| CTRI Number |
CTRI/2024/08/072664 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
18/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the effectiveness of probiotic toothpaste in reducing caries causing bacteria in the saliva. |
|
Scientific Title of Study
|
Effect of probiotic toothpaste on Streptococcus Mutans and Lactobacillus in saliva-A randomized control 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 |
Dr Twinkle Sharma |
| Designation |
MDS student |
| Affiliation |
Swami Devi Dyal Hospital and Dental College |
| Address |
Department of Public Health Dentistry
Swami Devi Dyal Hospital and Dental College, Barwala, Golpura,Panchkula
Panchkula
HARYANA
134118
India |
| Phone |
9779117067 |
| Fax |
|
| Email |
sharmadrtwinkle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preety Gupta |
| Designation |
Professor |
| Affiliation |
Swami Devi Dyal Hospital and Dental College |
| Address |
Department of Public Health Dentistry
Swami Devi Dyal Hospital and Dental College, Barwala, Golpura,Panchkula
Panchkula
HARYANA
134418
India |
| Phone |
9876441194 |
| Fax |
|
| Email |
dr.preety86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preety Gupta |
| Designation |
Professor |
| Affiliation |
Swami Devi Dyal Hospital and Dental College |
| Address |
Department of Public Health Dentistry
Swami Devi Dyal Hospital and Dental College, Barwala, Golpura,Panchkula
Panchkula
HARYANA
134118
India |
| Phone |
9876441194 |
| Fax |
|
| Email |
dr.preety86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Devi Dyal Hospital and Dental College,Barwala, Golpura, Panchkula
pincode- 134118
Haryana, India |
|
|
Primary Sponsor
|
| Name |
Dr Twinkle Sharma |
| Address |
Department of Public Health Dentistry
Swami Devi Dyal Hospital and Dental College, Barwala, Golpura,Panchkula
134118
Haryana, India |
| 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 Preety Gupta |
Swami Devi Dyal Hospital and Dental College |
Department of Public Health And Dentistry
Swami Devi Dyal Hospital And Dental College, Barwala,Golpura,Panchkula,134118
Panchkula
HARYANA |
9876441194
dr.preety86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Swami Devi Dyal Hospital And Dental College,Golpura,Barwala,Panchkula,134118 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
probiotic toothpaste |
Purexa Probiotic Toothpaste to be used twice daily for brushing teeth for 30 days.
|
| Comparator Agent |
Regular toothpaste |
Any regular toothpaste without probiotic |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18 to 25 years.
2.Participants with all fully erupted teeth.
3.Participants with inactive caries.
4.No underlying systemic condition.
5.Habit of brushing twice daily.
|
|
| ExclusionCriteria |
| Details |
1.Enrolled in any other clinical trial 30 days prior to randomization.
2.With major dental conditions such as periodontal disease, dental caries and/or xerostomia or systemic diseases which could directly or indirectly affect plaque formation.
3.Using any antimicrobial mouth rinses, probiotics (unrelated to the study) antibiotics or anti-inflammatories medications within one month prior to and during the study.
4.With allergies to any ingredient present in the lorodent probiotic complex.
5.Experiencing any nausea, fever, vomiting, bloody diarrhea or severe abdominal pain within the 30 days prior to commencing the study.
6. Those who were immunocompromised and/or had a major underlying medical condition or ENT problem.
7.Had recent (within the past 45 days) or planned (within the past 90 days) surgery of any kind.
8.With a history of smoking or alcohol consumption.
9.Pregnant and lactating females.
10. Who were unable to make informed consent.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Levels of streptococcus mutans in saliva.
2.Levels of lactobacillus in saliva. |
1.Levels of streptococcus mutans and lactobacillus in saliva at baseline
2.Levels of streptoccus mutans and lactobacillus in saliva after one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Change in levels of Streptococcus mutans and Lactobacillus in saliva after one month of probiotic toothpaste use. |
1.Baseline (Day 0):
Initial saliva sample collection before the start of the intervention to determine the baseline levels of Streptococcus mutans and Lactobacillus.
2.After 30 Days (Day 30):
Follow-up saliva sample collection at the end of the 30-day intervention period to measure the levels of Streptococcus mutans and Lactobacillus and determine the change from baseline. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
29/08/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study will check the effect of probiotic toothpaste on levels of Streptococcus mutans and Lactobacillus in saliva.The study will be conducted at Swami Devi Dyal Hospital And Dental College, and the participants for the study will be choosen from the hostel of dental college randomly. A total of 60 participants will be choosen who met the inclusion criteria. The choosen participants will be randomly divided into two groups of 30 each ,one group will be advised to brush with probiotic toothpaste and the other group with regular toothpaste for 30 days. It will be a double blinded randomized control trial, the participants will be provided with toothpaste in a separate container so that they will not be able to know which toothpaste they are using. The investigator herself will not be aware which participant is using which toothpaste and also saliva samples will be collected with the help of other pg students. Saliva samples will be collected at the baseline and microbiological analysis will be done in the Department of Microbiology of Swami Devi Dyal Hospital And Dental college itself. The participants will be called after on month for again saliva collection. Then the levels of Streptococcus mutans and Lactobacillus will be compared at baseline and after one month. |