| CTRI Number |
CTRI/2025/07/090127 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Estimation and Correlation of ghrelin and TNF-alpha levels in GCF of Healthy individuals and Chronic generalized periodontitis individuals with and without obesity |
|
Scientific Title of Study
|
Estimation and Correlation of ghrelin and TNF-alpha levels in GCF of Health and Chronic generalized periodontitis with and without obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M B Kaustubh Ram |
| Designation |
3rd year MDS |
| Affiliation |
The Oxford dental college , Bangalore |
| Address |
NO.943 SIRI next to weavers street school d knogadiyappa road Doddaballapur Bangalore rural 561203
Room No. 3 Department of periodontology , The Oxford dental college Bangalore
Bangalore Rural
KARNATAKA
561203
India |
| Phone |
9916557585 |
| Fax |
|
| Email |
kaustubhram007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kaustubh Ram |
| Designation |
3rd year MDS |
| Affiliation |
The Oxford dental college , Bangalore |
| Address |
The Oxford Dental college, Bommanahalli, Bangalore
Room No. 3 Department of periodontology , The Oxford dental college Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9845203336 |
| Fax |
|
| Email |
sunaina1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M B Kaustubh Ram |
| Designation |
3rd year MDS |
| Affiliation |
The Oxford dental college , Bangalore |
| Address |
NO.943 SIRI next to weavers street school d knogadiyappa road Doddaballapur Bangalore rural 561203
Room No. 3 Department of periodontology , The Oxford dental college Bangalore
Bangalore Rural
KARNATAKA
561203
India |
| Phone |
9916557585 |
| Fax |
|
| Email |
kaustubhram007@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental college, Bommanahalli,Bangalore,Karnataka,India,560068 |
|
|
Primary Sponsor
|
| Name |
Kaustubh Ram |
| Address |
No.943 SIRI next to weavers street school d knogadiyappa road Doddaballapur Bangalore rural , Karnataka , India , 561203 |
| Type of Sponsor |
Other [Self sponcer] |
|
|
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 |
| Kaustubh Ram |
The Oxford dental college. |
Room No. 3 Department of periodontology.
Bangalore
KARNATAKA |
9916557585
kaustubhram007@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: K051||Chronic gingivitis, (2) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.presence of at least 20 natural teeth
2.Individuals with healthy periodontium
3.Subjects with normal lipid profile having BMI values given by Asian pacific Obesity-WHO 2000
a. In non obese BMI - 18.5 to 22.9
b. In Obese BMI - 25 to 29.9 |
|
| ExclusionCriteria |
| Details |
1.Individuals who have received periodntal therapy in last 6 months
2.individuals with Systemic disease other than obesity
3.individuals who have history of antimicrobial and anti inflammatory therapy in the past last 6 months
4.pregnent and lactating mother
5.smokers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Levels of Ghrelin and THF-alpha in GCF in healthy, periodontitis with and without obesity |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival Index, Plaque Index , BMI |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/07/2025 |
| 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="2"
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 elevates the correlation between Ghrelin and TNF -alpha in 3 groups 1. healthy 2. periodontitis with out obesity 3. periodontitis with obesity. Ghrelin has immunomodulatory functions and it is modulated by Periodontal bacteria, leading to increased TNF-alpha expression and Inflammation in periodontal tissue , especially in obesity related periodontitis. the objective of this study is to explore the possibility of using Ghrelin as a inflammatory biomarker in Stage III grade B period0ntitis |