Outcome Following Use of NaOCl and Chlorhexidine as Wound Lavage Agents

NCT06240130 | Completed

• 1 other identifier: Soumyashree Mishra
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to to compare effect of wound lavage agents NaOCl and Chlorhexidine on the outcome of partial pulpotomy in mature permanent posterior teeth with signs and symptoms indicative of irreversible pulpitis in. The main question it aims to answer are: Does wound lavage using chlorhexidine have equal effect as NaOCl on the outcome of partial pulpotomy in mature permanent mandibular posterior teeth with clinical signs of irreversible pulpitis? Participants will of age group 18 to 45 years will be included and divided into two groups: Pulp wound lavage in partial pulpotomy using 3% NaOCl as control and using 2% Chlorhexidine as experiment

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Clinical Success and Radiographic Success

  CLINICAL SUCCESS CRITERIA: Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion. RADIOGRAPHIC SUCCESS CRITERIA: No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique. Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.

  Base line to 12 months

Secondary Outcomes (1)

• Post operative pain

  Base line to 7 days

Study Arms (2)

Sodium hypochlorite lavage group

ACTIVE COMPARATOR

3% sodium hypochlorite lavage will be done after pulp amputation

Procedure: Partial pulpotomy

Chlorhexidine lavage group

EXPERIMENTAL

2% Chlorhexidine lavage will be done after pulp amputation

Procedure: Partial pulpotomy

Interventions

Partial pulpotomy PROCEDURE

after caries removal and pulp exposure pulp tissue is amputated and wound lavage done with 3% NaOCl in partial pulpotomy

Sodium hypochlorite lavage group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mature permanent mandibular posterior teeth with extreme deep caries and clinical diagnosis of symptomatic irreversible pulpitis
• Patients having normal periapical status with periapical index (PAI) score ≤ 2 and periodontally healthy teeth
• Patients having physical status of class 1 or 2 according to ASA classification
• Pulpal bleeding can be controlled within 10 minutes

You may not qualify if:

• Necrotic pulp upon exposure
• Presence of sinus tract or soft tissue swelling Pregnant patients Radiographic signs of internal or external root resorption

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

Related Publications (1)

• Mishra S, Sangwan P, Duhan J, Arora M, Mittal S, Kumar V, Ramani A. Outcome of Partial Pulpotomy in Mature Permanent Molars After Lavage With Chlorhexidine or Sodium Hypochlorite: A Randomised Clinical Trial. Int Endod J. 2026 Jan;59(1):80-90. doi: 10.1111/iej.70043. Epub 2025 Sep 30.

  PMID: 41026352 DERIVED

Study Officials

• DR. Sanjay Tewari, MDS

  PGIDS,Rohtak, Haryana, 124001

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: February 2, 2024
• Study Start: July 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

IN (1)