| CTRI Number |
CTRI/2025/05/086986 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized controlled clinical trial comparing the efficacy of a locally delivered novel probiotic gel with 1 percent chlorhexidine gel in the non-surgical periodontal treatment of patients with stage II periodontitis |
|
Scientific Title of Study
|
Comparative clinical evaluation of locally delivered ingenious probiotic gel with 1 percent chlorhexidine gel in the nonsurgical periodontal treatment of stage II periodontitis patients 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 |
Darshana Borawake |
| Designation |
Post graduate student |
| Affiliation |
MGVS KBH Dental college and Hospital, Panchavati, Nashik |
| Address |
04, First floor, Siddhesh pride,Anusuyanagar, takli road, TAPOVAN, NASHIK
Mahatma Gandhi Vidyamandirs, Karmaveer Bhausaheb Hiray, Dental college and Hospital, Panchavati, Nashik
Nashik
MAHARASHTRA
422011
India |
| Phone |
8090020029 |
| Fax |
|
| Email |
1999borawakedarshana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kunal S Sethi |
| Designation |
Professor and PG guide |
| Affiliation |
MGVS KBH Dental college and Hospital, Panchavati, Nashik |
| Address |
Mahatma Gandhi Vidyamandirs Karmaveer Bhausaheb Hiray Dental college and Hospital Panchavati Nashik
Mahatma Gandhi Vidyamandirs Karmaveer Bhausaheb Hiray Dental college and Hospital Panchavati Nashik
Nashik
MAHARASHTRA
422011
India |
| Phone |
98230-20048 |
| Fax |
|
| Email |
kunalks2001@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Darshana Borawake |
| Designation |
Post graduate student |
| Affiliation |
MGVS KBH Dental college and Hospital, Panchavati, Nashik |
| Address |
04, First floor, Siddhesh pride,Anusuyanagar, takli road, TAPOVAN, NASHIK
Mahatma Gandhi Vidyamandirs, Karmaveer Bhausaheb Hiray, Dental college and Hospital, Panchavati, Nashik
Nashik
MAHARASHTRA
422011
India |
| Phone |
8090020029 |
| Fax |
|
| Email |
1999borawakedarshana@gmail.com |
|
|
Source of Monetary or Material Support
|
| The study will be conducted in department of periodontology of MGVS KBH Dental college Panchavati Nashik Maharashtra |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 Darshana Borawake |
MGVS KBH Dental College and Hospital |
303, second floor, Department of Periodontology and Implantology
Nashik
MAHARASHTRA |
7262075100
1999borawakedarshana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBH,Dental College institutional 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 |
Group A: Probiotic gel group |
Probiotic gel is to be administered in this group of patients after non surgical periodontal therapy. |
| Comparator Agent |
Group B: Chlorhexidine gel group |
Chlorhexidine (hexi-gel) gel will be administered in this group of patients after non-surgical periodontal therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients within age group of 18 – 45 years.
b. Stage II periodontitis patients with at least two non-adjacent teeth with probing depth 3 to 4 mm
|
|
| ExclusionCriteria |
| Details |
a. Patients with chronic diseases such as Diabetes mellitus, arthritis, thyroid disorder, etc.
b. Patients using protective or orthodontic appliances.
c. Patients who are smokers or using any other tobacco products.
d. Female patients who are pregnant and lactating.
e. Patient allergic to probiotics
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The expected outcome is reduction in gingival inflammation, Pocket probing depth, gingival bleeding and increase in clinical attachment level. |
At baseline, 4 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In-vitro outcome is expected to be zone of inhibition to be seen on nutrient agar plate with probiotic gel against aerobic and anaerobic bacteria collected from plaque samples from stage II periodontitis patients |
zone of inhibition to be recorded in 24 hours after smearing the plaque samples and probiotic gel on nutrient agar plate |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2025 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Data will be available after publishing the article
- For how long will this data be available start date provided 12-07-2025 and end date provided 12-07-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Basically,
this study is intended to compare the effect of additional local delivery of
two antimicrobial gel in addition to the effect seen due to teeth cleaning.
These
gels will be administered in the form of local drug delivery (local drug
delivery is a type of drug which when administered in the gums have an action
of slowly releasing the drug which will help to remove the bad bacteria and
heal the gum tissues).
Chlorhexidine
gel is a gold standard which has excellent results in periodontal treatment and
is widely used. Due to its long-term use, it shows few side effects (like
yellowish discoloration of teeth, metallic taste, etc.). Therefore, to overcome this we have come
up with probiotics gel which has no such side effects so far and there are many
studies conducted on probiotics confirming its safety and benefits for
enhancing the periodontal health.
There
will be total 40 patients included in this study. They will be assigned into two
groups, group A which will receive 1% chlorhexidine gel® administration followed
by non-eugenol coe pack; group B will receive probiotic gel administration
followed by non-eugenol coe pack (non-eugenol coe-pack means a healing paste
which when applied after gel administration gets hardened in few mins and stays
for few days. This pack is given so that it will keep the administered gel on
place). |