| CTRI Number |
CTRI/2024/08/073133 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing the efficacy of probiotic tooth paste in periodontitis patients |
|
Scientific Title of Study
|
Evaluation of effectiveness of probiotic tooth paste in periodontitis patients A randomized controlled clinical 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 |
Aswathy B |
| Designation |
PG student |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
Room no 8
Department of Periodontics
PMS College of Dental Science and Research
Golden hills, Vattapara, venkode
thiruvananthapuram
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9778058452 |
| Fax |
|
| Email |
achuvaishnavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ambili R |
| Designation |
Professor and HOD, Department of Periodontics |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
Room no 8
Department of Periodontics
PMS College Of Dental Science and Research
Golden hills, Vattapara, venkode
thiruvananthapuram
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447463676 |
| Fax |
|
| Email |
ambiliranjith@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Aswathy B |
| Designation |
PG Student |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
Room No 8
Department Of Periodontics
PMS College Of Dental Science and Research
Golden hills, Vattapara, venkode
thiruvananthapuram
KERALA
695028
India |
| Phone |
9778058452 |
| Fax |
|
| Email |
achuvaishnavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No ; 8
Department of Periodontics
PMS College of Dental Science and Research
Golden hills venkode ,vattapara ,Thiruvananthapuram
kerala ,India,695028
|
|
|
Primary Sponsor
|
| Name |
Aswathy B |
| Address |
Room no 8
Department of Periodontics
PMS College of Dental Science and Research
Golden hills, Vattapara,Venkode
Thiruvananthapuram,Kerala,India
695028 |
| 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 Ambili R |
PMS College of Dental Science and Research |
Room no 8
PMS College of Dental Science and Research
Golden hills, Vattapara, Venkode ,Thiruvananthapuram,Kerala,India,695028
Thiruvananthapuram
KERALA |
9447463676
ambiliranjith@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, PMS College of Dental Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
colgate tooth paste |
colgate tooth paste twice daily for 1 month |
| Intervention |
probiotic paste |
probiotic paste twice daily for 1 month |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
SyStemically healthy patientS with generalized periodontitis belonging to both SexeS aged between 30 -60 yearS will be Selected from the outpatient clinic of the department of periodontics |
|
| ExclusionCriteria |
| Details |
pregnant and lactating femaleS
Systemic condition that will contraindicate periodontal treatment
periodontal or orthodontic treatment at leaSt 6 month before the Start of the Study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Full mouth plaque Score
Full mouth Bleeding Score
Probing pocket depth |
at base line
at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
fmpS
fmbS
PPD |
at base line
at 4 weeks |
|
|
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)
|
01/10/2024 |
| 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="1"
Months="0"
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
|
Periodontitis is a set of chronic inflammatory disorders of tissues surrounding the teeth that leads to pocket formation and destruction of alveolar bone around the teeth resulting in teeth loss. present study is to evaluate the efficacy of probiotic tooth paste in periodontitis patient after 1 month use of probiotic tooth paste compared to non probiotic paste . |