| CTRI Number |
CTRI/2026/01/100487 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Adding Probiotics to Routine Dental Cleaning on Gum Health in Adults with Gum Disease(Periodontitis) |
|
Scientific Title of Study
|
Efficacy of Probiotics as an Adjunct to Scaling and Root Planing in Periodontitis: A Randomized, Double-Blind, Placebo-Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PP02 version: 2 Date: 20-12-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mehdi Ali Mirza |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Room No: 4055, 4th Floor, Department of Pharmacology, Academic and Administrative block, Sanathangar, Hyderabad
Hyderabad
TELANGANA
500036
India |
| Phone |
9160368850 |
| Fax |
|
| Email |
mehdialimirza@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mehdi Ali Mirza |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Room No: 4055, 4th Floor, Department of Pharmacology, Academic and Administrative block, Sanathangar, Hyderabad
Hyderabad
TELANGANA
500036
India |
| Phone |
9160368850 |
| Fax |
|
| Email |
mehdialimirza@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mehdi Ali Mirza |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Room No: 4055, 4th Floor, Department of Pharmacology, Academic and Administrative block, Sanathangar, Hyderabad
Hyderabad
TELANGANA
500036
India |
| Phone |
9160368850 |
| Fax |
|
| Email |
mehdialimirza@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mehdi Ali Mirza |
| Address |
Room No 4055, 4th Floor, Academic and Adminstrative block, ESIC Medical College and Hospital, Sanathnagar, Hyderabad-500038 |
| 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 Mehdi Ali Mirza |
ESIC Medical College and Hospital |
room 4055, fourth floor, Academic and administrative block, Sanathnagar, Hyderabad
Hyderabad
TELANGANA |
9160368850
mehdialimirza@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESIC Medical College and Hospital and ESIC Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K054||Periodontosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparable identical placebo chewable tablets without active ingredients. |
Two chewable tablet daily one in the morning, one at bed time after brushing the teeth.for 12 weeks |
| Intervention |
L. reuteri UBLRu-87 Chewable tablets |
Two chewable tablet daily one in the morning, one at bed time after brushing the teeth.for 12 weeks |
| Intervention |
multi-strain probiotic blend containing S.salivarius UBSS-01, L.salivarius UBLS -22, L.plantarum UBLP-40,L.reuteri UBLRu-87,B.coagulans Unique IS-2, FructoOligoSaccharides, Zinc and Vitamin D3. |
Two chewable tablet daily one in the morning, one at bed time after brushing the teeth.for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Three or more natural teeth required per quadrant, with third molar exclusion
2. Moderate to severe periodontitis with the PD more than or equal to 4mm |
|
| ExclusionCriteria |
| Details |
1. individuals who are on any probiotic supplements for the past 3 months
2. individuals who has received antimicrobial/ periodontal therapies in last 3 months.
3. Those who receive oral hygiene treatment.
4. Patients with dental emergencies requiring antibiotic therapy such as pain, abscess, etc
5. Patients with history of systemic disease, smoking, allergy to lactose and fermented milk products
6. Pregnant and lactating females or those planning pregnancy during the treatment period. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in probing pocket depth (PPD) |
Day0, 28 and 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in gingival recession (REC), bleeding on probing (BOP), , Winkel tongue coating index (WTCI), plaque index (PI) improvement in clinical attachment level (CAL) and reduction in volatile sulfur compounds (bad breath). |
Day 0, 28 and 84 (Volatile sulfur compounds- on day 56 also) |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
19/01/2026 |
| 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="6"
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 is randomized double blind placebo controlled three arm trial. individuals meeting eligibility criteria after ICF signing will be randomly allocated to either group1 receiving on chewable probiotic tablet containing Lactobacillus reutri UBLRu-87, twice daily for 84 days. Group 2 will receive one chewable probiotic tablet containing a blend of Streptococcus salivarius UBSS-01, Lactobacillus salivarius UBLSS-22, Lactobacillus plantarum UBLP-40, Lactobacillus reuteri UBLRu-87, Bacillus coagulans, fructo-oligosaccharides, elemental zinc (from zinc citrate), vitamin D3, taken twice daily for 84 days.Group 3 will receive one chewable placebo tablet identical in appearance to the probiotic tablets, taken twice daily for 84 days.There will be total 5 visits- Visit -1 (Day -1); Visit 2 (Day 0 -Baseline; Visit 3 (Day 28); Visit 4 (Day 56); Visit 5 (Day 84). The primary outcome measures will be changes in probing pocket depth (PPD) and clinical attachment level (CAL) following periodontal therapy in patients with moderate to severe periodontitis and halitosis. Secondary outcome measures will include bleeding on probing (BOP), gingival index (GI), plaque index (PI), Winkel Tongue Coating Index (WTCI), and levels of volatile sulfur compounds (VSCs) associated with halitosis. |