomarkers which are diagnostic tools to measure periodontal disease at the molecular cellular tissue and clinical levels
There are many bone resorption biomarkers such as receptor activator nuclear factor kappa B RANKL a tumor necrosis factor TNF family cytokine as well as on macrophage colony-stimulating factor M-CSF M-CSF is required for osteoclastogenesis stimulating both adhesion and proliferation of osteoclast precursors The novel cytokine interleukin 34 IL-34 is the second active component of colony-stimulating factor receptor CSF-1R IL-34 was shown to stimulate monocyte activation and colonization of macrophages from bone marrow cells
IL-34 messenger RNA mRNA is expressed in a number of tissues including the heart brain lungs liver kidneys spleen thymus testes ovary small intestine prostate and colon as well as -spleen
IL-34 plays an important role in RANKL-induced osteoclastogenesis Inhibition of the CSF-1 receptor by IL-34 has been shown to reduce alveolar bone loss in a periodontal rat model highlighting their role in periodontal pathology
The diagnostic potential of gingival crevicular fluid GCF has been evaluated from confirming health and disease status to recent predictive tool It distinguishes between healthy sites of diseased individuals and healthy sites of periodontally healthy people in the microbial profile and the concentration and formation of molecular biomarkers and therefore predicts patient-or-site-based disease Study in 2018 reported that estimation of IL-34 level detects high-risk individuals with periodontitis and systemic diseases such as diabetes as high levels of IL-34 in gingival crevicular fluid GCF and plasma of patients with chronic periodontitis further increased when accompanied with type 2 diabetes mellitus T2DM IL-34 can be considered a potential inflammatory biomarker of periodontal disease as GCF IL-34 levels was high in patients with periodontitis and decreased after NSPT
On the other hand salivary levels of IL-34 were significantly lower in the periodontitis group compared to both healthy groups and gingivitis After receiving non-surgical periodontal treatment at 3 and 6 months post-treatment IL-34 significantly increased 3 months after treatment compared with baseline
Therefore Further studies must be carried out to confirm these findings and to better understand the possible role of IL-34 in the pathogenesis of periodontal diseases and to evaluate its levels in GCF in patients with periodontal disease after non-surgical periodontal treatment NSPT
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