| CTRI Number |
CTRI/2022/05/042601 [Registered on: 17/05/2022] Trial Registered Prospectively |
| Last Modified On: |
14/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of efficacy of triphala, chlorhexidine and betadine mouthwash as a preprocedural rinse in reducing microbial count in dental aerosol: a randomized clinical trial. |
|
Scientific Title of Study
|
Comparative Evaluation Of Efficacy Of Triphala, Chlorhexidine And Betadine Mouthwash As A Preprocedural Rinse In Reducing Microbial Count In Dental Aerosol: A Randomized Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SNEHAL VILAS THAMKE |
| Designation |
PG STUDENT |
| Affiliation |
JMFS ACPM DENTAL COLLEGE DHULE |
| Address |
Department Of Public Health Dentistry Jmfs Acpm Dental College Sakri Road Dhule 424002
Dhule
MAHARASHTRA
424002
India |
| Phone |
8806775441 |
| Fax |
|
| Email |
thamkesnehal7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARUN DODAMANI |
| Designation |
Principal, Professor, HOD |
| Affiliation |
JMFS ACPM DENTAL COLLEGE DHULE |
| Address |
Department Of Public Health Dentistry Jmfs Acpm Dental College Sakri Road Dhule 424002
Dhule
MAHARASHTRA
424002
India |
| Phone |
7020669099 |
| Fax |
|
| Email |
drarundodamani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ARUN DODAMANI |
| Designation |
Principal, Professor, HOD |
| Affiliation |
JMFS ACPM DENTAL COLLEGE DHULE |
| Address |
Department Of Public Health Dentistry Jmfs Acpm Dental College Sakri Road Dhule 424002
Dhule
MAHARASHTRA
424002
India |
| Phone |
7020669099 |
| Fax |
|
| Email |
drarundodamani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jmfs Acpm dental college sakri
Road dhule |
|
|
Primary Sponsor
|
| Name |
DR SNEHAL VILAS THAMKE |
| Address |
Department Of Public Health Dentistry Jmfs Acpm dental college sakri
Road dhule 424002
|
| Type of Sponsor |
Other [Self Sponsor] |
|
|
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 SNEHAL VILAS THAMKE |
Jmfs Acpm dental college sakri road dhule |
Jmfs Acpm dental college sakri
Road dhule 424002
Dhule
MAHARASHTRA |
8806775441
thamkesnehal7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.R.V.PATIL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
minimum of 20 permanent teeth required restoration and endodontic treatment |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mouthwash use before endodontic and restorative procedure | (Procedure Reference: mouthwash usage, Procedure details: 0.2% Chlorhexidine, Procedure details: 0.2% Chlorhexidine mouthawash usage before endodontic and restorative procedure)
| | 2 | Intervention Arm | Procedure | - | mouthwash use before endodontic and restorative procedure | (Procedure Reference: mouthwash usage, Procedure details: 6% Triphala mouthwash usage before endodontic and restorative procedure)
| | 3 | Intervention Arm | Procedure | - | mouthwash use before endodontic and restorative procedure | (Procedure Reference: mouthwash usage, Procedure details: 10% Povidone-iodine, Procedure details: mouthwash use before endodontic and restorative procedure)
| | 4 | Comparator Arm (Non Ayurveda) | | - | Triphala, Chlorhexidine and Betadine mouthwash | Triphala, Chlorhexidine and Betadine mouthwash on Streptococcus Mutans, Lactobacillus, Prophyromonas Gingivalis, Actinomyces Viscousus, Fusobacteriu Nucleatum. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals who give consent to participate.
2.Participants having minimum of 20 permanent teeth.
3.Patient having dental problem and who need restoration and endodontic treatment
|
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from any systemic diseases
2.Received antibiotics or nonsteroidal anti-inflammatory drugs in past 1- 3 months
3.Oral prophylaxis within the past three month
4.Participant using other mouthwash
5.Pregnant and lactating mothers
6.Use of smoke and smokeless tobacco products |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is a difference in the efficacy of Triphala, Chlorhexidine and Betadine mouthwash as a preprocedural rinse in reduction of microbial count in dental aerosol |
Before and after giving interventions on same
day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is a difference in the Zone of inhibition of Triphala, Chlorhexidine and Betadine mouthwash on Streptococcus Mutans, Lactobacillus, Prophyromonas Gingivalis, Actinomyces Viscousus, Fusobacterium Nucleatum on agar plate |
Before and after giving interventions on same
day |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/05/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
The present study is to evaluate and compare the efficacy of triphala, chlorhexidine and betadine mouthwash as a preprocedural rinse in reducing microbial count in dental aerosol. The publication will be done after completion of the study.
|