| CTRI Number |
CTRI/2025/04/085323 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
relationship of hunger hormone in gum fluid and blood in patients with dental infection |
|
Scientific Title of Study
|
Evaluation of Human Ghrelin Levels in Patients with Chronic Periodontitis before and after Non-Surgical periodontal therapy : An Experimental Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Gupta |
| Designation |
Postgraduate student |
| Affiliation |
Institute of dental sciences |
| Address |
Room no 228 Department of periodontolgy and implantolgy Institute of dental sciences pilibhit bypass road bareilly
Bareilly
UTTAR PRADESH
243001
India |
| Phone |
7985950296 |
| Fax |
|
| Email |
shivanigupta2941@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prerna agarwal |
| Designation |
Professor Department of Periodontology & Implantology, |
| Affiliation |
Institute of dental sciences |
| Address |
Room no 228 Department of periodontolgy and implantolgy Institute of dental sciences pilibhit bypass road bareilly
Bareilly
UTTAR PRADESH
243001
India |
| Phone |
9927900055 |
| Fax |
|
| Email |
journalprerna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna agarwal |
| Designation |
Professor Department of Periodontology & Implantology, |
| Affiliation |
Institute of dental sciences |
| Address |
Room no 228 Department of periodontolgy and implantolgy Institute of dental sciences pilibhit bypass road bareilly
UTTAR PRADESH
243001
India |
| Phone |
9927900055 |
| Fax |
|
| Email |
journalprerna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of dental sciences pilibhit bypass road opposite to suresh sharma nagar, chandpur bichpuri, Bareilly Uttar Pradesh 243006 India |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Sciences |
| Address |
Institute of dental sciences pilibhit bypass road opposite to suresh sharma nagar, chandpur bichpuri, Bareilly Uttar Pradesh 243006 India |
| Type of Sponsor |
Other [Private dental collage] |
|
|
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 Prerna agarwal |
Institute of dental sciences |
Room no 228 department of periodontology and implantology Institute of dental sciences pilibhit bypass road opposite to suresh sharma nagar, chandpur bichpuri, Bareilly Uttar Pradesh 243006 India
Bareilly
UTTAR PRADESH |
9927900055
journalprerna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Institute of dental sciences, Bareilly, U.P. |
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: K053||Chronic periodontitis, (3) ICD-10 Condition: M272||Inflammatory conditions of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ghrelin |
Ghrelin was initially described as a natural peptide hormone which is predominantly
a product of the stomach gastric enteroendocrine XA cells as well as the kidneys and
brain pituitary gland hypothalamus and hippocampus |
| Intervention |
Non surgical periodontal therapy |
Scaling and root planing
6 months duration |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ï‚·The individuals between the age of 20-60 years and having at least 15 functional teeth.
ï‚· Chronic periodontitis patients having at least 30 sites that bleed on probing.
ï‚· Patients of CP should have periodontal pocket depth at least 5mm and clinical attachment level (CAL) at least 4mm. |
|
| ExclusionCriteria |
| Details |
ï‚·Individuals with any type of systemic ailment.
ï‚· Pregnant or lactating patients.
ï‚·Patients who have been taking alcohol or smoking tobacco.
ï‚·The patients who received periodontal care within the last six months or who were prescribed antibiotics and analgesics during that time.
ï‚·Patients who are taking medications for long term especially those effecting gastric secretions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of non surgical periodontal therapy on Ghrelin levels |
0 days 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Literature reveal genuine data about reducing levels of ghrelin in GCF is a
site specific inflammatory condition for example periodontitis Hence this observational
study will be done to analyze the quantity of ghrelin in the serum and GCF in patients of
chronic periodontitis before and after scaling |
6 months 0 day |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| 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="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
|
Ghrelin down- regulates the lipopolysaccharide (LPS) induced pro-inflammatory cytokines production (including interleukin IL-6, IL-1β and tumor necrosis factor (TNF- alpha) and exhibits strong anti-inflammatory activity. In addition to anti-inflammatory activity, ghrelin also stimulates the differentiation and proliferation of osteoblastic cells and enhances bone formation. Further, serum gives information about periodontal pathogen-induced inflammation and reaction. Literature reveal genuine data about reducing levels of ghrelin in GCF is a site-specific inflammatory condition, for example periodontitis. Hence, this observational study will be done to analyze the quantity of ghrelin in the serum and GCF in patients of chronic periodontitis (CP) before and after scaling. |