| CTRI Number |
CTRI/2025/09/094730 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical efficacy of lactobacillus salivarus probiotic gel and chlorhexidine gel along with scaling and root planing. |
|
Scientific Title of Study
|
Comparative evaluation of lactobacillus salivarius probiotic gel and chlorhexidine gel as an adjunct to scaling and root planing. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Golapala Naga Aishwarya |
| Designation |
PG student |
| Affiliation |
Sibar institute of dental sciences guntur |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur.
ANDHRA PRADESH,522509 India
ANDHRA PRADESH,522509 India
Guntur
ANDHRA PRADESH
522101
India |
| Phone |
07093156626 |
| Fax |
|
| Email |
aishwaryagolapala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anumula Deepa |
| Designation |
Professor |
| Affiliation |
Sibar institute of dental sciences guntur |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur.
ANDHRA PRADESH,522509 India
ANDHRA PRADESH,522509 India
Guntur
ANDHRA PRADESH
522101
India |
| Phone |
9618501146 |
| Fax |
|
| Email |
anumala.deepas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anumula Deepa |
| Designation |
Professor |
| Affiliation |
Sibar institute of dental sciences guntur |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur.
ANDHRA PRADESH,522509 India
ANDHRA PRADESH,522509 India
Guntur
ANDHRA PRADESH
522101
India |
| Phone |
9618501146 |
| Fax |
|
| Email |
anumala.deepas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences
Takellapadu
Guntur
Andhra pradesh
India
522509 |
|
|
Primary Sponsor
|
| Name |
Golapala Naga Aishwarya |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur. |
| 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 Golapala Naga Aishwarya |
Sibar institute of dental sciences guntur |
Room no 8 department of periodontology Sibar institute of dental sciences Takkellapadu guntur.
ANDHRA PRADESH 522509 India
Guntur
ANDHRA PRADESH |
7093156626
aishwaryagolapala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar institute of dental sciences, Guntur |
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 |
| Comparator Agent |
chlorhexidine gel |
Patients will recieve scaling and root planing along with chlorhexidine gel and patients followed up for 3 months for evaluating clinical parameters |
| Intervention |
Lactobacillus salivarius probiotic gel |
Patients will receive Lactobacillus salivarius probiotic gel at baseline along with scaling and root planing and patients will be followed up for 3 months for evaluating clinical parameters |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age 30 to 55 years
Not having received periodontal treatment for a minimum of 3 months prior to the study
Persistent periodontal pockets characterized by a PD greater than or equal to 5mm with positive BOP at baseline
Patients willing to participate in the study
Patients who are apparently healthy
|
|
| ExclusionCriteria |
| Details |
Presence of any systemic disease
Pregnant women and lactating mothers
Use of any form of tobacco
Having history of drug usage and allergy
Patients who are under periodontal therapy from the past 6 months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of clinical attachment level |
Baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of probing depth, Plaque index and Sulcular bleeding index |
Baseline and after 3 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/10/2025 |
| Date of Study Completion (India) |
03/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/02/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 study is a randomized, parallel group
clinical trial comparing the efficacy of lactobacillus salivarus probiotic gel
and chlorhexidine gel as
an adjunct to scaling and root planing in the management of stage two periodontitis patients.
probiotic
Lactobacillus salivarius has the potential to modify the oral environment through
antagonism to bacteria responsible for periodontal inflammation, including
bacteria of the red complex.
Patients
will be assessed for eligibility. Based on Inclusion and Exclusion criteria, At
the initial visit, all the patients will receive Supra gingival Scaling.
Patients will be recalled after one week and clinical parameters such as plaque
index, gingival index, pocket depth and clinical attachment level will be
recorded and subgingival scaling and root planning will be performed. |