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CTRI Number  CTRI/2024/12/077958 [Registered on: 11/12/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening
Dentistry 
Study Design  Other 
Public Title of Study   evaluation of saliva and blood levels of specific biomolecules in patients with gum disease and high blood sugar levels 
Scientific Title of Study   Comparative evaluation of salivary and serum Interleukin-38 levels in periodontitis subjects with and without type 2 diabetes mellitus following non-surgical periodontal therapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devapriya Appukuttan 
Designation  Professor 
Affiliation  SRM Dental College 
Address  Department of Periodontics, 3rd floor PG clinic, PG block, SRM Dental College, Ramapuram Campus, Chennai-600089

Chennai
TAMIL NADU
600089
India 
Phone  9840197121  
Fax    
Email  devapriyamds@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR D J Victor 
Designation  Professor and HOD 
Affiliation  SRM Dental College 
Address  Department of Periodontics, 3rd floor PG clinic, PG block, SRM Dental College, Ramapuram Campus, Chennai-600089

Chennai
TAMIL NADU
600089
India 
Phone  9841009952  
Fax    
Email  dr.djvictor@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR D J Victor 
Designation  Professor and HOD 
Affiliation  SRM Dental College 
Address  Department of Periodontics, 3rd floor PG clinic, PG block, SRM Dental College, Ramapuram Campus, Chennai-600089

Chennai
TAMIL NADU
600089
India 
Phone  9841009952  
Fax    
Email  dr.djvictor@gmail.com  
 
Source of Monetary or Material Support  
Out patient clinic, Department of periodontics, 3rd floor PG clinic, PG block, SRM Dental College, Ramapuram Campus, Chennai-600089 
 
Primary Sponsor  
Name  Dr Devapriya Appukuttan 
Address  Department of Periodontics, 3rd floor PG clinic, PG block, SRM Dental College, Ramapuram Campus, Chennai-600089 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Devapriya Appukuttan  SRM Dental College  Department of Periodontics, 3rd floor PG clinic, PG block, SRM Dental College, Ramapuram Campus, Chennai-600089
Chennai
TAMIL NADU 
9840197121

devapriyamds@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, SRM Dental College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Non-surgical periodontal therapy (NSPT)  After baseline sample collection, root surface debridement (NSPT) will be done and after 4 weeks of RSD, again the samples will be collected from the same individuals. 
Comparator Agent  Non-surgical Periodontal Therapy (NSPT)  Root surface debridement will be done in both the groups 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.systemically healthy patients
2.Patients with stage III grade C periodontitis
3.Patients with type II diabetes mellitus 
 
ExclusionCriteria 
Details  Exclusion criteria:
1.Patients under Immunosuppressants and or antibiotics and or anti-inflammatory
medications.
2.Pregnant or lactating mothers 
3.Current and past smokers 
4.Previous history of periodontal or orthodontic therapy.
5.Patients receiving iron replacement therapy for anemia. 
6.Patients with Uncontrolled diabetes mellitus
7. Patients with a history of any other systemic disease other than type 2 diabetes mellitus
8. Subjects not willing to participate and not willing to give consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To estimate the levels of IL-38 in the saliva and serum of periodontally
healthy, periodontitis patients with and without T2DM at baseline before
NSPT.
2. To estimate the levels of IL-38 in the saliva and serum of periodontitis
patients with and without T2DM post NSPT.
3. To estimate the changes in the saliva and serum level of IL-38 pre and post
NSPT in periodontitis patients with and without T2DM 
At baseline and after NSPT 
 
Secondary Outcome  
Outcome  TimePoints 
1. To correlate the saliva and serum levels of IL-38 with the clinical
parameters both at baseline and after NSPT in periodontitis patients with
and without T2DM.
2. To correlate between the serum and saliva levels of IL-38 in periodontally
healthy, periodontitis patients with and without T2DM
3. ROC analysis to evaluate the utility of IL-38 as a biomarker to
discriminate between periodontal health and disease in the presence and
absence of T2DM. 
At baseline and after NSPT 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/12/2024 
Date of Study Completion (India) 15/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
IL-38 is a member of the IL-1 superfamily. It is an anti-inflammatory cytokine
with protective role.It is involved in the pathogenesis of several diseases including
cardiovascular diseases, cerebrovascular disease, pulmonary disease, infectious
diseases , autoimmune diseases, Diabetes mellitus etc. It was first identified in
2001 from organs associated with immune response and has a molecular weight of
17kDa.The gene is located in the chromosome 2q13-14.1 clustered with the IL-1
family. The interleukin was previously referred to as IL-1F10 and IL-1HY2 and is
secreted by epithelial cells, monocytes, macrophages and immune cells. It lacks a
signal peptide hence secreted from the cells by different unknown mechanisms.
IL‐1R1, IL‐36R, and IL‐1RAPL1 are the main receptors of IL‐38. The
structure has 37% similarity to IL-1Ra and 41% similarity to IL-36Ra, by binding
to IL-1R1 and IL-36R it inhibits NF-KB, ERK, JNK, P38.It exists in 2 forms , the
full (aa 1-152) and the truncated form (aa 20-152). Proteases that are currently
unknown cleave the pre-cursor form at the N terminal end allowing activation.
Despite its largely anti-inflammatory role Pan et al, Mora et al, and Van de
Veerdonk et al have reported that IL-38, upregulated IL-6 and IL-22 levels
depending on the concentration, form (full length or truncated form), and the
presence of external stimuli. However, information available on this particular
biomolecule is minimal, preliminary, not definitive, necessitating further research
to fully understand its characteristics. 

In pulmonary diseases, IL-38 has anti-inflammatory and anti-fibrotic effect.
Likewise, it reduces neuroinflammation in neurodegenerative illnesses like
Alzheimer's. In 2023, Wei et al. showed that IL-38 suppressed macrophage-
mediated inflammation and decreased myocardial apoptosis by blocking the
activation of the NLRP3 inflammasome. In an attempt to combat obesity and
insulin resistance, it also suppresses preadipocyte differentiation by upregulating
GATA-3 expression, lowers triglyceride synthesis, and reduces adipocyte size.
Furthermore, it lowers the levels of Total Cholesterol, Triglycerides, and Low-
density lipoproteins as well as the production of IL-1β, IL-6, and Monocyte
chemotactic protein-1, which enhances lipid and glucose metabolism and lowers
the risk of cardiovascular diseases. According to de Graaf et al., overweight
people with a high risk of CVDs had considerably lower serum IL-38 levels than
healthy people. The above literature indicates the protective role of IL-38 in
cardiovascular system.

Huard et al,2023, Lauritano et al, 2023, reported that IL-38 plays an important
role in the pathogenesis of autoimmune diseases by inactivating immune cells and
inflammatory responses. It further, inhibits the release of inflammatory cytokines
and chemotaxis. Additionally, it promotes the activity of regulatory T cells to
suppress autoimmune responses. IL-38 also regulates the release of cytokines
secreted by Th1 and Th17 cells. Further, Yan Li et al in their study demonstrated
that IL-38 reduced the levels of GATA3, GLUT4, inflammatory cytokines like
IL-1b, IL-6, MCP-1, reduced the number of lipid droplets indicating its protective
role in inhibiting adipogenesis. Therefore, it can be inferred that IL-38 has a
predominantly anti-inflammatory role in the pathogenesis of multiple diseases.
The role of IL-38 in the pathogenesis of type 2 diabetes mellitus has been
investigated and discussed by few authors. Felicia Gurau et al, 2021 observed
considerably higher plasma concentrations of IL-38 in T2DM with and without
diabetic nephropathy patients. Likewise , shahad Nassurat et al in 2024, reported
upregulated serum levels of IL-38 in T2DM with and without diabetic neuropathy.
Similar trend in the IL-38 levels have been reported in gestational diabetes
mellitus and in children with T2DM. On the contrary, Tingqi Zhao et al, 2022,
observed reduced serum levels of IL-38 and negative correlation with IL-17 in
T2DM.The author suggested that IL-38 could be a marker for diagnosis of T2DM.
Furthermore, it has been suggested that IL-38 increases insulin sensitivity in
T2DM. However, the precise role and the pathways associated with this
biomolecule is unclear and needs to be explored in future studies.

Diabetes and Periodontitis share similar pathophysiology and diabetes is a risk
factor for periodontitis. The role of IL-38 in periodontitis has been investigated
only in two studies by Korkmaz et al, 2023 and Toraman & colleagues in 2024.
The former in their study demonstrated higher levels of salivary and serum IL-38
in the periodontitis group when compared with healthy and gingivitis group.
Salivary levels of IL-38 were higher in stage III, grade B and stage III, grade C
subjects when compared to periodontal health and gingivitis. Similarly, serum IL-
38 levels were higher in periodontitis group when compared to periodontal health
and gingivitis. Based on their results the authors concluded that IL-38 could be
used as a marker to identify periodontal disease activity. On the contrary,
Toraman & colleagues demonstrated reduced salivary levels of IL-38 in
periodontitis group when compared to periodontal health and gingivitis. The role
of IL-38 in periodontitis needs further clarity and the role of IL-38 in T2DM
associated periodontitis has never been studied till date and needs to be
investigated. Further the effect of non-surgical periodontal therapy (NSPT) on the
levels of IL-38 has never been studied. Hence, this study was carried out. We
hypothesis that the salivary and serum levels of IL-38 will be dysregulated in
T2DM associated periodontitis when compared with periodontal health. Further
treatment intervention by NSPT will alter IL-38 levels favorably towards
periodontal health.

The present study aims to evaluate the role of IL-38 in the pathogenesis of Type 2
Diabetes mellitus (T2DM) associated periodontitis, as well as to detect the
influence of NSPT on the serum and saliva levels of IL-38 to evaluate its utility as
a biomarker for T2DM associated periodontitis.
 
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