| 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
|
|
|
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
|
|
|
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. |