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CTRI Number  CTRI/2025/04/084988 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of antimicrobial property of probiotic toothpaste and probiotic mouthwash  
Scientific Title of Study   A Comparison of Efficacy of Probiotic Toothpaste and Probiotic Mouthwash to Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets: An In Vivo Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jainil Patel 
Designation  MDS Student 
Affiliation  Manubhai dental college 
Address  Department of Orthodontics and Dentofacial Orthopedics, Manubhai Patel Dental College and Hospital,Vishwajyoti Ashram Near.Vidyakunj School, Mujmahuda, Vadodara, Gujarat

Vadodara
GUJARAT
390011
India 
Phone  9998799916  
Fax    
Email  pateljainil919@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Padmaja Arora 
Designation  Professor 
Affiliation  Manubhai Patel Dental College & Hospital 
Address  Manubhai Patel Dental College and Hospital,Vishwajyoti Ashram Near. Vidyakunj School, Mujmahuda, Vadodara

Vadodara
GUJARAT
390011
India 
Phone  9033975429  
Fax    
Email  padmaja2216@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Jainil Patel 
Designation  MDS Student 
Affiliation  Manubhai Patel Dental College & Hospital 
Address  Manubhai Patel Dental College and Hospital,Vishwajyoti Ashram Near. Vidyakunj School, Mujmahuda, Vadodara, Gujarat

Vadodara
GUJARAT
390011
India 
Phone  9998799916  
Fax    
Email  pateljainil919@gmail.com  
 
Source of Monetary or Material Support  
Manubhai Patel Dental College & hospital, Vadodara, Gujarat, India-390011 
 
Primary Sponsor  
Name  Dr Jainil Patel 
Address  8/B Godiji Park society , Opp S.T.Stand,Dehgam Road , Naroda ,Ahmedabad , Gujarat, India. Pin code :- 382330 
Type of Sponsor  Other [SELF] 
 
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 Jainil Patel  Manubhai Patel Dental College and Hospital  Department of Orthodontics and Dentofacial Orthopaedics,Manubhai Patel Dental College and Hospital,Vishwajyoti Ashram Near Vidyakunj School, Mujmahuda
Vadodara
GUJARAT 
9998799916

pateljainil919@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MANUBHAI PATEL DENTAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  malaligned teeth 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  normal Toothpaste and normal mouthwash 
Intervention  probiotic mouthwash  mouthwash in which probiotics are added 
Intervention  probiotic toothpaste  toothpaste in which probiotics are added 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.Patients who received fixed orthodontic treatment for at least three months.

2.No systemic illnesses like diabetes mellitus or immunological diseases like AIDS
Healthy periodontium
 
 
ExclusionCriteria 
Details  Composite restorations and prosthetic crowns on anterior teeth
Patients with Oral Hygiene Index-Simplified (OHI-S) score more than 3
Teeth with developmental anomalies or fluorosis
Patients on medication like phenytoin, or immunosuppressants
Need for anti-inflammatory or antibiotic medication
Pregnant women and smokers
History of frequent vomiting
 
 
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 
Compare antimicrobial property of probiotic mouthwash and probiotic toothpaste   at baseline and at 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   10/03/2026 
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)   Open to Recruitment 
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 - NO
Brief Summary  

54 patients undergoing orthodontic treatment will be selected randomly. These patients will be divided into three groups of 18 patients each: Group 1: - Control Group, Group 2: - Probiotic Toothpaste, Group 3: - Probiotic Mouthwash.

Samples will be collected at two different occasions: Before the study begins (Phase 1)(T0) and After thirty days (Phase 2) (T1).

Plaque specimens will be collected from the labial surfaces immediately surrounding the orthodontic brackets of the maxillary lateral incisors with a sterilized scaler.

To check the anti-microbial effect, plaque sample collected in container will be inoculated in Luria Broth for isolation of S. mutans. Grown culture will be used for serial dilution, plated on chrome agar plates for specific identification of bacterial growth. The different colour colonies will be further inoculated in Luria Broth and will be incubated overnight at 37°C for growth.  Bacterial isolate will be used for genomic DNA extraction, G DNA will be isolated using Genomic DNA extraction kit, followed by 16srdna using universal primers for 16srDNA, PCR samples will be confirmed on (0.8%) agarose gel electrophoresis. PCR sample will be purified using PCR clean up kit. PCR cleanup product will be sent for sequencing.  Protocol used for PCR amplification will be followed accordingly. Thermocycle conditions are 94°C 3 minutes, 94°C 45 seconds, 50°C 60 seconds, 72°C 90 seconds, Repeat steps 2-4 35 times, 72°C 10 minutes, 4°C HOLD.

For Results – Colony Forming Units (CFU) will be counted. 

 
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