| CTRI Number |
CTRI/2025/08/092224 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
EVALUATION OF EFFICACY OF INTERLEUKIN 6 AS A MARKER TO DETERMINE THE SEVERITY OF PULP status |
|
Scientific Title of Study
|
Evaluation of efficacy of interleukin 6 as a diagnostic marker to determine the severity of pulpal inflammation |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Matta Navya |
| Designation |
Post graduate (2nd year student) |
| Affiliation |
anil neerukonda institute of dental sciences |
| Address |
Room No 7
Department of pediatric and preventive dentistry
Anil neerukonda institute of dental sciences
Visakhapatnam
Room No 7
Department of pediatric and preventive dentistry
Anil neerukonda institute of dental sciences
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
531163
India |
| Phone |
8328330343 |
| Fax |
|
| Email |
navyanavimatta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Chaitanya ram |
| Designation |
Professor and Head |
| Affiliation |
anil neerukonda institute of dental sciences |
| Address |
Room No 7
Department of pediatric and preventive dentistry
Anil neerukonda institute of dental sciences
Visakhapatnam
Room No 7
Department of pediatric and preventive dentistry
Anil neerukonda institute of dental sciences
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
531163
India |
| Phone |
9493120291 |
| Fax |
|
| Email |
fauchard2612@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MATTA NAVYA |
| Designation |
Post graduate (2nd year student) |
| Affiliation |
Anil neerukonda institute of dental sciences |
| Address |
Room No 7
Department of pediatric and preventive dentistry
Anil neerukonda institute of dental sciences
Visakhapatnam
Room No 7
Department of pediatric and preventive dentistry
Anil neerukonda institute of dental sciences
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
531163
India |
| Phone |
8328330343 |
| Fax |
|
| Email |
navyanavimatta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Matta Navya |
| Address |
Room No 7
Department of pediatric and preventive dentistry
Anil neerukonda institute of dental sciences
Visakhapatnam |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Matta Navya |
Anil neerukonda institute of dental sciences |
Room No 7
Department of pediatric and preventive dentistry
Anil neerukonda institute of dental sciences
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH |
8328330343
navyanavimatta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitional ethical committee -Anil neerukonda institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dental caries |
reversible pulpitis vs irreversible pulpitis interleukin 6 variability |
| Intervention |
interleukin 6 levels variability |
Evaluation of efficacy of interleukin 6 as a diagnostic marker to determine the severity of pulpal inflammation for reversible and irreversible pulpitis for a span of 1 month |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children with dental caries, aged between 6–14 years, with no underlying systemic diseases were included |
|
| ExclusionCriteria |
| Details |
Recent febrile illness, systemic conditions, and un-cooperative behavior were excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DIFFERENTIATE BETWEEN REVERSIBLE AND IRREVERSIBLE PULPITIS interms of interleukin 6 levels |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Background:
Pulpitis is an intricate inflammatory condition of the dental pulp,
predominantly caused by microbial irritation. The clinical diagnosis of
pulpitis categorized as either reversible or irreversible is typically based on
subjective assessments, including patient reported symptoms and radiographic
findings. However, these clinical evaluations may not always reflect the true
histopathological status of the pulp. Accurate diagnosis is critical for the
success of pulp therapy procedures. Emerging evidence suggests that
inflammatory molecular biomarkers, particularly those involved in the
pathogenesis of pulpitis, could serve as objective tools for assessing the
extent of pulpal inflammation. Among these, interleukin-6 (IL-6) has shown
promise as a diagnostic biomarker.
Aim:
The objective of this study was to evaluate whether salivary IL-6 levels could
be utilized as a supplementary diagnostic marker to determine the severity of
pulp inflammation in cases of deep dental caries.
Methodology:
The study included 10 paediatric patients, aged between 6 - 14 years,
presenting with deep carious lesions. Based on clinical examination,
radiographic examination five patients were diagnosed with reversible pulpitis
(RP) and five with irreversible pulpitis (IP). Stimulated whole saliva samples
were collected from the floor of the mouth. The concentration of IL-6 in these
samples was quantified using the Chemiluminescent Immunoassay (CLIA) method. An
independent sample t-test was conducted to analyse the statistical significance
of differences in IL-6 levels between the two groups.
Results:
IL-6 levels were found to be significantly elevated in the irreversible
pulpitis group compared to the reversible pulpitis group. The mean IL-6
concentration was 8.18 pg/mL in the reversible pulpitis group and 29.52 pg/mL
in the irreversible pulpitis group, indicating a marked distinction between the
two inflammatory states.
Conclusion:
The findings suggest that saliva may serve as a viable diagnostic medium for
assessing pulpal inflammation, especially in the presence of deep carious
lesions. Salivary IL-6 levels exhibited a strong discriminatory capacity
between reversible and irreversible pulpitis.
KEY
WORDS: Interleukin-6, salivary markers, reversible pulpitis,
irreversible pulpitis, inflammatory mediators |