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CTRI Number  CTRI/2024/05/067869 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 22/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparison of efficiency of mouthwash on bacterial levels in saliva and oral health of patient undergoing orthodontic treatment. 
Scientific Title of Study   Comparative evaluation of efficacy of antimicrobial mouthwash and probiotic mouthwash on streptococcus mutans levels in saliva and gingival health of patients undergoing fixed orthodontic treatment. A Randomized Clinical Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gopal Cheke 
Designation  Post graduate student 
Affiliation  Saraswati dhanwantari dental college, pathari road parbhani. 
Address  2nd Floor, department of orthodontics, saraswati dhanwantari dental college pathari road, Parbhani.

Parbhani
MAHARASHTRA
431401
India 
Phone  8669180489  
Fax    
Email  gopalcheke20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Archana Jatania 
Designation  Professor and head of the department 
Affiliation  Saraswati dhanwantari dental college, pathari road parbhani. 
Address  Ground floor, room no 104, staff quarters, Saraswati dhanwantari dental college, pathari road, Parbhani.

Parbhani
MAHARASHTRA
431401
India 
Phone  7719835493  
Fax    
Email  ajatania8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gopal Cheke 
Designation  Post graduate student 
Affiliation  Saraswati dhanwantari dental college, pathari road parbhani. 
Address  2nd Floor, department of orthodontics, saraswati dhanwantari dental college, pathari road, Parbhani.

Parbhani
MAHARASHTRA
431401
India 
Phone  8669180489  
Fax    
Email  gopalcheke20@gmail.com  
 
Source of Monetary or Material Support  
Saraswati dhanwantari dental college, pathari road, Parbhani. 
 
Primary Sponsor  
Name  Dr Gopal Cheke 
Address  Saraswati dhanwantari dental college, pathari road, Parbhani MAHARASHTRA 431401. 
Type of Sponsor  Other [Self-funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gopal Cheke  Saraswati dhanwantari dental college, pathari road, Parbhani.  2nd floor department of orthodontics, saraswati dhanwantari dental college, pathari road Parbhani.
Parbhani
MAHARASHTRA 		 8669180489

gopalcheke20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDDC PBN IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Antimicrobial mouthwash.  Patients in this group will be given 0.2% antimicrobial mouthwash and will be advised to use it twice daily for a period of 1 month through oral route. Patient will be educated about how to use the mouthwash. 
Intervention  Probiotic mouthwash.  Probiotics are live micro-organisms which when administered in adequate amount confers health benefits to the host. Probiotics increases salivary levels of matrix metalloproteinases and tissue inhibitors of metalloproteinases. It naturally produces bacteriocins and other antimicrobial substances like acids or peroxides by preventing oral pathogens from damaging oral tissues. Thus, probiotic mouthwash is used to reduce the bacterial levels in the saliva. Patient is advised to use 5 ml of probiotic mouthwash orally and twice daily for a period of 1 month. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  28.00 Year(s)
Gender  Both 
Details  1. Patient undergoing orthodontic treatment with
preadjusted edgewise appliance (MBT).
2. Overall good general health.
3. Permanent dentition.
4. No anti-inflammatory or antibiotics and mouthwash
used in last week. 
 
ExclusionCriteria 
Details  1. Patient with facial deformities.
2. Patient with severe periodontal problems.
3. History of parafunctional habits.
4. History of maxillofacial surgery or jaw injuries. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To check if the intervention that is probiotic mouthwash has a beneficial effect for reducing bacterial levels in saliva in the patients undergoing orthodontic treatment.  1 day, 30 days. 
 
Secondary Outcome  
Outcome  TimePoints 
To check if the control group shows similar effects as that of the intervention group or less than that.  1 day, 30 days. 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   05/06/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [gopalcheke20@gmail.com].

  6. For how long will this data be available start date provided 20-05-2024 and end date provided 10-05-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

A randomized clinical trial will be conducted on 54 patients undergoing fixed orthodontic treatment. Patients are divided into 3 groups having 18 patients in each group. The groups will be as follows:

 Group 1- Antimicrobial mouthwash group.

 Patients in this group will be given 0.2% antimicrobial mouthwash and will be advised to use it twice daily. Patient will be educated about how to use the

mouthwash. Instructions to maintain proper oral hygiene will be given.

 Group 2- Probiotic mouthwash.

 Patients in this group will be given probiotic mouthwash. They will be advised to use it twice daily. Patient will be educated about how to use the mouthwash. Instructions to maintain proper oral hygiene will be given.

 Group 3- Control group

Patients in this group are used as control group. They will be advised to brush twice daily with toothpaste and instructions to maintain proper oral hygiene will be given.

 

 The saliva samples of the patients will be collected in the sterile containers. The samples will be collected at two intervals that is at 1st day and 30th day. The collected samples will be store in deep freezer at -20 degree Celsius. The collected saliva samples will be then transported to the laboratory for PCR analysis.

 
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