| CTRI Number |
CTRI/2024/03/064079 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Screening Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison study of Green coffee bean extract gel in gum disease patients along with cleaning |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF EFFECT OF SCALING AND ROOT PLANING ALONE AND GREEN COFFEE BEAN EXTRACT GEL AS AN ADJUNCT TO SCALING AND ROOT PLANING ON TOTAL ANTIOXIDANT CAPACITY IN PATIENTS WITH STAGE â…¡ PERIODONTITIS- CLINICO BIOCHEMICAL 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 |
LINET V GEORGE |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Coorg institute of dental science |
| Address |
Coorg institute of dental sciences
Department of periodontics and implantology
Room 4
K K campus
Maggula
Virajpet
Karnataka
Kodagu Coorg institute of dental sciences
Department of periodontics and implantology
Room 4
K K campus
Maggula
Virajpet
Karnataka
Kodagu Kodagu KARNATAKA 571218 India |
| Phone |
9945312604 |
| Fax |
|
| Email |
linetgeorge98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
LINET V GEORGE |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Coorg institute of dental sciences
Department of periodontics and implantology
Room 4
K K campus
Maggula
Virajpet
Karnataka
Kodagu Coorg institute of dental sciences
Department of periodontics and implantology
Room 4
K K campus
Maggula
Virajpet
Karnataka
Kodagu Kodagu KARNATAKA 571218 India |
| Phone |
9945312604 |
| Fax |
|
| Email |
linetgeorge98@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr JAYAPRAKASH G S |
| Designation |
Professor |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Coorg institute of dental sciences
Department of periodontics and implantology
Room 4
Kanjithnda Kushalappa campus
Maggula
Virajpet
Karnataka
Kodagu
Kodagu KARNATAKA 571218 India |
| Phone |
9972912662 |
| Fax |
|
| Email |
jayaprakashgadagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg institute of dental sciences
Department of periodontics and implantology
Room 4
Kanjithnda Kushalappa campus
Maggula
Virajpet
Karnataka
Kodagu |
|
|
Primary Sponsor
|
| Name |
LINET V GEORGE |
| Address |
Coorg institute of dental sciences
Department of periodontics and implantology
Room 4
Kanjithnda Kushalappa campus
Maggula
Virajpet
Karnataka
Kodagu |
| 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 |
| LINET V GEORGE |
Coorg institute of dental sciences |
Coorg institute of dental sciences
Department of periodontics and implantology
Room 4
Kanjithnda Kushalappa campus
Maggula
Virajpet
Karnataka
Kodagu Kodagu KARNATAKA |
9945312604
linetgeorge98@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
green coffee bean gel |
Green coffee bean extract gel will be applied directly into the pocket until it overflows from the pocket once at baseline following initial examination |
| Comparator Agent |
scaling and root planing |
After sample collection single
sitting full mouth scaling and root planing to be done once at baseline following initial examination |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are diagnosed with clinical Stage II periodontitis and willing for treatment.Patients 20 to 55 years of age.Patients with periodontal pocket depth greater than or equals to 5mm at least in 2 quadrants.Minimum of 15 teeth should be remaining.
|
|
| ExclusionCriteria |
| Details |
Systematically compramised patients.use of antibiotics in past 6 months. Steriods or inflammatory drugs for 7 days in 3 months. Known allergy to above mentioned drug or substances. 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 |
| Evaluate the Total antioxidant capacity efficacy of green coffee bean extract gel as an adjunct to Scaling and Root Planing in Stage II periodontitis patients |
All clinical parameters will be measured and GCF collection will be done at baseline, 1 month and 3 month after scaling and root planing and gel application will be done at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the results of clinical parameters & Total antioxidant capacity levels between scaling & root planing alone & green coffee bean extract gel as an adjunct to Scaling & root planing in the management of Stage II periodontitis |
All clinical parameters will be measured & GCF collection will be done at baseline, 1 month & 3 month after scaling & root planing & gel application will be done at baseline |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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)
|
25/06/2024 |
| 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
Modification(s)
|
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 single blinded randomized control trial where 15 patients of both the gender with Stage II periodontitis (accordance with the guidelines established during the World Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions - stage II) with probing pocket depth equal to or lesser than 5 mm in atleast 2 quadrant . The total sample size calculated is 15 patients. This will be a split mouth study where the oral cavity is divided into right and left quadrant. One quadrant will be treated by scaling and root planing alone, and counterpart quadrant with scaling and root planing with green coffee bean extract gel application. The quadrant will be selected using computerized randomization method. Thereby a total of 30 sites will be included in the study. All clinical parameters will be measured and GCF collection will be done at baseline, 1 month and 3 month after scaling and root planing and gel application will be done at baseline. Full mouth scaling and root planing and gel application will be performed at baseline following initial examination. Therefore, this study is an attempt to evaluate the total antioxidant capacity efficacy of green coffee bean etract gel as an adjunct to scaling and root planing in stage II periodontitis patients among patients attending outpatient department of Coorg institute of dental sciences ,Virajpet for treatment. |