| CTRI Number |
CTRI/2021/10/037549 [Registered on: 25/10/2021] Trial Registered Prospectively |
| Last Modified On: |
21/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison between lemongrass oil and chlorohexidine mouth wash effectiveness in bacterial control before before treatment of gums |
|
Scientific Title of Study
|
A comparative evaluation of antimicrobial activity of lemon grass oil and chlorhexidine as a preprocedural mouth rinse. A clinical 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 Vinnakota Keerthi |
| Designation |
senior lecturer MDS in Periodontics |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Periodontics and Implantology
Vishnu Dental College
Bhimavaram
Andhra Pradesh 534202
Department of Periodontics and Implantology
Vishnu Dental College
Bhimavaram
Andhra Pradesh 534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9030384841 |
| Fax |
|
| Email |
keerthi.vinnakota@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishnam Raga Pavitra |
| Designation |
BDS Student |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Periodontics and Implantology
Vishnu Dental College
Bhimavaram
Andhra Pradesh 534202
Department of Periodontics and Implantology
Vishnu Dental College
Bhimavaram
Andhra Pradesh 534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9030543800 |
| Fax |
|
| Email |
ragapavitra1331@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVinnakota Keerthi |
| Designation |
senior lecturer MDS in Periodontics |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Periodontics and Implantology
Vishnu Dental College
Bhimavaram
Andhra Pradesh 534202
Department of Periodontics and Implantology
Vishnu Dental College
Bhimavaram
Andhra Pradesh 534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9030384841 |
| Fax |
|
| Email |
keerthi.vinnakota@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Krishnam Raga Pavitra |
| Address |
Block2 room no7 Department of periodontics and implantology |
| 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 |
| Krishnam Raga Pavitra |
Krishnam Raga Pavitra |
room no 7, block -2,
department of
periodontics and
implantology, vishnu
dental college
vishnupur bhimavaram
pin:534202
West Godavari
ANDHRA PRADESH
West Godavari
ANDHRA PRADESH |
9030543800
ragapavitra1331@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine mouthwash |
Preprocedural mouth rinse
dose 10ml
frequency once
duration of therapy 5min |
| Intervention |
lemongrass oil |
Preprocedural mouthrinse
dose 10ml
frequency once
duration of therapy 5min |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age range of 20-50 years
Minimum of 20 teeth in the mouth
Patients have not received any periodontal treatment in the last 3 months
|
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled systemic diseases.
Physically and Mentally Challenged individuals
|
|
|
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 |
| microbial growth |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
31/10/2021 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|