| CTRI Number |
CTRI/2019/10/021489 [Registered on: 01/10/2019] Trial Registered Prospectively |
| Last Modified On: |
29/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of Locally Delivered Probiotic Mixture In The Management Of Chronic Periodontitis. |
|
Scientific Title of Study
|
A Randomized Single Blind Placebo-Controlled Clinical Trial To Compare The Clinical Efficacy Of Locally Delivered Probiotic Mixture As An Adjunct To Non-Surgical Periodontal Therapy In The Management Of Chronic Periodontitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Singh |
| Designation |
Post Graduate |
| Affiliation |
Shree Bankey Bihari Dental College and Research Centre |
| Address |
Department of Periodontics
Shree Bankey Bihari Dental College and Research Centre 0.5 Km Ahead Masuri Canal NH-24 Masuri Ghaziabad-201302 UP INDIA
Ghaziabad
UTTAR PRADESH
201302
India |
| Phone |
7838482477 |
| Fax |
|
| Email |
drankitasingh91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Gupta |
| Designation |
Professor & Head of Department |
| Affiliation |
Shree Bankey Bihari Dental College and Research Centre |
| Address |
Department of Periodontics
Shree Bankey Bihari Dental College and Research Centre 0.5 Km Ahead Masuri Canal NH-24 Masuri Ghaziabad-201302 UP INDIA
Ghaziabad
UTTAR PRADESH
201302
India |
| Phone |
9971581158 |
| Fax |
|
| Email |
neha.jalaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Singh |
| Designation |
Post Graduate |
| Affiliation |
Shree Bankey Bihari Dental College and Research Centre |
| Address |
Department of Periodontics
Shree Bankey Bihari Dental College and Research Centre 0.5 Km Ahead Masuri Canal NH-24 Masuri Ghaziabad-201302 UP INDIA
Ghaziabad
UTTAR PRADESH
201302
India |
| Phone |
7838482477 |
| Fax |
|
| Email |
drankitasingh91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Unique Biotech limited,Hyderabad |
|
|
Primary Sponsor
|
| Name |
Department of Periodontics |
| Address |
Shree Bankey Bihari Dental college Research Institute
0.5 Km Ahead Masuri Canal,NH-24 Masuri Ghaziabad-201302 UP India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Unique Biotech limited |
G-43 Madhura Nagar,Yousufguda Hyderabad,Telangana- 500038 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Singh |
Shree Bankey Bihari Dental College and Research Centre Department of Periodontics, Room number-402 |
0.5 km Ahead Masuri canal NH-24,Masuri-201302 Ghaziabad
Ghaziabad
UTTAR PRADESH |
7838482477
drankitasingh91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Bankey Bihari Dental College & Research Centre Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy chronic periodontitis patient having at least two periodontal pockets in two different quadrant |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Proracare Placebo Sachet |
It is a white colour powder with mint flavour. |
| Intervention |
Proracare Probiotic Sachet
|
Proracare probiotic :
Each 1.0g sachet contains
Lactobacillus salivarius - 0.5 billion cfu
Lactobacillus plantarum-0.5 billion cfu
Lactobacillus reuteri -0.5 billion cfu
Streptococcus salivarius 0.25 billion
Bacillus coagulans- 0.25 billion.
Following scaling and root planing,small increments of the preparation will be taken and mixed it with distilled water until a paste like consistency will be achieved.The mode of administartion will be with a 2ml Dispovan syringe.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy chronic periodontitis patients having at least two periodontal pockets ≥5 mm in each quadrant. |
|
| ExclusionCriteria |
| Details |
Medically compromised patients
Smokers
Subjects having received any forms of surgical, non-surgical therapy in the 6 month period prior to the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pocket probing depth
Gain in clinical attatchment levels |
At Baseline,1 week,3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Plaque index scores
Reduction in Modified gingival index scores |
At Baseline,1 week,3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
07/10/2019 |
| Date of Study Completion (India) |
07/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No relevant data |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized single blind Placebo-controlled clinical interventional trial comparing the clinical efficacy of locally delivered probiotic mixture as an adjunct to non-surgical periodontal therapy in patients with chronic periodontitis that is being conducted in a single centre in Ghaziabad, Uttar Pradesh India. From a study pool of 50 subjects,30 subjects were selected from the out patient department of shree bankey bihari dental college,Ghaziabad based on the inclusion and exclusion criteria.In all the 30 subjects,Two interdental suprabony periodontal pockets of greater than or equal to 5mm were selected from two different quadrants and were allocated into test group and control group based on the coin toss system. In control sites,Scaling and root planing was done at baseline followed by placement of placebo mixture while in the test sites scaling and root planing was done followed by placement of probiotic mixture at baseline.All the therapies were performed by the designed operator for the sake of uniformity.Subsequently all the clinical parameters(i.e Plaque index,Gingival index,Clinical attatchment levels and probing depth) were recorded and evaluated at at baseline, one week,3 months,6 months by another operator who was blinded to the nature of site. Follow up of the subjects were done till 20 March 2020 i.e before lockdown being implemented in the nation. Further status of the clinical trial will be updated as soon as possible. |