| CTRI Number |
CTRI/2018/03/012651 [Registered on: 19/03/2018] Trial Registered Prospectively |
| Last Modified On: |
16/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of tulsi and chlorhexidine mouthwashes on saliva and tongue pH |
|
Scientific Title of Study
|
Comparison of effectiveness of chlorhexidine and tulsi mouth washes on oral pH: A Randomized Controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dukkireddy Divya |
| Designation |
Postgraduate Student |
| Affiliation |
Dayananda Sagar College of Dental Sciences |
| Address |
Department of Public Health Dentistry,
Room No-2
Dayananda Sagar College of Dental Sciences, Shavige Malleshwara hills, Kumarswamy Layout, Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
7259224735 |
| Fax |
|
| Email |
divya.dukkireddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha Kulkarni GUIDE |
| Designation |
Reader |
| Affiliation |
Dayananda Sagar College of Dental Sciences |
| Address |
Department of Public Health Dentistry,
Room No-2, Dayananda Sagar College of Dental Sciences, Shavige Malleshwara hills, Kumarswamy Layout, Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
9880577585 |
| Fax |
|
| Email |
drsmithabk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dukkireddy Divya |
| Designation |
Postgraduate Student |
| Affiliation |
Dayananda Sagar College of Dental Sciences |
| Address |
Department of Public Health Dentistry,
Room No-2, Dayananda Sagar College of Dental Sciences, Shavige Malleswara Hills, Kumarswamy Layout, Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
7259224735 |
| Fax |
|
| Email |
divya.dukkireddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dukkireddy Divya
Post graduate student Dayananda sagar college of Dental Sciences,
Shavige Malleshwara Hills, Kumarswamy Layout,Bangalore 560078 |
|
|
Primary Sponsor
|
| Name |
Dr Dukkireddy Divya |
| Address |
Dayananda Sagar College of Dental Sciences Shavige malleshwara hills Kumarswamy Layout Bangalore 560078 |
| 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 |
| Dukkireddy Divya |
Dayananda sagar college of dental sciences and Hospital |
Department of Public Health Dentistry
Bangalore
KARNATAKA |
7259224735
divya.dukkireddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dayananda sagar college of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with good general health and who will give informed consent to participate in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlohexidine mouth wash |
0.2% chlorhexidine mouth wash. At baseline stimulated saliva was collected following which tongue coating and salivary pH were measured using color pH indicators and digital pH meter respectively. The participants were asked to rinse their mouth with allocated mouthwashes (10 ml for 1 minute) and expectorate. Salivary and tongue coating pH were recorded immediately and after 30 minutes of rinsing. The same procedure was repeated on 3rd and 7th day. |
| Intervention |
tulsi mouth wash |
tulsi mouth wash prepared from fresh tulsi leaves and At baseline stimulated saliva was collected following which tongue coating and salivary pH were measured using color pH indicators and digital pH meter respectively. The participants were asked to rinse their mouth with allocated mouthwashes (10 ml for 1 minute) and expectorate. Salivary and tongue coating pH were recorded immediately and after 30 minutes of rinsing. The same procedure was repeated on 3rd and 7th day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with good general health and who will give informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Subjects having systemic diseases
Subjects on medication
Subjects having an adverse habit
Subjects who have received any complex therapy within 6 months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimation of saliva and tongue pH of tulsi and chlorhexidine mouthwash participants |
At baseline, 3rd day and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the acceptability of tulsi and chlorhexidine mouthwashes using a questionnaire |
At 7th Day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
04/04/2018 |
| 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
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized, parallel-group study will be conducted among 60 volunteer subjects, who will be randomly assigned into two groups of 30 each (tulsi and chlorhexidine mouthwash). Stimulated saliva will be collected. After this, salivary and tongue coating pH will be measured by a digital pH meter and color pH indicators. Then the participants will be asked to rinse mouth with mouthwash according to the group they are allocated. (10 ml for 1 minute) and expectorate. Salivary and tongue again will be recorded immediately and 30 minutes after rinsing. Same procedure will be repeated on 3rd and 7th day. |