| CTRI Number |
CTRI/2026/03/105541 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking whether certain genetic variations are linked to gum disease in people from South India |
|
Scientific Title of Study
|
Evaluation of the association of OGG1 and APE1 gene polymorphisms in patients with periodontitis in the South Indian population. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Helen Reshma K |
| Designation |
PG student |
| Affiliation |
SRM Dental College |
| Address |
SRM Dental College
Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9360715721 |
| Fax |
|
| Email |
reshmahelen752000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeetha S |
| Designation |
Professor |
| Affiliation |
SRM Dental college |
| Address |
SRM Dental College
Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9884563217 |
| Fax |
|
| Email |
sangeetha_doc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeetha S |
| Designation |
Professor |
| Affiliation |
SRM Dental college |
| Address |
SRM Dental College
Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9884563217 |
| Fax |
|
| Email |
sangeetha_doc@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Helen Reshma K |
| Address |
SRM Dental College
Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089 |
| 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 Sangeetha S |
SRM Dental College |
4th floor, Dept of Periodontology, SRM Dental College, Bharathi salai, Ramapuram, Chennai 600089
Chennai
TAMIL NADU |
9884563217
sangeetha_doc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee and Review Board SRM Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically and periodontally healthy subjects with no clinical attachment loss |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients of age 30 to 60 are to be recruited for the study.
2. Ethnic South Indian subjects.
3. Control group to include subjects with no signs of periodontal disease and probing sulcus depth less than 3mm with no evidence of clinical attachment loss.
4. Test group to include patients with Probing Pocket Depth greater than 6mm and or Clinical Attachment Loss greater than 5mm in greater than 30 percentage of sites with periodontitis. (Stage II/III Periodontitis)
|
|
| ExclusionCriteria |
| Details |
1. Patients with any other inflammatory systemic conditions such as diabetes mellitus, rheumatoid arthritis, etc.
2. Patients with immunodeficiency disorders.
3. Patients with local modifiers like food impaction, factitious habits and bruxism.
4. Patients who smoke.
5. Use of orthodontic and prosthetic appliances.
6.Patients who had taken systemic antibiotic, anti-inflammatory, hormonal or other assisted drug therapy in the last 6 months or prior to the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the association of OGG1 and APE1 gene polymorphisms in the study group participants.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the association of OGG1 and APE1 gene polymorphisms between the control and test groups.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
31/03/2026 |
| 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="1"
Months="0"
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
|
To evaluate and compare the association of OGG1 and APE1 gene polymorphisms in patients with and without periodontitis in the South Indian population.
|