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Clinical Trials/CTRI/2025/12/099370
CTRI/2025/12/099370Not yet recruitingPhase 4

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

Dr Nibedita Sahoo1 site in 1 country40 target enrollmentStarted: January 1, 2026Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Microbial load reduction

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 35.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Single rooted tooth
  • Presence of one root canal
  • 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.
  • Age of the patients:18 – 35 years old
  • No spontaneous pre-treatment pain or at the time of the appointment.

Exclusion Criteria

  • Root canal treated teeth
  • Patients who used antibiotics in the past 3 months
  • Any known systemic disease
  • Teeth that could not be properly isolated
  • Advanced Periodontal disease
  • Incomplete root formation.

Outcomes

Primary Outcomes

Microbial load reduction

Time Frame: S1-After access opening and before cleaning and shaping | S2-After irrigation with sodium hypochlorite and EDTA | S3- After final irrigation

Secondary Outcomes

  • Postoperative pain evaluation(After 24 hours,)

Investigators

Sponsor
Dr Nibedita Sahoo
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Nibedita Sahoo

S.C.B Dental College and Hospital, Cuttack

Study Sites (1)

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