| CTRI Number |
CTRI/2017/05/008455 [Registered on: 03/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
26/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Probiotic in treatment of GUM disease |
|
Scientific Title of Study
|
Evaluation of efficacy of Probiotic Bacillus coagulans in the treatment of Gingivitis - A Randomized Placebo controlled double blind trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1193-7041 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aftab Nawab |
| Designation |
PG student |
| Affiliation |
Sri Hasanamba Dental College And Hospital |
| Address |
Department of Periodontics
Sri Hasanamba Dental College And Hospital
Vidyanagar
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9743186962 |
| Fax |
|
| Email |
nawab.aftu@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aftab Nawab |
| Designation |
PG student |
| Affiliation |
Sri Hasanamba Dental College And Hospital |
| Address |
Department of Periodontics
Sri Hasanamba Dental College And Hospital
Vidyanagar
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9743186962 |
| Fax |
|
| Email |
nawab.aftu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Ravindra |
| Designation |
Principal & Head of Department |
| Affiliation |
Sri Hasanamba Dental College And Hospital |
| Address |
Department of Periodontics
Sri Hasanamba Dental College And Hospital
Vidyanagar
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448461209 |
| Fax |
08172233773 |
| Email |
drsravindra@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Unique Biotech Limited,
Plot No. 2, phase II, Alexandria knowledge park, Kolthur village, Shameerpet mandal, Ranga Reddy Dist, Hyderabad - 500078, India. |
|
|
Primary Sponsor
|
| Name |
Dr Aftab Nawab |
| Address |
Department of Periodontics
Sri Hasanamba Dental College And Hospital
Vidyanagar
Hassan |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr S Ravindra |
Principal and Head of Department
Department of Periodontics
Sri Hasanamba Dental College And Hospital
Vidyanagar
Hassan |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aftab Nawab |
Sri Hasanamba Dental College And Hospital |
Room No. 5, Department of Periodontics, Sri Hasanamba Dental College And Hospital, Vidyanagar, Hassan - 573201, Karnataka
Hassan
KARNATAKA |
9743186962
nawab.aftu@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Hasanamba Dental College And Hospital, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Generalised Gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
"Bacillus coagulans" BD for 14 days. |
NIL |
| Comparator Agent |
"Placebo" BD for 14 days. |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female patients aged between 18 and 30 years visiting to Dept of Periodontics, Sri Hasanamba Dental College and Hospital.
Patients diagnosed clinically with Chronic Generalised Gingivits.
Patients having minimum of 12 natural teeth. |
|
| ExclusionCriteria |
| Details |
Patients with systemic illness.
Patients with known or suspected allergy to probiotic strain.
patients allergic to milk and its products.
Patients using Probiotic supplements for other reasons.
Systemic or Local use of Antibiotics in last 1 month.
Smokers and Alcoholics.
Pregnant females and Lactating mothers.
Patients who are not willing to comply with the study protocol.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect on gingival health and reduction of bacterial plaque quantitatively |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Probiotic Bacillus coagulans in prevention of gingivitis and maintenance of gingival health |
21 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/12/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Publication not done yet, waiting for CRTI register number to send study for publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Double blind randomized control trial aimed to evaluate the effectiveness of Probiotic Bacillus coagulans in the treatment of Gingivitis as an adjunct to mechanical debridement. 30 subjects aged between 18 to 30 years, clinically diagnosed to have gingivitis were selected and randomly divided into Group - A (Scaling+Probiotic Bacillus coagulans) and Group - B (Scaling+Probiotic). Clinical parameters data collected at baseline, 7,14,21 days and the obtained data was subjected to statistical analysis and the results were drawn using SPSS computer software. |