| CTRI Number |
CTRI/2025/02/080183 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Application and comparison of two medicinal gels in patients with gum disease after cleaning of teeth and assessing interleukin 1 beta marker before and after cleaning of teeth- a randomised controlled trial |
|
Scientific Title of Study
|
A COMPARISON OF EFFICACY OF SUB-GINGIVAL DELIVERY OF NANOPARTICLE PROPOLIS GEL AND NANOCATECHIN GEL AS ADJUNCTS TO NON SURGICAL PERIODONTAL THERAPY ON INTERLEUKIN 1-BETA LEVELS IN CHRONIC PERIODONTITIS PATIENTS-A CLINICAL AND IMMUNOLOGICAL ASSAY
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GHIMA BINDU |
| Designation |
READER |
| Affiliation |
Panineeya Mahavidyalaya institute of dental sciences and research centre |
| Address |
Room no 101, Department of periodontics, Panineeya Mahavidyalaya institute of Dental Sciences and Research Centre, road no 5, Kamalanagar, dilsukhnagar, hyderabad, Telangana
Hyderabad
TELANGANA
500060
India |
| Phone |
09959200225 |
| Fax |
|
| Email |
bindurakasi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GHIMA BINDU |
| Designation |
READER |
| Affiliation |
Panineeya Mahavidyalaya institute of dental sciences and research centre |
| Address |
Room no 101, Department of periodontics, Panineeya Mahavidyalaya institute of Dental Sciences and Research Centre, road no 5, Kamalanagar, dilsukhnagar, hyderabad, Telangana
TELANGANA
500060
India |
| Phone |
09959200225 |
| Fax |
|
| Email |
bindurakasi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RING GAHANA |
| Designation |
POST GRADUATE |
| Affiliation |
Panineeya Mahavidyalaya institute of dental sciences and research centre |
| Address |
Room no 101, Department of periodontics, Panineeya Mahavidyalaya institute of Dental Sciences and Research Centre, road no 5, Kamalanagar, dilsukhnagar, hyderabad, Telangana
Hyderabad
TELANGANA
500060
India |
| Phone |
9959441453 |
| Fax |
|
| Email |
gahana.ring@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panineeya Mahavidyalaya Institute of Dental Sciences and Research centre, road no 5, Kamalanagar, Dilsukhnagar, Hyderabad. |
|
|
Primary Sponsor
|
| Name |
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre |
| Address |
road no 5 , Kamalanagar, Dilsukhnagar, Hyderabad. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| RING GAHANA |
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre |
Room no 101, Department of periodontics, Panineeya Mahavidyalaya institute of Dental Sciences and Research Centre, road no 5, Kamalanagar, dilsukhnagar, hyderabad, Telangana
Hyderabad
TELANGANA |
9959441453
gahana.ring@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group I (14): Scaling and Root Planing (SRP) with application of placebo (hydroxyethylcellulose) gel. |
Baseline, 6 weeks and at 3 months |
| Intervention |
Group II (14): SRP along with application of nanoparticle propolis gel.
|
Baseline, 6 weeks and at 3 months |
| Intervention |
Group III (14): SRP along with application of nanocatechin gel. |
Baseline, 6 weeks and at 3 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 25 to 55 years.
Probing Pocket Depth PPD greater than 5mm. Patients who have not received periodontal therapy, within preceding 6 months of the study
|
|
| ExclusionCriteria |
| Details |
Patients who were on antibiotics/anti inflammatory drugs in the last 3 months.
Pregnant and lactating females.
Medically compromised patients.
Smokers, tobacco chewers and alcoholics.
Patients who are allergic to drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical improvement with both the gels.
Which gel is superior to the other?
|
Baseline 6 weeks 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical improvement with both the gels.
Which gel is superior to the other?
|
Baseline 6 weeks 3 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 4 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="3"
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
|
Periodontal pockets present an ideal site for treatment using localized drug delivery systems. Within the field of periodontics, there are established approaches for delivering drugs directly to subgingival sites or periodontal pockets. There are a range of local drug delivery systems including fibers, gels, strips, films, irrigating systems, microparticles and nanoparticles. | LOCAL DRUG DELIVERY Local drug delivery system is the application of anti- microbial or anti-infective agent that would target pathogenic microorganisms by delivering it at the base of the pocket yielding a stable and good clinical outcome along with mechanical debridement. PROPOLIS Propolis is a natural, non-toxic, resinous, yellow–brown to dark brown substance collected through honey bees from trees, and other plant sources. Due to its beneficial properties like antimicrobial, anticancer, antifungal, antiviral, and anti-inflammatory effects, Propolis has been used extensively for for the management of periodontal pocket in patients with periodontitis in various forms such as paste, tablet, ointment, oil, mouthwash, etc. CATECHIN Catechin is the active substance of the green tea plant known for its very useful and prominent biological functions such as antimicrobial, anti-cancer, antioxidant, and anti-inflammatory activity. Its strong antimicrobial effects reduces gingival inflammation. | INTERLEUKIN beta 1 A pro-inflammatory-cytokine, that participates in immune regulation and bone resorption in periodontitis. It is mainly expressed in gingival fibroblasts, periodontal ligament cells, and osteoblasts. IL-1beta increases the expression of collagenolytic enzymes, matrix metalloproteinases MMPs, which contribute to extracellular matrix degradation and in turn lead to bone resorption and tissue destruction, an important indicator of the severity and progression of periodontitis. |