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CTRI Number  CTRI/2019/12/022226 [Registered on: 03/12/2019] Trial Registered Prospectively
Last Modified On: 27/11/2019
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   A study evaluating the efficacy of probiotics in the treatment of bad breath in patients with gum problems.Probiotic are dietary suplements containing live bacteria that are beneficial to the body. 
Scientific Title of Study   A Randomized control trial evaluating the efficacy of probiotics in treatment of halitosis in chronic periodontitis patient : A clinico microbiological study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ansu Emmanuel 
Designation  post graduate 
Affiliation  coorg institute of dental sciences 
Address  Coorg institute of dental sciences K K campus maggula village virajpete coorg dist 571218

Kodagu
KARNATAKA
571218
India 
Phone  9482931218  
Fax    
Email  ansumolemmanuel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit walvekar 
Designation  professor and HOD 
Affiliation  coorg institute of dental sciences 
Address  Coorg institute of dental sciences K K campus maggula village virajpete coorg dist 571218

Kodagu
KARNATAKA
571218
India 
Phone  9480085687  
Fax    
Email  amitakw@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit walvekar 
Designation  professor and HOD 
Affiliation  coorg institute of dental sciences 
Address  Coorg institute of dental sciences K K campus maggula village virajpete coorg dist 571218

Kodagu
KARNATAKA
571218
India 
Phone  9480085687  
Fax    
Email  amitakw@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Periodontics and Implantology,Coorg Institute of Dental Sciences SH 88B Kodagu Coorg District Virajpet Karnataka 571218 
 
Primary Sponsor  
Name  Dr Ansu Emmanuel 
Address  Department of Periodontics and Implantology,Coorg Institute of Dental Sciences SH 88B Kodagu Coorg District Virajpet Karnataka 571218 
Type of Sponsor  Other [self] 
 
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 
ansu emmanuel  coorg institute of dental sciences  Roon No.4 Department Of Periodontics & implantology, K K campus, maggula village, virajpet coorg dist 571218
Kodagu
KARNATAKA 
9482931218

ansumolemmanuel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  chronic periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  placebo chewable gums  placebo chewable tablets once daily 
Intervention  probiotics tablrt  probiotic chewable tablets once daily for 3 months 
Comparator Agent  scaling and root planing  Debridement of supragingival and subgingival calculus 
Intervention  scaling and rootplaning  Debridement of supragingival and subgingival calculus 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subjects with a minimum complement of 20 teeth.
2.systemically healthy patients
3.patient diagnosed with chronic periodontitis
clinically evident with at least 2 teeth 4.showing probing depth ≥5mm
5.patient with clinically perceptible halitosis
 
 
ExclusionCriteria 
Details  1.Subjects with any systemic disease.
2.Subjects received periodontal treatment in last 6 months
3.Subjects who have received antibiotics/anti-inflammatory drugs/steroids in the recent past
4.Pregnant or lactating women.
5.Subjects who are tobacco users.
6.Patients allergic to lactate products
7.Patient deemed uncooperative
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Expecting reduction in number of anaerobic bacteria and halitosis  baseline, 1 month and 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
gradual reduction in number of anaerobic bacteria and there by decrease in halitosis  baseline, 1 month and 6 month 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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   Phase 1 
Date of First Enrollment (India)   23/12/2019 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

          Periodontitis is a chronic inflammatory disease that affects the supporting structures of teeth, resulting in tooth loss. Halitosis (fetor oris) is a general term used to describe an unpleasant or offensive odour emanating from the oral cavity. Periodontal disease results in an unpleasant odour

           Probiotics are “live microorganisms which when administered in adequate amounts confer a health benefit on the host” (WHO 2002). In oral cavity, probiotics can create a biofilm, acting as a protective lining for oral tissues against oral diseases.

This study evaluates the efficiency of probiotics in preventing halitosis in chronic periodontitis patients.

          A total number of 26 cases of chronic periodontitis with halitosis will be selected randomly by self-evaluation (problematic, very strong, strong, moderate, light) and  organoleptic method (0-5point score) and will be divided in to test group A(SRP+ Probiotics) and control group B (SRP+ Placebo) including both males and females in the age group of 20-70 years. The study will be explained to each of the patients selected randomly and his/her written consent will be obtained prior to the commencement of the study. After qualifying for the study, 5 clinical variables will be evaluated at the baseline by the examiner who will be recording all measurements in a single blind design including probing pocket depth (PPD), clinical attachment level (CAL), sulcus bleeding index (SBI), Periodontal index (PI), wrinkel tongue coating index (WTCI) .After the initial clinical evaluation subgingival samples will be collected by inserting two consecutive paper points in to gingival crevices for 10 seconds. Then the samples will be given for the analysis of microbiological data, colony forming unit (CFU) per ml for total anaerobic flora .After the sample collection scaling and root planing will be done on both groups. The patients in group A will be advised to use probiotic tablets and group B will be given placebo. Patient will be recalled 4weeks and 8weeks after initial scaling and root planning and the above measurements will be repeated and samples are collected at 1st and 3rd months and given for microbiological investigation.

 
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