| CTRI Number |
CTRI/2025/07/090063 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of cell damage in people with gum disease and diabetes |
|
Scientific Title of Study
|
Assessment of cytogenic damage in chronic periodontitis and type 2 diabetes mellitus subjects through micronucleus test |
| 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 V Vasanth Ayswarya |
| Designation |
Reader |
| Affiliation |
Priyadarshini Dental College & Hospital |
| Address |
Department of Periodontics and Implantology, Room no.3, Ground floor, Priyadarshini dental college and hospital, No.1, VGR Gardens,VGR Nagar, Pandur, Thiruvallur
Thiruvallur
TAMIL NADU
631203
India |
| Phone |
9361910124 |
| Fax |
|
| Email |
vvayswarya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Vasanth Ayswarya |
| Designation |
Reader |
| Affiliation |
Priyadarshini Dental College & Hospital |
| Address |
Department of Periodontics and Implantology, Room no.3, Ground floor, Priyadarshini dental college and hospital, No.1, VGR Gardens,VGR Nagar, Pandur, Thiruvallur
Thiruvallur
TAMIL NADU
631203
India |
| Phone |
9361910124 |
| Fax |
|
| Email |
vvayswarya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Vasanth Ayswarya |
| Designation |
Reader |
| Affiliation |
Priyadarshini Dental College & Hospital |
| Address |
Department of Periodontics and Implantology, Room no.3, Ground floor, Priyadarshini dental college and hospital, No.1, VGR Gardens,VGR Nagar, Pandur, Thiruvallur
TAMIL NADU
631203
India |
| Phone |
9361910124 |
| Fax |
|
| Email |
vvayswarya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Priyadarshini dental college and hospital, No.1, VGR Gardens, VGR Nagar, Pandur, Thiruvallur - 631203 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911 ยท Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 V Vasanth Ayswarya |
Priyadharshini Dental College and Hospital |
Department of Periodontics and Implantology, Room no.3, Ground floor, Priyadarshini dental college and hospital, No.1, VGR Gardens,VGR Nagar, Pandur, Thiruvallur
Thiruvallur
TAMIL NADU |
09361910124
vvayswarya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee - PDCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic periodontitis and Type 2 diabetes mellitus |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. The subject should have at least 7 or more teeth.
2. The subjects with Deep periodontal pockets greater than or equal to 6 mm in 2 non adjacent sites (or) Clinical attachment loss (CAL) greater than or equal to 4 mm in at least 4 non adjacent teeth are included for chronic periodontitis.
3. Patients with Hb A1C greater than 8 are included for diabetes.
Group A- healthy subjects with no periodontitis or systemic disease
Group B- chronic periodontitis with no systemic disease
Group C - diabetes without chronic periodontitis
Group D - chronic periodontitis and diabetes
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of periodontal therapy prior to 6 months.
2. Subjects under intake of drugs such as NSAIDS, Corticosteroids, antibiotics, cytotoxic agents.
3. Subjects with systemic illness, oral lesions.
4. Subjects with any history of malignancies or radiation.
5. Subjects having viral infection or pyrexia for over past one month.
6. History of smoking or alcohol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate cytogenic damage to gingival cells in chronic periodontitis subjects and its association with diabetes. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2026 |
| 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="2"
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 case-control study investigates the cytogenetic damage in the gingival cells of individuals with chronic periodontitis and its association with diabetes mellitus. Periodontitis, an inflammatory disease triggered by plaque biofilm, and diabetes, a metabolic disorder, share a bi-directional relationship that exacerbates both conditions. The study highlights the role of oxidative stress, reactive oxygen species (ROS), and advanced glycation end products (AGEs) in promoting inflammation, DNA damage, and tissue destruction in both diseases. Given the shared mechanisms of oxidative DNA damage and increased genotoxic stress, this study aims to evaluate the extent of cytogenetic alterations in gingival tissues, particularly in diabetic individuals with chronic periodontitis, by assessment of micronucleated and binucleated cells through the micronucleus test, to better understand the underlying pathogenic link between these two chronic conditions. |