| CTRI Number |
CTRI/2025/10/095597 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of gum inflammation and blood sugar levels in people with gingivitis and periodontitis |
|
Scientific Title of Study
|
Effect of periodontal inflammation on gingival crevicular and finger prick blood glucose in gingivitis and periodontitis groups: a cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ivaturi Naga Surya Akhila |
| Designation |
Post Graduate |
| Affiliation |
Gsl Dental College Rajahmundry |
| Address |
Room number-10 ,Department of Periodontics ,GSL Dental College ,Rajahmundry ,East Godavari ,Andhra Pradesh ,India
Room number -10 ,Department of Periodontics ,GSL Dental College ,Rajahmundry ,East Godavari ,Andhra Pradesh ,India
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
7032914895 |
| Fax |
|
| Email |
insakhila2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupama Masapu |
| Designation |
Professor and head of the department |
| Affiliation |
Gsl Dental College Rajahmundry |
| Address |
Room number-10 ,Department of Periodontics ,GSL Dental College ,Rajahmundry ,East Godavari ,Andhra Pradesh ,India
Room number-10 ,Department of Periodontics ,GSL Dental College ,Rajahmundry ,East Godavari ,Andhra Pradesh ,India
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9985313267 |
| Fax |
|
| Email |
anu3267@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupama Masapu |
| Designation |
Professor and head of the department |
| Affiliation |
Gsl Dental College Rajahmundry |
| Address |
Room number-10 ,Department of Periodontics ,GSL Dental College ,Rajahmundry ,East Godavari ,Andhra Pradesh ,India
Room number-10 ,Department of Periodontics ,GSL Dental College ,Rajahmundry ,East Godavari ,Andhra Pradesh ,India
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9985313267 |
| Fax |
|
| Email |
anu3267@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number -10 ,Department of Periodontics ,GSL dental college ,Rajahmundry ,Andhra
pradesh ,533296,India |
|
|
Primary Sponsor
|
| Name |
Ivaturi Naga Surya Akhila |
| Address |
Room number -10 ,Department of Periodontics ,GSL dental college ,Rajahmundry ,Andhra
pradesh ,533296,India |
| 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 Ivaturi Naga Surya Akhila |
Gsl dental college and hospital |
Room number -10 ,Department of Periodontics ,GSL dental college ,Rajahmundry ,Andhra
pradesh ,533296,India
East Godavari
ANDHRA PRADESH |
7032914895
insakhila2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSL DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gingivitis group |
Gingival crevicular blood glucose and finger prick blood glucose levels will be obtained from the gingivitis group |
| Intervention |
Periodontitis group |
Gingival crevicular blood glucose and finger prick blood glucose levels will be obtained from the periodontitis group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are not under any medication |
|
| ExclusionCriteria |
| Details |
Patients with abnormally low or high hematocrits, as well as those with severe cardiovascular, hepatic, immunologic, renal, hematological, or other organ disorders, patients who required antibiotic premedication or who took coagulation-interfering medications, such as heparin, non-steroidal anti-inflammatory drugs, or coumarin derivatives were excluded.patients with known diabetes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the amount of blood glucose in gingival crevicular blood (GCBG) and finger prick blood (FPBG) and evaluate the difference between them in patients with gingivitis and periodontitis.
|
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To calculate PISA and PESA values and assess their relation with GCBG and FPBG in patients with gingivitis and periodontitis.
|
baseline |
To find out whether GCB can be used as a non-invasive, chairside tool to measure blood sugar levels.
|
baseline |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/10/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
A cross-sectional observational study will be conducted .The aim is to evaluate whether gingival crevicular blood (GCB), collected during routine periodontal probing, can serve as a reliable, minimally invasive alternative to finger-prick blood glucose (FPBG) testing. A total of 24 systemically healthy, non-diabetic patients aged above 18 years with at least 20 teeth will be recruited and divided into two groups—gingivitis and periodontitis. Blood glucose levels will be assessed from both GCB and FPBG using a glucometer, while periodontal parameters including probing pocket depth, clinical attachment level, and bleeding on probing will be recorded to calculate Periodontal Inflamed Surface Area (PISA) and Periodontal Epithelial Surface Area (PESA). The study seeks to compare and correlate GCB and FPBG values with PISA and PESA to determine the impact of periodontal inflammation on glucose levels. Findings are expected to validate the use of GCB as a convenient, non-invasive chairside tool for opportunistic diabetes screening in dental practice while highlighting the systemic implications of periodontal disease |