| CTRI Number |
CTRI/2025/03/082544 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the capacity of probiotic chewable tablets containing probiotic bacteria on halitosis enzyme levels in patients with bad breath as an adjunct totooth cleaning –a randomized control trial study. |
|
Scientific Title of Study
|
Evaluating the efficacy of probiotic chewable tablets containing lactobacillus reuteri on salivary beta-glucosidase levels in patients with oral malodour as an adjunct to scaling and root planing,a randomized control trial study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LAKSHMI C |
| Designation |
PG STUDENT |
| Affiliation |
Educare Institute Of Dental Sciences |
| Address |
Department of periodontology Educare institute of dental sciences,,College Road, Chattiparamba-Kootlangadi Rd, Kiliyamannil campus, Malappuram, Kerala 676504
Malappuram
KERALA
676504
India |
| Phone |
8095434772 |
| Fax |
|
| Email |
lakshmisanal95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sreekanth Puthalath |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
EDUCARE INSTITUTE OF DENTAL SCIENCES |
| Address |
EDUCARE INSTITUTE OF DENTAL SCIENCES
Malappuram
KERALA
676504
India |
| Phone |
9995693673 |
| Fax |
|
| Email |
srk.puthalath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
LAKSHMI C |
| Designation |
PG Student |
| Affiliation |
EDUCARE INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of periodontology
Educare institute of dental sciences
College Road, Chattiparamba-Kootlangadi Rd, Kiliyamannil campus, Malappuram, Kerala
Malappuram
KERALA
676504
India |
| Phone |
08095434772 |
| Fax |
|
| Email |
lakshmisanal95@gmail.com |
|
|
Source of Monetary or Material Support
|
| EDUCARE INSTITUTE OF DENTAL SCIENCES CHATTIPARAMBA,MALAPPURAM,KERALA,INDIA PIN676504
|
|
|
Primary Sponsor
|
| Name |
Lakshmi C |
| Address |
Educare Institute Of Dental Sciences Chattiparamba P O Malappuram .676504 |
| 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 |
| DR Lakshmi C |
Educare Institute Of Dental Sciences |
EDUCARE INSTITUTE OF DENTAL SCIENCES CHATTIPARAMBA P O MALAPPURAM PIN 676504
Malappuram
KERALA |
09482381367
lakshmisanal95@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Educare Institute Of Dental Sciences ,Chattiparamba P O Malappuram. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
gingivitis and oral malodour |
| Patients |
, (1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Probiotic tablet containing lactobacillus reuteri |
Probiotic chewable tablet containing lactobacillus reuteri to be given to half of the sample population along with scaling and root planing once daily.
the intervention is the chewable tablet (orateri)along with phase 1 therapy |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 25–60 years
2.Both male and female patients
3.Subjective feeling of bad breath.
4.Atleast 16 teeth should be present with a minimum of 4 teeth in each quadrant.
5.Systemically healthy individuals.
6.Who are willing to participate and have signed written consent.
|
|
| ExclusionCriteria |
| Details |
1.Presence of any systemic conditions or debilitating diseases.
2.Smokers, alcoholics, pregnant or lactating women.
3.A recent history or presence of any acute or chronic infections.
4.Patients who had undergone periodontal therapy in the last 6 months.
5.Patients who are paan/tobacco/betel nut users.
6.Patients who are physically or mentally challenged.
7.Patients with periodontal disease or rampant decay with excessive open carious lesions.
8.Patients with Xerostomia.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Salivary beta Glucosidase |
At Baseline,1 Month and 3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| salivary beta glucosidase level decreased in probiotic supplementation. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
29/12/2025 |
| Date of First Enrollment (Global) |
01/04/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The purpose of the study is to evaluate the efficacy of probiotic chewable tablets containing lactobacillus reuteri on salivary β -glucosidase levels in patients with oral malodour as an adjunct to scaling and root planing –a randomized control trial study. The role of probiotics in reducing the level of salivary β glucosidase and thereby in the treatment of halitosis has been investigated. Previous studies have shown the effect of scaling and root planing (SRP) along with probiotics in halitosis patients. This study is intended for the assessment of probiotic therapy as an adjunct to scaling and root planing and its effect on salivary β glucosidase levels in halitosis patients.
|