| CTRI Number |
CTRI/2018/01/011191 [Registered on: 08/01/2018] Trial Registered Prospectively |
| Last Modified On: |
05/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of hand sanitizer and liquid soap alone or in combination in decreasing the germs of the hand. |
|
Scientific Title of Study
|
Comparative efficacy of hand disinfection potential of hand sanitizer and liquid soap alone or in combination: a randomized controlled trial |
| Trial Acronym |
Hand disinfection |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umesh Wadgave |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed University Dental College and Hospital Sangli |
| Address |
Department of Public Health Dentistry, Bharati Vidyapeeth Deemed University Dental College and Hospital Sangli
Sangli
MAHARASHTRA
416416
India |
| Phone |
8805835602 |
| Fax |
|
| Email |
dr.w.umesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Wadgave |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed University Dental College and Hospital Sangli |
| Address |
Department of Public Health Dentistry, Bharati Vidyapeeth Deemed University Dental College and Hospital Sangli
Sangli
MAHARASHTRA
416416
India |
| Phone |
8805835602 |
| Fax |
|
| Email |
dr.w.umesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Wadgave |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed University Dental College and Hospital Sangli |
| Address |
Department of Public Health Dentistry, Bharati Vidyapeeth Deemed University Dental College and Hospital Sangli
Sangli
MAHARASHTRA
416416
India |
| Phone |
8805835602 |
| Fax |
|
| Email |
dr.w.umesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University Dental College and Hospital, Sangli |
|
|
Primary Sponsor
|
| Name |
Umesh Wadgave |
| Address |
Bharati Vidyapeeth Deemed University Dental College & Hospital, Sangli |
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 |
| Umesh Wadgave |
Bharati Vidyapeeth Dental College and Hospital, Sangli |
Dept. of Public Health Dentistry, Bharati Vidyapeeth Dental College and Hospital, Sangli
Sangli
MAHARASHTRA |
8805835602
dr.w.umesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Medical College and Hospital, Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hand disinfection |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hand Santizer |
2-Propanol IP 45.0 g, 1-Propanol 30.0 g, Mecetroniumethylsulphate 0.2 g, skin protecting substance and emollients (Sterillium). |
| Intervention |
Liquid Soap Hand wash |
Aqua, Sodium laureth sulfate, Glycol Stearate, Methylisothiazolinone and Sodium hydroxide (Dettol Original Liquid Handwash). |
| Comparator Agent |
Liquid soap hand wash followed by hand sanitizer |
Dettol Original Liquid Handwash (Handwash) Sterillium (Hand Sanitizer) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers from 3rd year, 4th year dental students and Interns from Bharati Vidyapeeth Dental College and Hospital, Sangli.
Participants who are willing to give informed consent.
Participants of both genders
|
|
| ExclusionCriteria |
| Details |
Participants with any fresh injury or wound on hands and
History of allergy to liquid soap or hand sanitizer
Participants who are willing to give informed consent
|
|
|
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
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand disinfection (Bacterial Count) |
T1: Baseline (Just before hand washing)
T2: 5 minutes after hand washing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/03/2018 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, parallel group trial comparing the hand disinfection efficacy of Hand sanitizer and liquid soap among dental students. Volunteers will be instructed to contaminate their hands by touching typical everyday surfaces (i.e. Door handles, tables, stools, routine dental instruments and dental chair) with both hands prior to testing. A swab from each participants’ hand will be taken both before and after the intervention. Swab are cultured on agar plates to determine a maximum spectrum of microbes present.
|