| CTRI Number |
CTRI/2022/08/044814 [Registered on: 23/08/2022] Trial Registered Prospectively |
| Last Modified On: |
22/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [Mouthwashes ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of five mouthwashes in reducing viral load and bacterial colonies in oral cavity |
|
Scientific Title of Study
|
Comparative evaluation to study efficacy of mouthwashes in reducing viral load and bacterial colonies in oral cavity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ekta Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Inderprastha Dental College and Hospital, Uttar Pradesh |
| Address |
Third floor, room no.-2,Department of orthodontics and dentofacial orthopaedics,Inderprastha dental college and hospital,46/1, Sahibabad Industrial Area Site 4,Sahibabad, Ghaziabad, 201010
Third floor, room no.-2,Department of orthodontics and dentofacial orthopaedics, Inderprastha dental college and hospital ,46/1,Sahibabad Industrial Area Site 4, Sahibabad,Ghaziabad,201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9891143465 |
| Fax |
|
| Email |
dr.ekta.vashishtha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ekta Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Inderprastha Dental College and Hospital, Uttar Pradesh |
| Address |
third floor, room no.-2,Department of orthodontics and dentofacial orthopaedics,Inderprastha dental college and hospital,46/1, Sahibabad Industrial Area Site 4,Sahibabad, Ghaziabad, 201010
hird floor, room no.-2,Department of orthodontics and dentofacial orthopaedics,Inderprastha dental college and hospital,46/1, Sahibabad Industrial Area Site 4,Sahibabad, Ghaziabad, 201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9891143465 |
| Fax |
|
| Email |
dr.ekta.vashishtha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul paul |
| Designation |
Head Of the Department ( Department of Orthodontics) |
| Affiliation |
Inderprastha Dental College and Hospital, Uttar Pradesh |
| Address |
Third floor, room no.-2,Department of orthodontics and dentofacial orthopaedics,Inderprastha dental college and hospital,46/1, Sahibabad Industrial Area Site 4,Sahibabad, Ghaziabad, 201010
Third floor, room no.-2,Department of orthodontics and dentofacial orthopaedics,Inderprastha dental college and hospital,46/1, Sahibabad Industrial Area Site 4,Sahibabad, Ghaziabad, 201010
East
DELHI
201010
India |
| Phone |
9810292498 |
| Fax |
|
| Email |
drrahulpaulipdc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ekta sharma(self),third floor room no-2,department of orthodontics and dentofacial orthopaedics,inderprastha dental college and hospital,46/1 Sahibabad Ghaziabad 201010 |
|
|
Primary Sponsor
|
| Name |
Dr Ekta Sharma |
| Address |
T 107 Nipun Saffron Valley, Sahibabad, Ghaziabad 201005 |
| Type of Sponsor |
Other [2nd year Post Graduate Student] |
|
|
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 Vineet Golchha |
Inderprastha Dental College & Hospital |
46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
UTTAR PRADESH |
9990156222
orthovineet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Inderprastha Dental College & Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers without any systemic
illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mouthwashes namely
1)Chlohex
2) Purexa
3) Cepacol
4) Betadine
5) Colgate Plax |
Patients will be divided into five groups and will be asked to rinse with these mouth washes. (One mouthwash per group one month prior and after bonding. |
| Comparator Agent |
Viral load and bacterial colonies |
Amount of Viral load and bacterial colonies will be assessed pre and post rinsing one month before and after bonding |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individual understanding and accepting trial |
|
| ExclusionCriteria |
| Details |
Individuals on medication or having any systemic illness.
Pregnant or lactating females.
Patients already using mouthwash regularly more than once a week
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the expected primary outcome of this study is that group 2(hydrogen peroxide)will reduce the viral load in oral cavity the more as compared to other groups in the samples collected pre and post bonding. |
4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the expected secondary outcome is to check that group 2(hydrogen peroxide) will reduce bacterial colonisation more as compared to the other groups |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
28/08/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
Aim : To evaluate the efficacy of different mouthwashes for reducing viral load and bacterial colonies in oral cavity .
Methodology: 75 patients coming to Department of Orthodontics and Dentofacial Orthopaedics, Inderprastha Dental College and Hospital for orthodontic treatment will be considered for the study. All the volunteers were divided into five groups: 15 subjects per group. Subjects’ saliva was collected early in the morning after normal oral hygienic procedures. Spitting method was employed in which the subjects were seated with head inclined forward so that the saliva will collect in the floor of the mouth from where it is spat into a 20 ml sterile specimen bottle for 5 minutes. The saliva samples collected in the before the rinse for each group served as the control and the samples collected after 5minutes of use mouth rinse chlorhexidine, ,hydrogen peroxide, cetylpyridinium chloride and povidine-iodine as the experimental.. All five Mouthwashes were used in definite concentration 1.chlorhexidine brand name chlorhex-0.2% 2. hydrogen peroxide brand name hydroxyl-3% 3.cetylpyridinium chloride brand name mcclean-0.07% 4. Povidine-iodine brand name betadine-7% 5. Colgate Plax Subects in each group will be asked to rinse their mouth using respective mouthwashes and their samples will be collected after two hours of rinsing using saliva collection kit during first visit and one month after bonding. Sample will be stored using dry ice at - 80 degree. Then sample will be tested for the load of rhinovirus using ELISA and bacterial load will be detected by measuring CFU on blood agar medium.
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