| CTRI Number |
CTRI/2019/11/022041 [Registered on: 18/11/2019] Trial Registered Prospectively |
| Last Modified On: |
14/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of chlorhexidine and tree tea oil mouth rinse on oral halitosis |
|
Scientific Title of Study
|
“A natural alternative for antimicrobial activity on Solobacterium Moorei, a gram positive anaerobic pathogen associated with halitosis- a double blind randomized control study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSrikumar Prabhu |
| Designation |
Reader |
| Affiliation |
BIDS bangalore |
| Address |
Bangalore institute of dental sciences and post graduate research center. department of periodontics room number 5
Bangalore
KARNATAKA
560027
India |
| Phone |
|
| Fax |
|
| Email |
dr_ksrikumar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSriangarajan |
| Designation |
Professor and head |
| Affiliation |
BIDS bangalore |
| Address |
Bangalore institute of dental sciences and post graduate research center, department of periodontics ; room number5
Bangalore
KARNATAKA
560027
India |
| Phone |
|
| Fax |
|
| Email |
docranga@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBhagyashree |
| Designation |
Postgraduate student |
| Affiliation |
BIDS bangalore |
| Address |
Department of Periodontics, Room number 5
Bangalore institute of dental sciences and post graduate research center
Bangalore
KARNATAKA
560027
India |
| Phone |
|
| Fax |
|
| Email |
drbhagya1185@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Srikumar Prabhu, readerdepartment of perioodntics, room number 5 bangalore institute of dental science and postgraduate research center |
|
|
Primary Sponsor
|
| Name |
Dr Srikumar Prabhu |
| Address |
reader, Bangalore institute of dental sciences |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bhagyashree |
post graduate student, bangalore institute of |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srikumar Pabhu |
bangalore instittute of dental sciences |
department of perioodntics , romm number 5
5/3 hosur road next to nimhans convention center
Bangalore
KARNATAKA |
9845009397
dr_ksrikumar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| bangalore institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
oral halitosis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine
0.2% 10 ml twice daily
TreeTea oil
10 ml twice daily |
Halitosis and Non halitosis groups,10 ml Chlorhexidine mouth rinse and 10 ml Tree Tea oil mouth rinse twice daily for one week and placebo rinse for one week |
| Intervention |
tree tea oil mouth rinse |
10 ml tree tea oil mouth rinse twice daily for one week |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
genuine halitosis of oral origin, with full mouth organoleptic score of greater than 3 on Rosenberg’s scale (0-5) and VSC of greater than 157ppb., and probing pocket depth not exceeding 4 mm in any of the surfaces examined |
|
| ExclusionCriteria |
| Details |
smokers, individuals with systemic conditions or diseases, history of periodontal surgical therapy, and systemic medication related to oral dryness or history of systemic antibiotic therapy one month prior to commencement of the study, female patients on menstruation and pregnancy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| % Reduction in Solobacterium moorei Counts |
0 and 1 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in VSC scores |
0 and 1 Week |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
19/11/2019 |
| 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="0"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randamized,double blinded, placebo controlled clinical trial comparing the effect of naturally derived mouth rinse and chlorhexidine mouth rinse on reduction in oral halitosis scores. This study wil be carried out in a single center. The primary outcome measure is reduction in Solobacterium moorei counts and secondary outcome measurement will be reduction in halitosis score. The total duration of the study is one week. |