| CTRI Number |
CTRI/2014/09/005019 [Registered on: 15/09/2014] Trial Registered Prospectively |
| Last Modified On: |
13/09/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Anticaries effect of Probiotic tooth paste |
|
Scientific Title of Study
|
Comparative study of topical effects of Probiotics with a commercial fluoride tooth paste in reducing dental caries in patients with higher salivary Streptococcus mutans levels. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santhosh Kumar |
| Designation |
Postgraduate student |
| Affiliation |
Ragas dental college and hospital |
| Address |
9,Padmanabhan street, Kodambakkam
9,padmanabhan street, kodambakkam
Chennai
TAMIL NADU
600024
India |
| Phone |
919884151839 |
| Fax |
|
| Email |
drsanthoshdentalorg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Kailasam |
| Designation |
Professor and Head of the department |
| Affiliation |
Ragas dental college and hospital |
| Address |
2/102, East coast road, Uthandi, Chennai -600119.
Chennai
TAMIL NADU
600119
India |
| Phone |
9840796200 |
| Fax |
|
| Email |
dr_kailasam@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Santhosh Kumar |
| Designation |
Postgraduate student |
| Affiliation |
Ragas dental college and hospital |
| Address |
9,Padmanabhan street, Kodambakkam
9,Padmanabhan street, Kodambakkam
Chennai
TAMIL NADU
600024
India |
| Phone |
919884151839 |
| Fax |
|
| Email |
drsanthoshdentalorg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ragas dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Ragas dental college and hospital |
| Address |
2/102 east coast road, uthandi, chennai 600119. |
| Type of Sponsor |
Other [private dental college and hospital] |
|
|
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 |
| Santhosh kumar |
Department of Oral medicine and Radiology, Room 1, Ragas dental college and hospital |
2/102 East coast road, Uthandi, Chennai - 600119
Chennai
TAMIL NADU |
9884151839
drsanthoshdentalorg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ragas college Institutional review board and ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with increased caries susceptibility, Salivary Streptococcus mutans level more than 5 million CFU/ml of saliva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fluoride tooth paste - 1ppm of fluoride in 100grams tube |
Commercially available fluoride tooth paste given to patient for 15 days to assess its anti caries action and to compare with other group (probiotic group). Frequency of brushing is twice daily in morning and night. Route of administration is topical oral application. |
| Intervention |
Lactic acid bacillus 200 million spores tablet incoporated in 100 grams tooth paste |
Probiotic Lactobacillus strain in tooth paste form is given for patient with high caries susceptibility in form of tooth paste and outcome is measured by streptococcus mutans colony forming unit count. And it is compared with another group using Fluoride tooth paste. Frequency of brushing twice daily in morning and night.Patient is asked to use the probiotic tooth paste for 15 days and then saliva is evaluated. Route of administration is Topical oral application |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
patients with Streptococcus mutans CFU/ml above 5 million/ml of saliva and DMF index above 5 |
|
| ExclusionCriteria |
| Details |
patients with Streptococcus mutans CFU/ml below 5 million/ml of saliva and DMF index below 5 and edentulous patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is measured by decrease in Streptococcus colony forming units / ml of saliva |
After 15 days usage of tooth paste. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in salivary flow rate, increase in salivary pH, increase in plaque pH. No risk of mortality. |
15 days after tooth paste usage. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
15/09/2014 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study is a prospective clinical trial to analyse the anticaries effect of probiotic tooth paste and compare it with regularly prescibed fluoride tooth paste. Outcome is assessed by decrease in Salivary streptococcus mutans CFU/ml, change in salivary flow rate (both stimulated and unstimulated), change in salivary and plaque pH. Theoretically Probiotic lactobacillus strain competitively inhibits colonization of streptococcus mutans in plaque and ultimately reduced dental caries. This concept is applied in my study. Probiotic tooth paste preparation is given for sample size of 20 randomly selected and it is brushed for 15 days after which outcome is measured. Another group of 20 patients are given fluoride tooth paste and it is brushed for 15 days and outcome measured. Both groups are compared. If the study proves to be statistically significant it will be a boon to dentistry. |