| 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
|
|
|
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
|
|
|
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. |