| CTRI Number |
CTRI/2024/11/076939 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the expression of anti-microbial resistance genes in subgingival plaque samples in generalized periodontitis patients before and after using probiotic toothpaste. |
|
Scientific Title of Study
|
Impact of Oral Probiotic Paste on Antimicrobial Resistance in Patients with Generalized Periodontitis: A Quasi-Experimental 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 |
AMRUTHA THANKAM BABUJI |
| 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, Venkode, Vattapara
THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA
695028
India |
| Phone |
8921091606 |
| Fax |
|
| Email |
thankamamrutha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMBILI R |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
ROOM NO. 8
Department of Periodontics
PMS College of Dental Science and Research, Golden Hills, Venkode, Vattapara.
THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447463676 |
| Fax |
|
| Email |
ambiliranjith@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
AMBILI R |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
ROOM NO. 8
Department of Periodontics
PMS College of Dental Science and Research, Golden Hills, Venkode, Vattapara
THIRUVANANTHAPURAM
KERALA
695028
India |
| Phone |
9447463676 |
| Fax |
|
| Email |
ambiliranjith@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PROOF PROBIOTIC TOOTH PASTE
Room No.8
Department of Periodontics
PMS College of Dental Science and Research, Golden Hills, Venkode,Vattapara, Thiruvananthapuram, 695028 |
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
ROOM NO 8
DEPARTMENT OF PERIODONTICS
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH,GOLDEN HILLS,VENKODE,VATTAPARA
THIRUVANANTHAPURAM |
| Type of Sponsor |
Other [] |
|
|
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 AMRUTHA THANKAM BABUJI |
PMS College of Dental Science and Research |
Room No. 8
Department of Periodontics
PMS College of Dental Science and Research, Golden Hills, Venkode, Vattapara
Thiruvananthapuram
Thiruvananthapuram
KERALA |
8921091606
thankamamrutha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,PMS College of Dental Science ana Research, Vattapara, Thiruvananthapuram, 695028 |
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 |
1 month twice daily orally |
| Intervention |
proof probiotic tooth paste |
1 month twice daily orally |
|
|
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 |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating females
• Immunocompromised patient
• Periodontal or orthodontic treatment at least 6 months before the start of the
study
• Use of antibiotics, corticosteroids, and antiâ€inflammatory drugs within 3 months
before sampling.
• Smokers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expression of ermT and vanX genes |
1 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plaque index, bleeding on probing |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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
|
Recently probiotics have emerged as a promising adjunct to scaling and root planing. However, its clinical benefits are still not proven as per existing evidence. Recent in vitro studies have reported antimicrobial resistance genes in commonly used oral probiotic lozenges. However clinical studies have not been carried out in this regard. This study intends to evaluate the impact of probiotic toothpaste on anti-microbial resistance genes of microorganisms in dental plaque. |