| CTRI Number |
CTRI/2020/10/028206 [Registered on: 01/10/2020] Trial Registered Prospectively |
| Last Modified On: |
30/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of anti-decay mouthwash and lozenges in children highly prone to tooth decay. |
|
Scientific Title of Study
|
Effectiveness of probiotic mouthwash and Anti CA gtf Ig Y lozenges in high caries risk children using cariogram- A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRMU/M&HS/SRMDC/2020/PG/024 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KABITA SAHOO |
| Designation |
PG STUDENT |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM
SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM
Chennai
TAMIL NADU
600089
India |
| Phone |
7008341911 |
| Fax |
|
| Email |
sahookabita27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHANKAR P |
| Designation |
READER |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM
SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM
Chennai
TAMIL NADU
600089
India |
| Phone |
9884585808 |
| Fax |
|
| Email |
pedoshankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KABITA SAHOO |
| Designation |
PG STUDENT |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM
SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM
Chennai
TAMIL NADU
600089
India |
| Phone |
7008341911 |
| Fax |
|
| Email |
sahookabita27@gmail.com |
|
|
Source of Monetary or Material Support
|
| KABITA SAHOO, SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM |
|
|
Primary Sponsor
|
| Name |
KABITA SAHOO |
| Address |
SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM |
| 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 |
| KABITA SAHOO |
SRM DENTAL COLLEGE, RAMAPURAM |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY ,BHARATHI SALAI, RAMAPURAM
Chennai
TAMIL NADU |
7008341911
sahookabita27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with high caries risk |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anti CA gtf lozenges |
15 days, oral administration,one tablet each for two times a day |
| Comparator Agent |
Flouridated toothpaste |
toothpaste to be used twice daily ,30 days |
| Intervention |
probiotic mouthwash |
powder form which is mixed in water to gargle, done once before going to bed at night , for 30 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with high risk caries
2. Children of age group 6-9 years of age
3. Children willing to participate
|
|
| ExclusionCriteria |
| Details |
1. Children with any systemic disease.
2. Subjects who have taken antibiotics or mouthwash or corticosteroids in the past 30 days
3. Subjects who have a history of sensitivity to any drugs, mouthwash or egg
4. Subjects who have removable prostheses or an orthodontic appliance
5. Subjects who have undergone professional measures to remove plaque and calculus in the past 15 days
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Microbial Count |
1 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cariogram Outcome |
The change in the overall caries risk profile after a 30 day intervention |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/10/2020 |
| 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="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental Caries is the most prevalent multifactorial disease worldwide. Cariogram graphically represents the risk factors for dental caries and to what extent these factors may affect the caries risk for that particular patient. Aim- To assess the change in the caries risk profile in high caries risk children after 30 days intervention with probiotic mouthwash and Anti-CA gtf lozenges |