| CTRI Number |
CTRI/2020/10/028466 [Registered on: 19/10/2020] Trial Registered Prospectively |
| Last Modified On: |
15/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Additional use of Probiotics in Diabetics for treatment of gum disease. |
|
Scientific Title of Study
|
Adjuvant use of Probiotics in the management of Periodontitis in Diabetics: A Randomized, Double-blind Clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalyanam Rashmi Durga |
| Designation |
post graduate |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Periodontology
Room No 9
JSS Dental college and Hospital
Bannimantap
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9573638899 |
| Fax |
|
| Email |
rashmikalyanam10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra S |
| Designation |
professor and Principal |
| Affiliation |
JSS Dental college and Hospital |
| Address |
JSS Dental College and Hospital
Bannimantap
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9481872469 |
| Fax |
|
| Email |
drsravindra@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kalyanam Rashmi Durga |
| Designation |
post graduate |
| Affiliation |
JSS Dental college and Hospital |
| Address |
Department of Periodontology
Room No 9
JSS Dental college and Hospital
Bannimantap
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9573638899 |
| Fax |
|
| Email |
rashmikalyanam10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology
Room no 9 JSS Dental college and Hospital
bannimantap
Mysuru |
|
|
Primary Sponsor
|
| Name |
JSSAHER |
| Address |
SS Nagar
Bannimantap
Mysuru |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Kalyanam Rashmi Durga |
Department of Periodontology |
room no 9
JSS Dental college and Hospital
Bannimantap
Mysore
Mysore
KARNATAKA |
9573638899
rashmikalyanam10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental college and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K054||Periodontosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lactobacillus fermentum and bifidobacterium longum probiotics |
dosage; 2 grams/day - two times in a day to be applied as a paste all over the gums for a period of 1 month. |
| Comparator Agent |
sorbitol |
used as placebo in the study .
Dosage;2 grams/day - 2 times in a day to be applied all over the gums in the form of paste for a period of 1 month. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with Periodontal pocket depth ≥ 5mm
Type II Diabetic subjects with glycated haemoglobin range between 7% –10 %
|
|
| ExclusionCriteria |
| Details |
Smokers
Pregnant and lactating mothers
People with a compromised immune system
Antibiotic therapy during the previous 6 months
Systemic diseases other than Diabetes
Subjects taking medications that could interfere with gingival tissue responses
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to reduce subgingival microbiota |
baseline,30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to reduce periodontal pocket depth, plaque,gingival bleeding and inflammation |
baseline,30days,45days,90days |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
26/10/2020 |
| 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="1"
Months="0"
Days="0" |
|
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)?
|
|
Brief Summary
|
This is a randomized double-blind parallel-group placebo-controlled clinical trial which will be conducted among subjects with Periodontitis with or without Diabetes. This study will compare the efficacy of Probiotics lactobacillus fermentum and Bifidobacterium longum in Diabetic subjects with Periodontitis. study population is to be divided in to two groups. A. Periodontitis subjects with Diabetes B. Periodontitis subjects without Diabetes Each group is further divided in to 3 sub-groups, (A1, A2, A3; B1, B2, B3) two test groups and one control group. Subjects will be allotted to different groups based on Computer generated Randomization table In this study, freeze dried Probiotic powder will be supplied to patients. They will be asked to use probiotic powder for around 4 weeks. Among three sub groups, participants in first group (A1, B1) are served with Lactobacillus Probiotic, second group (A2, B2) with Bifidobacterium Probiotic, and the third group (A3, B3) i.e. controls with Sorbitol (Placebo) Subjects will be demonstrated to mix 2 grams of Freeze-Dried probiotic powder with few drops of water to make it in to thick paste and will be instructed to apply it all over the gums and teeth, daily in the morning after their breakfast and before going to bed for around 4 weeks. |