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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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