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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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