| CTRI Number |
CTRI/2025/09/094808 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Using Probiotics Alongside Dental Cleaning to Improve Gum Health and Freshen Breath |
|
Scientific Title of Study
|
Assessing the Adjunctive Role of Probiotics in Conjunction with Scaling and Root Planing for management of Chronic Periodontitis and Halitosis: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Pandey |
| Designation |
Senior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Unit of Periodontology
Faculty of Dental Sciences, Institute of Medical Sciences
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09140120152 |
| Fax |
|
| Email |
aishwarya22.ace@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
FARHAN DURRANI |
| Designation |
PROFESSOR |
| Affiliation |
Banaras Hindu University |
| Address |
Unit of Periodontology
Faculty of Dental Sciences, Institute of Medical Sciences
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09140120152 |
| Fax |
|
| Email |
durranif88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Pandey |
| Designation |
Senior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Unit of Periodontology
Faculty of Dental Sciences, Institute of Medical Sciences
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09140120152 |
| Fax |
|
| Email |
aishwarya22.ace@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental sciences, Banaras Hindu University Varanasi |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Aishwarya Pandey |
Faculty of Dental Sciences |
Unit of Periodontology
Faculty of Dental Sciences, Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH |
09140120152
p_aish07@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE BANARAS HINDU UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
probiotic with scaling and root planing |
Participants in the intervention group will receive probiotic supplementation twice daily for 21 days Tab Bifilac Tablets India Private Limited, Chennai. It is a commercially available probiotic preparation combined with prebiotics to enhance its action. Each tablet contains Streptococcus faecalis T 110 JPC 30 million CFU, Clostridium butyricum TO A IHS 2 million CFU, Bacillus mesentericus TO A JPC 1million CFU and Lactobacillus sporogenes IHS 50 million CFU in addition to standard SRP. |
| Comparator Agent |
Scaling and Root Planing |
Scaling and root planning (SRP) procedures will be performed according to established protocols, ensuring thorough removal of subgingival plaque and calculus. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 65 years
Patients having moderate to severe chronic generalized periodontitis (more than equal to 3 mm clinical attachment loss involving more than 30 percent of sites)
Presence of halitosis, confirmed by organoleptic assessment
Patients who had not taken any antibiotics during the previous 3 months or anti-inflammatory drugs in the last month
Patients who had not participated in any clinical trial during the previous month
Who had not undergone any surgical or non-surgical therapy 6 months prior to the study
Ability to provide informed consent for participation in the study.
Patients who agreed for regular follow ups. |
|
| ExclusionCriteria |
| Details |
Patients with history of drug allergy.
Pregnant or breastfeeding women.
Patients wearing orthodontic appliances or any removable prosthesis
Patient with systemic ailments
Patients not consenting to participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Probing Pocket Depth (PPD) from baseline to 1, 2, and 3 months.
Change in Clinical Attachment Level (CAL) over the same intervals.
Reduction in halitosis scores, assessed using organoleptic method. |
Change in Probing Pocket Depth (PPD) from baseline to 1, 2, and 3 months.
Change in Clinical Attachment Level (CAL) over the same intervals.
Reduction in halitosis scores, assessed using organoleptic method. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Gingival Index (GI) from baseline to follow-up visits.
Perceived improvement in breath freshness
Oral discomfort or ease of probiotic use
Incidence of adverse effects or complications related to probiotic use (e.g., gastrointestinal upset, allergic reactions).
Need for retreatment or additional interventions during the 3-month follow-up. |
1 month 2 month 3 month |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the adjunctive efficacy of probiotic supplementation alongside conventional scaling and root planing (SRP) in the management of chronic periodontitis and halitosis. A total of 56 participants with moderate to severe periodontitis and clinically confirmed halitosis will be randomly allocated into two groups: one receiving SRP with probiotics and the other receiving SRP alone. The primary outcomes include changes in probing pocket depth (PPD), clinical attachment level (CAL), and halitosis scores assessed via organoleptic method. Secondary outcomes include gingival index (GI), incidence of adverse effects, and patient-reported outcomes. The study aims to determine whether probiotics can enhance periodontal healing and reduce oral malodor beyond the effects of SRP alone. |