CTRI Number |
CTRI/2022/08/044650 [Registered on: 04/08/2022] Trial Registered Prospectively |
Last Modified On: |
16/06/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Probiotic |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
CLINICAL, MICROBIOLOGICAL AND IMMUNOLOGICAL EVALUATION OF THE EFFICACY OF ORALY ADMINISTERED PROBIOTIC BACILLUS COAGULANS AND STREPTOCOCCUS SALIVARIUS AS AN ADJUVANT TO SCALING AND ROOT PLANING IN PERIODONTITIS PATIENTS: A RANDOMIZED CLINICAL STUDY |
Scientific Title of Study
|
EVALUATION OF THE EFFICACY OF ORALY ADMINISTERED PROBIOTIC BACILLUS COAGULANS AND STREPTOCOCCUS SALIVARIUS AS AN ADJUVANT TO SCALING AND ROOT PLANING IN PERIODONTITIS PATIENTS: A RANDOMIZED CLINICAL STUDY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR AYSHA JEBIN A |
Designation |
SENIOR LECTURER |
Affiliation |
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES |
Address |
DEPARTMENT OF PERIODONTICS,
KRISHNADEVARAYA
COLLEGE OF DENTAL SCIENCES, KRISHNADEVARAYANAGAR,
HUNASAMARANAHALLI,
BENGALURU
KRISHNADEVARAYANAGAR, HUNASAMARANAHALLI, BENGALURU – 562157 Bangalore KARNATAKA 562157 India |
Phone |
9895205190 |
Fax |
08028467084 |
Email |
ayshpathu3@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR AYSHA JEBIN A |
Designation |
SENIOR LECTURER |
Affiliation |
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES |
Address |
DEPARTMENT OF PERIODONTICS,
KRISHNADEVARAYA
COLLEGE OF DENTAL SCIENCES, KRISHNADEVARAYANAGAR,
HUNASAMARANAHALLI,
BENGALURU
KRISHNADEVARAYANAGAR, HUNASAMARANAHALLI, BENGALURU – 562157 Bangalore KARNATAKA 562157 India |
Phone |
9895205190 |
Fax |
08028467084 |
Email |
ayshpathu3@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR AYSHA JEBIN A |
Designation |
SENIOR LECTURER |
Affiliation |
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES |
Address |
DEPARTMENT OF PERIODONTICS,
KRISHNADEVARAYA
COLLEGE OF DENTAL SCIENCES, KRISHNADEVARAYANAGAR,
HUNASAMARANAHALLI,
BENGALURU
KRISHNADEVARAYANAGAR, HUNASAMARANAHALLI, BENGALURU – 562157 Bangalore KARNATAKA 562157 India |
Phone |
9895205190 |
Fax |
08028467084 |
Email |
ayshpathu3@gmail.com |
|
Source of Monetary or Material Support
|
Unique Biotech Ltd,
Plot no 2, phase 2, M N Park, Kolthur village, Shameerpet Mandal, Medchal Malkajgiri Dist, Hyderabad, Telangana, 500101 |
|
Primary Sponsor
|
Name |
Unique Biotech Ltd |
Address |
Plot No2, Alexandra Village Park, Kolthur Village, Shameerpet Mandal, Hyderabad |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
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 AYSHA JEBIN A |
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES |
DEAPARTMENT OF PERIODONTICS, ROOM NO 6, KRISHNADEVARAYANAGAR,
DENTAL DIVISION Bangalore KARNATAKA |
9895205190 08028467084 ayshpathu3@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Comparator Agent |
Control Group Patients receiving Scaling and Root Planing plus PLACEBO sachets/chewable tablets |
Placebo differed from the probiotic in that they lacked the probiotic strain otherwise they were similar with respect to shape, size and colour.
Dosage- Once daily after 1 hour of dinner for 30 days |
Intervention |
Test Group 1 Patients receiving Scaling and Root Planing plus Bacillus coagulans Unique IS-2 chewable tablet of 2 billion cfu strength |
DOSAGE-one chewable tablet of Bacillus coagulans Unique IS-2 once daily after 1 hour of dinner for 30 days |
Intervention |
Test Group 2 Patients receiving Scaling and Root Planing plus Streptococcus salivarius UBSS-01 -2 billion cfu per sachet
|
DOSAGE-one sachet daily after 1 hour of dinner for 30 days, each sachet containing 2 billion CFU of Streptococcus salivarius UBSS-01 |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
a. Age between 30-65years.
b. Patients with stage II and stage III periodontitis according to AAP 2017 classification will be included.10
c)30% or more of sites with probing pocket depth (PPD≥ 4mm and CAL≥4mm
d)A minimum of five teeth with at least one site with CAL and PPD≥4mm.
|
|
ExclusionCriteria |
Details |
a. Antimicrobial therapy in the previous three months
b. Presence of systemic conditions
c. History of smoking
d. Need of prophylactic antibiotic therapy for routine dental procedures.
e. long term administration of anti-inflammatory medications.
f. Usage of probiotics in the past six months before the study.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Probing pocket depth assessed at six sites per tooth.
Microbiological counts of Porphyromonas gingivalis
Microbiological counts of Bacillus coagulans
and Streptococcus salivarius
Levels of IL6. |
BASELINE, 1 MONTH AND 3 MONTHS FOLLOWING PROBIOTIC AND PLACEBO INTERVENTION |
|
Secondary Outcome
|
Outcome |
TimePoints |
Clinical Attachment Level CAL assessed at six sites per tooth.
Plaque Index Silness and Loe 1964
Gingival Index Loe and Silness 1963
|
BASELINE, 1 MONTH AND 3 MONTHS FOLLOWING PROBIOTIC AND PLACEBO INTERVENTION |
|
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)
|
01/09/2022 |
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
|
study not yet started |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Patients will be
recruited for the study based on the Inclusion and Exclusion criteria.
•Patients will
receive information about the etiology of periodontal disease and need for
probiotic therapy and informed written consent will be taken.
•Patients will be
recalled for saliva sample collection for assessment of IL-6 and plaque sample
collection for assessment of Porphyromonas gingivalis, Bacillus coagulans
& Streptococcus salivarius and phase I therapy.
TREATMENT PROTOCOL
•Following
collection of saliva sample and subgingival plaque sample, clinical parameters
like plaque index, gingival index, probing pocket depth and clinical attachment
level will be measured and recorded in a proforma.
•After recording
of baseline parameters, patients will be randomly allocated to test and control
group using a randomization table.
•To maintain full
blinding of results the randomization code will be held by the guide remotely
from all assessments and will not be broken until all data has been collected
and all analysis has been performed.
•The randomization
will be concealed by using sequentially numbered identical appearing containers
of probiotics and placebo group
•All the patients
will receive single visit full mouth debridement using ultrasonic scaler and
Gracey curettes.
•Instructions for
maintaining adequate plaque control and oral hygiene instructions will be
given. Also, the patients will be instructed not to use any other mechanical or
chemical plaque agent during the study period.
•Then the patients
will be supplied with Bacillus coagulans probiotic, Streptococcus salivarius probiotic and placebo tablets to be taken once daily 1 hour after
dinner for 1 month.
•Patients will be
instructed to chew the tablet for 1 minute, swish it around the mouth and then
swallow.
•Clinical
parameters will be recorded again at 1 month and 3 months recall visits.
•The assessment of
clinical parameter at baseline, 1month, and 3months will be carried out by an
independent examiner who is blinded about the treatment groups. IMMUNOLOGICAL
ASSESSMENT:
•Salivary IL-6
will be estimated using commercially available ELISA kit.
•5ml of
unstimulated saliva samples will be collected from each patient. Saliva will be
collected between 9-11 am in all the patients to avoid diurnal variation prior
to subgingival plaque collection and clinical parameter recording to avoid
contamination of the samples with blood.
•All patients will
be asked to avoid food consumption for at least 1 hour before saliva
collection. Patient will be seated on a dental chair and saliva will be
collected over 5 min period with instructions to pool saliva in the floor of
the mouth and passively drool it into a sterile container.
•Collected sample
will be centrifuged at 5000 rpm for 10 minutes.
•Supernatant will
be immediately transferred to a sterile plastic vial and stored at -80°C and
later will be send to laboratory for further processing.
MICROBIOLOGICAL
ASSESSMENT:
•A site with
deepest probing pocket depth will be selected for microbial sampling from every
participant at baseline, 1month and 3months.
•Subgingival
plaque samples will be collected using sterilized curette and then suspended in
1ml normal saline solution and will be subjected to evaluation using Real Time
Polymerase chain reaction for P gingivalis, B. coagulans & Streptococcus
salivarius |