| CTRI Number |
CTRI/2024/05/067603 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison study of Green tea extract gel and Curcumin nanoparticle gel in gum disease patients along with cleaning |
|
Scientific Title of Study
|
Comparative evaluation of clinical efficacy and total antioxidant capacity of curcumin nanoparticle gel and green tea extract gel as an adjunct to scaling & root planing and scaling and root planing alone in treatment of stage 2 periodontitis patients A split mouth 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 Dikson Kuriakose |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences Department of Periodontics and
Implantology Room no 4 Kanjithanda Kushalappa campus Maggula
Virajpete Kodagu Karnataka 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
7736977565 |
| Fax |
|
| Email |
kuriakosedikson@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dikson Kuriakose |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences Department of Periodontics and
Implantology Room no 4 Kanjithanda Kushalappa campus Maggula
Virajpete Kodagu Karnataka 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
7736977565 |
| Fax |
|
| Email |
kuriakosedikson@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika B |
| Designation |
Professor |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences Department of Periodontics and
Implantology Room no 4 Kanjithanda Kushalappa campus Maggula
Virajpete Kodagu Karnataka 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
9742096982 |
| Fax |
|
| Email |
radika_b24@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Coorg Institute of Dental Sciences, Department of Periodontics and Implantology, Kanjithanda
Kushalappa Campus, Maggula, Virajpet-571218, Kodagu, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Dikson Kuriakose |
| Address |
Coorg Institute of Dental Sciences Department of Periodontics and
Implantology Room no 4 Kanjithanda Kushalappa campus Maggula
Virajpete Kodagu Karnataka 571218 |
| 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 Dikson Kuriakose |
Coorg Institute of Dental Sciences |
Department of Periodontics and
Implantology Room no 4 Kanjithanda Kushalappa campus Maggula
Virajpete Kodagu Karnataka 571218
Kodagu
KARNATAKA |
7736977565
kuriakosedikson@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION REVIEW BORD, COORG INSTITUTE OF DENTAL SCIENCE |
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 |
| Intervention |
Curcumin nanoparticle gel |
Curcumin nanoparticle gel will be applied directly into the pocket until it overflows from the pocket at baseline following scaling and root planing |
| Intervention |
Green tea extract gel |
Green tea extract gel will be applied directly into the pocket until it overflows from the pocket at baseline following scaling and root planing |
| Comparator Agent |
Scaling and root planing |
After sample collection scaling
and root planing to be done at
baseline following initial
examination |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are diagnosed with clinical stage 2 periodontitis, with probing depth greater than or equal to 5mm in at least 3 quadrants, and willing for treatment. Patients with age range of 25-55 years are included in the study and comprises of both sexes. Minimum of 15 teeth should be remaining |
|
| ExclusionCriteria |
| Details |
Systemically compromised patients.
Use of antibiotics in the past 6 months
Steroid or inflammatory drugs for 7 days in 3 months
Known allergy to the above-mentioned drugs/substance
Smokers and alcoholic
Pregnant and lactating women
Periodontal therapy within 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of curcumin nanoparticle gel and green tea extract as an adjunct to scaling and root planing on clinical parameters and total antioxidant capacity in GCF of patient with Stage 2 periodontitis. |
All clinical parameters will be measured and
GCF sample collection will be done at baseline, 1 month and 3 months after the therapy. Gel application will be done at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of curcumin nanoparticle gel and green tea extract gel as an
adjunct to scaling root planing and scaling and root planing alone on clinical
parameters and antioxidant capacity in GCF of patient with Stage 2 periodontitis. |
All clinical parameters will be measured and
GCF sample collection will be done at baseline, 1 month and 3 months after the therapy. Gel application will be done at baseline |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
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 2 |
|
Date of First Enrollment (India)
|
05/06/2024 |
| 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
|
This study is designed to be a split mouth study where 17 patients of both the gender with Stage 2 periodontitis, satisfying all the inclusion criteria will be enrolled for the study. The total sample size calculated is 51 sites, further randomly divided into 3 groups of 17 sites per group and is treated by scaling and root planing, scaling and root planing with green tea extract gel and scaling and root planing with curcumin nanoparticle gel application. All clinical parameters will be measured and GCF collection will be done at baseline, 1 month, 3 months after scaling and root planing and gel application .The purpose of the study will be explained to every selected patients and his or her written consent will be obtained prior to the commencement of the study. The demographic characteristics of the patients (age & sex), Probing pocket depth (PPD), clinical attachment level (CAL), Plaque index (PI), Gingival Index (GI), Bleeding on probing (BOP) will be recorded before the commencement of procedures. Hence the present study, attempts evaluate the clinical efficacy and total antioxidant capacity of curcumin nanoparticle gel and green tea extract gel as an adjunct to scaling and root planing in treatment of Stage 2 periodontitis |