| CTRI Number |
CTRI/2024/05/067602 [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
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison study of Green coffee bean extract gel and Chlorhexidine gel in gum disease patients along with cleaning |
|
Scientific Title of Study
|
TO COMPARE AND ASSESS THE CLINICAL PARAMETER AND ANTIMICROBIAL EFFICACY OF SCALING & ROOT PLANING ALONE AND CHLORHEXIDINE GEL AND GREEN COFFEE BEAN EXTRACT GEL AS ADJUNCT TO SCALING & ROOT PLANING AGAINST P.GINIGIVALIS IN STAGE 2 PERIODONTITIS PATIENTS A 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 |
Anisha Korikani |
| Designation |
Post graduate student |
| Affiliation |
|
| Address |
Coorg institute of dental sciences ,Department of periodontics and
implantology, Room 4, Kanjithanda Kushalapa campus, Maggula, Virajpete, Kodagu,Karnataka
Kodagu
KARNATAKA
571218
India |
| Phone |
9440153597 |
| Fax |
|
| Email |
anishanarayan.83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anisha Korikani |
| Designation |
Post Graduate Student |
| Affiliation |
Coorg Institute of dental sciences |
| Address |
Coorg institute of dental sciences ,Department of periodontics and implantology, Room 4, Kanjithanda Kushalapa campus, Maggula, Virajpete, Kodagu,Karnataka
Kodagu
KARNATAKA
571218
India |
| Phone |
9440153597 |
| Fax |
|
| Email |
anishanarayan.83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Krishna Raj G N |
| Designation |
Professor |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Coorg institute of dental sciences ,Department of periodontics and implantology, Room 4, Kanjithanda Kushalapa campus, Maggula, Virajpete, Kodagu,Karnataka
Kodagu
KARNATAKA
571218
India |
| Phone |
7259456314 |
| Fax |
|
| Email |
dentalsolutions@gmail.com |
|
|
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. ANISHA KORIKANI |
| Address |
Coorg institute of Dental Sciences Department of Periodontics and Implantology Kanjithanda Kushalappa Campus Maggula Virajpet 571218 Kodagu Karnataka |
| Type of Sponsor |
Other [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 |
| Anisha Korikani |
coorg institute of dental sciences |
Department of
periodontics and
implantology ,Room no.4,
kanjithnda kushalappa
campus, Maggula, Virajpete,kodagu, Karnataka
Kodagu
KARNATAKA |
9440153597
anishanarayan.83@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 |
Chlorhexidine gel |
Chlorhexidine gel will be applied directly into the pocket until it overflows from the pocket once at baseline following intial examination |
| Intervention |
Green coffee bean extract 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 scaling
and root planing to be done once 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 |
Patients with systemic diseases such as diabetes mellitus, cardiovascular disorder, immunologic disorders, hepatitis and human immunodeficiency virus infections. Pregnant and lactating women and those taking oral contraceptive drugs. Subjects who had received antibiotics or treatment for periodontal disease in the 6 months. Steroid or inflammatory drugs for 7 days in 3 months. Known allergy to the above mentioned drugs/substance. Smokers and alcoholic
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Antimicrobial efficacy of green coffee bean extract gel and chlorhexidine gel as an adjunct to scaling & root planing against P.gingivalis in stage 2 periodontitis patients |
All clinical parameters will be measured and
Subgingival plaque sample collection will be done at baseline and 3 months after the therapy.
Gel application will be done at baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare clinical parameter and Antimicrobial efficacy between scaling & root planing group ,chlorhexidine gel and green coffee bean extract gel as an adjunct to scaling and root planing against P. gingivalis in stage 2 periodontitis patients |
All clinical parameters will be measured and
Subgingival plaque sample collection will be done at baseline and 3 months after the therapy.
Gel application will be done at baseline |
|
|
Target Sample Size
|
Total Sample Size="13"
Sample Size from India="13"
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 3 |
|
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 13 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 13 patients , further randomly divided in 3 groups/Quadrants with
39 sites in total. `The quadrant will be allocated using computerized
randomization method and is treated by scaling & root planing alone,
scaling & root planing with commercial available chlorhexidine gel and green coffee bean extract gel as an adjunct
to scaling & root planing.
The
assessment will be carried out as:
Group A- Scaling and root planning alone.
Group
B- Scaling and
root planing with chlorhexidine gel as
an adjunct.
Group C- Scaling and root planning with green coffee
bean extract gel as an adjunct.
Subgingival
plaque sample collection will be done at baseline and 3 months after the
therapy.
The demographic characteristics of the patients
(age & sex),Clinical parameters such as Probing pocket depth (PPD),
clinical attachment level (CAL), Plaque index (PI), Gingival Index (GI),
Bleeding on probing (BOP) will also be recorded at base line and at 3 months
after periodontal therapy |