| CTRI Number |
CTRI/2025/04/084440 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Galectin-3 and TNF-Alpha Levels in Gingival Crevicular Fluid of Periodontitis Patients With and Without Obesity: An Observational Study |
|
Scientific Title of Study
|
Estimation of galectin-3 and tumor necrosis factor a levels in gingival crevicular fluid of periodontitis patients with and without obesity - An observational 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 |
Dr Divya Shonima |
| Designation |
Post Graduate 2nd year MDS |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Room no-3 , Department of Periodontology , 2nd floor ,
The Oxford Dental College , Bommanahalli ,
Bangalore - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
6305991495 |
| Fax |
|
| Email |
24divyashonima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savitha AN |
| Designation |
Professor, Department of Periodontology |
| Affiliation |
The Oxford Dental College , Bangalore |
| Address |
Room no-3 , Department of Periodontology , 2nd floor ,
The Oxford Dental College , Bommanahalli , Bangalore - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
6305991495 |
| Fax |
|
| Email |
sunaina1096@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Shonima |
| Designation |
Post Graduate 2nd year MDS |
| Affiliation |
The Oxford Dental College , Bangalore |
| Address |
Room no - 905 , B Block , Oxford girls hostel , The Oxford Dental College , Bommanahalli , Bangalore - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
6305991495 |
| Fax |
|
| Email |
24divyashonima@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College and Hospital, Bommanahalli, Bangalore, Karnataka - 560068 |
|
|
Primary Sponsor
|
| Name |
Dr Divya Shonima |
| Address |
Room no-905 , B block, Oxford girls hostel,
The Oxford Dental College, Bommanahalli, Bangalore - 560068 |
| 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 Divya Shonima |
The Oxford Dental College |
Room no-3 , Department of Periodontology , 2nd floor ,
The Oxford Dental College , Bommanahalli , Bangalore - 560068
Bangalore
KARNATAKA |
06305991495
24divyashonima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects of either sex, between the age of 20 and 60 years
2) Presence of at least 20 natural teeth
3) Individuals with healthy periodontium of clinical parameters of bleeding on probing less than 10 % and probing depth less than or equal to 3 mm
4) Patients with diagnosis of generalised stage III grade B periodontitis with clinical parameters of probing depth more than or equal to 6 mm and clinical attachment loss more than or equal to 5 mm
5) Subjects with obesity having BMI values given by Asia Pacific Perspective Obesity - WHO 2000
Non obese - between range of 18.5 to 22.9 kg/m2
Obese - between range of 25 to 29.9 kg/m2 |
|
| ExclusionCriteria |
| Details |
1) Individuals with systemic diseases
2) Smokers
3) Pregnant/lactating and postmenopausal women
4) Individuals who have received periodontal therapy in the last 6 months
5) Individuals who have history of antimicrobial and anti-inflammatory therapy in the past 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Galectin 3 and TNF alpha level in GCF |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical parameters - Gingival index, Bleeding on probing, Probing depth, Clinical attachment loss |
baseline |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
21/04/2025 |
| 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
|
This study is an observational study assesing the levels of Galectin-3 and Tumor necrosis factor alpha in GCF of periodontitis patients with and without obesity . It will be conducted in The Oxford Dental College , Bangalore in India . The primary outcome measure will be Galectin-3 and TNF alpha levels in GCF . The secondary outcome measure will be clinical parameters - Gingival index, bleeding on probing, probing depth and clinical attachment loss . 36 GCF sample is taken from 12 subjects in each group and biomarker levels will be assessed using ELISA method . |