| CTRI Number |
CTRI/2025/07/091856 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of the relationship of blood sugar levels and salivary biochemical markers before and after tooth removal |
|
Scientific Title of Study
|
Correlation Between Salivary Immuno Biochemical Markers And Hb1ac in type 2 Diabetes subjects Before And After Dental Extraction. |
| 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 Larensh Kumar |
| Designation |
Post graduate student |
| Affiliation |
Institute of Dental Studies and Technologies Modinagar |
| Address |
Room no 3 Department of Oral And Maxillofacial Surgery Institute Of Dental Studies And Technologies Modinagar
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
7505454338 |
| Fax |
|
| Email |
lknager1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Mittal |
| Designation |
Professor & HOD |
| Affiliation |
Institute of Dental Studies and Technologies Modinagar |
| Address |
Department Of Oral And Maxillofacial Surgery Institute Of Dental Studies And Technologies Modinagar
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
7042166299 |
| Fax |
|
| Email |
dr.gauravmittal@idst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Mittal |
| Designation |
Professor & HOD |
| Affiliation |
Institute of Dental Studies and Technologies Modinagar |
| Address |
Department Of Oral And Maxillofacial Surgery Institute Of Dental Studies And Technologies Modinagar
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
7042166299 |
| Fax |
|
| Email |
dr.gauravmittal@idst.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial surgery.
Institute of Dental studies And Techhnologies,Modinagar. |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies and Technologies ,Modinagar |
| Address |
Delhi Meerut Road Kadrabad Modinagar Uttar Pardesh 201201 India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Larensh kumar |
Institute Of Dental Studies And Technologies Modinagar |
Room No.3, Department of Oral and Maxillofacial Surgery, IDST, Delhi Meerut Road Kadrabad Modinagar
Ghaziabad
UTTAR PRADESH |
7505454338
LKNAGER1991@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extraction of tooth,HBA1c salivary bio-chemical markers. |
Extraction of tooth,
blood investigations HBA1C
and Salivary Bio Markers in type 2 diabetic patient . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients Who require atleast one tooth extraction With a Definite Diagnosis of Type 2 Diabetes For At Least 3 Years With Glycated Hemoglobin Values Between 6.5% and 11%.
|
|
| ExclusionCriteria |
| Details |
Use of antibiotic or anti-inflammatory therapy in the last 3 months.
Any periodontal or orthodontic treatment in the last 6 months.
Periodontal disease stage 3 or 4.
Body mass index (BMI) 30, psychiatric disorders, pregnant or lactating women,
Smokers, systemic diseases that may interfere with the immune response, or with bone
metabolism (osteoporosis, rheumatoid arthritis, endocrine diseases, etc.)
Except for diabetes type 2.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Finding the Correlation Between Salivary Immuno Biochemical Markers And Hb1ac. |
Before Extraction And 3 Months After Extraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 2 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study demonstrates a significant correlation between salivary biochamical markers and Hba1c levels in type 2 diabetes subjects before after dental extraction. the finding suggest that
1 salivary biomarkers Certain biomarkers OPG RANKL TNF@ MMP9 IL18 in saliva may serve as potential indicators of glycemic control in type 2 diabetes patients.
2 Dental extraction impact dental extraction may influence salivary biochemical markers levels, potentially reflecting chenges in stress inflammation or glycemic control.
3 Hb1ac correlation The correlation between salivary biochemical markers and Hb1ac levels highlights the potential for salivary diagnostic to monitor glycemic control in type 2 diabetes patients.
CLINICAL IMPLICATION
1 Non invasive monitoring salivary biomarkers may offer a non invasive , convenient method for monitoring glycemic control
2 Dental care optimization Understanding the impact of dental procedure on salivary biochemical markers can help optimize dental care for type 2 diabetes patients.
|