| CTRI Number |
CTRI/2025/12/099370 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which root canal irrigant works better - Plantaricin-149 or Chlorhexidine? A study on pain and infection |
|
Scientific Title of Study
|
The effect of antimicrobial peptide plantaricin-149 in comparison with chlorhexidine as final root canal irrigant on the reduction of microbial load and postoperative pain in root canals with necrotic pulp - a randomised 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 |
Dr Nibedita Sahoo |
| Designation |
Post graduate student |
| Affiliation |
S.C.B Dental College and Hospital, Cuttack |
| Address |
Department of Conservative Dentistry and Endodontics, S.C.B Dental College and Hospital, Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
7978603144 |
| Fax |
|
| Email |
nibedita545kunu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Rekha Mallick |
| Designation |
Assistant Professor |
| Affiliation |
S.C.B Dental College and Hospital, Cuttack |
| Address |
Department of Conservative Dentistry and Endodontics, S.C.B Dental College and Hospital, Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
8895708553 |
| Fax |
|
| Email |
drrashmiendo1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nibedita Sahoo |
| Designation |
Post graduate student |
| Affiliation |
S.C.B Dental College and Hospital, Cuttack |
| Address |
Department of Conservative Dentistry and Endodontics, S.C.B Dental College and Hospital, Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
7978603144 |
| Fax |
|
| Email |
nibedita545kunu@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.C.B Dental College and Hospital, Cuttack |
|
|
Primary Sponsor
|
| Name |
Dr Nibedita Sahoo |
| Address |
Department of Conservative Dentistry and Endodontics, S.C.B Dental College and Hospital, Cuttack, pin- 753007, Odisha |
| 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 Nibedita Sahoo |
S.C.B Dental College and Hospital, Cuttack |
First floor, Department of Conservative Dentistry and Endodontics,PIN-753007,Cuttack
Cuttack
ORISSA |
7978603144
nibedita545kunu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC) SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK, ODISHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine |
2% Chlorhexidine will be used as final irrigant |
| Intervention |
Peptide Plantaricin-149 |
0.013% Plantaricin-149 antimicrobial peptide will be used as final irrigant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Single rooted tooth
2. Presence of one root canal
3. Patients whose teeth have pulp necrosis, which will be confirmed by
absence of a response to pulp sensitivity tests and radiographic
evidence of apical periodontitis or periapical radiolucency.
4. Age of the patients:18 – 35 years old
5. No spontaneous pre-treatment pain or at the time of the appointment. |
|
| ExclusionCriteria |
| Details |
1. Root canal treated teeth
2. Patients who used antibiotics in the past 3 months
3. Any known systemic disease
4. Teeth that could not be properly isolated
5. Advanced Periodontal disease
6. Incomplete root formation |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Microbial load reduction |
S1-After access opening and before cleaning and shaping
S2-After irrigation with sodium hypochlorite and EDTA
S3- After final irrigation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain evaluation |
After 24 hours,
48 hours and
7th day |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
OBJECTIVES To compare and evaluate
the effect of antimicrobial peptide Plantaricin-149 in comparison with
chlorhexidine as final root canal irrigant solution on the reduction of
microbial load and postoperative pain NULL HYPOTHESIS There will be no
difference in bacterial count reduction between two groups of final irrigating
solutions and no influence of the final irrigating solutions on postoperative
pain STUDY PROTOCOL Local anaesthesia 2%
lidocaine with 1:100000 epinephrine will be given. Rubber dam isolation will be
done and access cavity preparation will be performed to obtain straight-line
canal access. Canal exploration will be done with a size 10 K-file, and working
length will be determined using an electronic apex locator and confirmed
radiographically. Sample 1 (S1) will be collected using three sterile size-20
paper points inserted sequentially to full working length for 60 seconds each.
Root canal instrumentation will then be performed with rotary instruments.
After each instrumentation, irrigation will be done with 2 mL of 3% NaOCl using
a 30-G side-vented needle, followed by a 3 mL sterile saline rinse. Smear layer
will be removed with 5 mL of 17% EDTA and passive ultrasonic activation for 60
seconds, followed by a saline rinse. Patency will be confirmed with a size 20
K-file. Sample 2 (S2) will be obtained similarly. Final irrigation (5 mL, 90
sec) will be performed using the assigned solution—Group 1: 0.013% Plantaricin
149 peptide, Group 2: 2% Chlorhexidine—followed by passive ultrasonic
activation for 60 seconds. Sample 3 (S3) will then be collected as per previous
sampling procedures. All paper points from S1, S2, and S3 will be immediately
transferred to Cryotubes containing buffer, stored at –20°C, and transported
for qPCR analysis. The access cavity will be sealed with a 2 mm temporary
restoration. After 7 days, obturation
followed by composite restoration will be done. Postoperative pain will be
recorded at 24 h, 48 h, and 7 days using a modified VAS scale (1–none,
2–slight, 3–moderate, 4–severe). Pain reporting will be obtained via scheduled
telephone follow-up. Analgesic requirements will be documented, and Ibuprofen
400 mg will be provided in case of emergency.
|