| CTRI Number |
CTRI/2022/09/045866 [Registered on: 26/09/2022] Trial Registered Prospectively |
| Last Modified On: |
21/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Novel Coriander mouthwash for treating gingivitis |
|
Scientific Title of Study
|
Efficacy of CORIANDRUM.SATIVUM Mouthwash in treatment of GINGIVITIS: A Microbilogical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GAGANASHREE S |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE & HOSPITAL |
| Address |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL ROOM NO 4,Department of PERIODONTOLOGY
#14 Ramohalli Cross , Kumbalagodu,Mysore road, Bangalore-560074
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL ROOM NO 4,Department of PERIODONTOLOGY
#14 Ramohalli Cross , Kumbalagodu,Mysore road, Bangalore-560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9482986805 |
| Fax |
|
| Email |
gaganashree2231@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S SAVITA |
| Designation |
PROFESSOR, HEAD OF THE DEPARTMENT |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE & HOSPITAL |
| Address |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL ROOM NO 4,Department of PERIODONTOLOGY
#14 Ramohalli Cross , Kumbalagodu,Mysore road, Bangalore-560074
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL ROOM NO 4,Department of PERIODONTOLOGY
#14 Ramohalli Cross , Kumbalagodu,Mysore road, Bangalore-560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9845446437 |
| Fax |
|
| Email |
dr.s.savita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GAGANASHREE S |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE & HOSPITAL |
| Address |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL ROOM NO 4,Department of PERIODONTOLOGY
#14 Ramohalli Cross , Kumbalagodu,Mysore road, Bangalore-560074
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL ROOM NO 4,Department of PERIODONTOLOGY
#14 Ramohalli Cross , Kumbalagodu,Mysore road, Bangalore-560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9482986805 |
| Fax |
|
| Email |
gaganashree2231@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr GAGANASHREE S |
| Address |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL ROOM NO 4, #14 RAMOHALLI CROSS , KUMBALAGODU,MYSORE ROAD, BANGALORE-560074 |
| 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 GAGANASHREE S |
RAJARAJESWARI DENTAL COLLEGE and HOSPITAL |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL ROOM NO 4,Department of PERIODONTOLOGY
#14 Ramohalli Cross , Kumbalagodu,Mysore road, Bangalore-560074
Bangalore
KARNATAKA |
9482986805
gaganashree2231@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE OF RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Novel CORIANDER MOUTHWASH |
coriander mouthwash given after scaling for group 2 |
| Comparator Agent |
only scaling |
for group 1 patients only scaling is done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
-patients aged between 18-35yrs.
-Clinically diagnosed for chronic generalised gingivitis.
|
|
| ExclusionCriteria |
| Details |
-Patients history of allergy to herbal medications.
-Patients with presence of periodontal pockets.
-Patients who have undergone periodontal treatment within a period of one year.Â
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| quantitative microbiological analysis |
baseline, 2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-gingival index
-gingival bleeding index |
baseline, 2weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/09/2022 |
| Date of Study Completion (India) |
21/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/03/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS IS A STUDY TO EVALUATE EFFICACY OF CORIANDRUM. SATIVUM MOUTHWASH IN TREATMENT OF GINGIVITIS : A MICROBIOLOGICAL STUDY. TOTAL OF 30 PATIENTS ARE INCLUDED IN STUDY 15 IN EACH GROUP. FIRST GROUP WILL UNDERGO ONLY SCALING SECOND GROUP WILL UNDERGO SCALING WITH CORIANDER MOUTHWASH FOR 2 WEEKS. SUBGINGIVAL PLAQUE SAMPLES ARE COLLECTED FOR MICROBIOLOGICAL ANALYSIS AND GINGIVAL INDEX AND GINGIVAL BLEEDING INDEX ARE RECORDED AT BASELINE AND 2 WEEKS . |