| CTRI Number |
CTRI/2025/11/097407 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to find out if using a new prebiotic with regular gum cleaning helps treat gum disease better. |
|
Scientific Title of Study
|
Evaluation and comparison of the usage of a novel prebiotic as an adjunct to Scaling and Root Planing in the treatment of periodontitis A randomized controlled clinical 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 |
Himani Jagtap |
| Designation |
Post graduate student |
| Affiliation |
Terna Dental College |
| Address |
B-503, Gulmohar CHS II, Plot No 13, Sector 42, Seawoods West, Navi Mumabi
Thane
MAHARASHTRA
400706
India |
| Phone |
9870192212 |
| Fax |
|
| Email |
himanijagtap7240@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dipika Mitra |
| Designation |
Head of the Department, Department of Periodontology |
| Affiliation |
Terna Dental College |
| Address |
Laxmi Building, 2nd floor, flat no 3, Kennedy Bridge, Opera House, Mumbai
Mumbai
MAHARASHTRA
400004
India |
| Phone |
9820180406 |
| Fax |
|
| Email |
drdipikamitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Himani Jagtap |
| Designation |
Post graduate student |
| Affiliation |
Terna Dental College |
| Address |
B-503, Gulmohar CHS II, Plot No 13, Sector 42, Seawoods West, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9870192212 |
| Fax |
|
| Email |
himanijagtap7240@gmail.com |
|
|
Source of Monetary or Material Support
|
| Terna Dental College and Hospital.
Plot no 12, Terna Campus Road, opposite Railway Station, Nerul east , Sector 2, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Terna Dental College and Hospital |
| Address |
Plot No.12, Terna Campus Road, Sector 2, opposite to Railway station, Nerul East
Navi Mumbai - 400706 |
| Type of Sponsor |
Private 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 |
| Dr Himani Jagtap |
Terna Dental college and Hospital |
Terna dental college, Department of periodontology, Room no 101, first floor, terna campus road, sector 22, nerul, navi mumbai- 400706
Thane
MAHARASHTRA |
9870192212
himanijagtap7240@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Ethics Committee |
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 |
Randomised Controlled Clinical Trial |
The test group received 10 mg of inulin powder 5 mg in the morning and 5 mg in the evening mixed with water for 2 weeks before SRP and continued for 2 months, while the control group underwent SRP alone. Clinical parameters, Plaque index PI, Gingival Index GI, Bleeding on Probing BOP, Pocket probing depth PPD, Clinical Attachment Loss CAL, were assessed at baseline, 1 month, and 2 months. |
| Comparator Agent |
Scaling and Root planing |
The Inulin powder, a prebiotic as an adjunct to scaling and root planing, will be compared to the conventional treatment of scaling and root planing alone. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
An individual who will be able to attend the examination for 10 weeks of study.
Pocket depth greater than or equal to 4mm bilaterally
|
|
| ExclusionCriteria |
| Details |
History of Diabetes
Chronic Gastrointestinal Conditions
Current or previous use of antibiotics within the past 4 weeks
Smokers
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Is there any beneficial effect in usage of a novel prebiotic as an adjunct to SRP in reducing the inflammation in chronic periodontitis compared to the SRP alone? |
The clinical periodontal parameters like plaque index PI gingival index GI Pocket depth PD and Clinical attachment loss CAL will be evaluated at Baseline, 4 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/11/2025 |
| 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="2"
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
|
TITLE- Evaluation And Comparison Of The Usage Of A Novel Prebiotic As An Adjunct To Scaling And Root Planing (SRP) Versus SRP Alone In The Non-Surgical Treatment Of Chronic Periodontitis: A Pilot Study. INTRODUCTION- Host modulation using prebiotics like high-molecular-weight inulin enhances gut microbiota, reducing endotoxemia and systemic inflammation. It lowers periodontal inflammation and prevents periodontal tissue degradation by improving immune response. OBJECTIVE – To evaluate and compare the effectiveness of a novel prebiotic as an adjunct to SRP versus SRP alone on clinical periodontal parameters in individuals undergoing nonsurgical periodontal therapy.
PRIMARY HYPOTHESIS- There is a difference between the effectiveness of a novel prebiotic as an adjunct to SRP versus SRP alone in the nonsurgical treatment of Chronic Periodontitis. NULL HYPOTHESIS- There is no difference between the effectiveness of a novel prebiotic as an adjunct to SRP versus SRP alone in the nonsurgical treatment of Chronic Periodontitis.
METHODOLOGY- The test group received 10mg inulin powder (5mg in the morning and 5 mg in the evening) mixed with water for 2 weeks before SRP and continued for 2 months, while the control group underwent SRP alone. Clinical parameters, Plaque index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Pocket probing depth (PPD), Clinical Attachment Loss (CAL), were assessed at baseline, 1 month and 2 months.
|