Outcome Following Use of Different Concentrations of NaOCl as Wound Lavage and Hemostatic Agent in Partial Pulpotomy

NCT06433245 | Completed

• 1 other identifier: Ridhi Karwal
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomised control trial is to compare the effect of different concentrations of NaOCl on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. The main question it aims to answer are:

1. 1.clinical and radiographic outcome of partial pulpotomy following use of 5% and 3% NaOCl in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
2. 2.OHRQoL and pain experience after use of 5% and 3% NaOCl during partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

Conditions

Irreversible Pulpitis; Extremely Deep Caries; Partial Pulpotomy

Keywords

partial pulpotomy; sodium hypochlorite; mature permanent mandibular molars; hemostatic agent

Outcome Measures

Primary Outcomes (2)

• Clinical success rate

  Clinical criteria of success:- 1. No pain or discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Healthy soft tissues around teeth with no swelling, sinus tract.

  baseline to 12 months

• Radiographic success rate

  Radiographic success criteria:- 1. No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph. 2. Complete radiographic healing

  Baseline to 12 months

Secondary Outcomes (2)

• Post Operative Pain

  Baseline to 7 days

• OHRQoL assessment

  baseline and at 24 h, 2, 3, 4, 5, 6 and 7 days after the treatment, and then at 6 and 12 months.

Study Arms (2)

Control: 3% sodium hypochlorite

ACTIVE COMPARATOR

After partial pulpotomy procedure, pulp wound will be irrigated with 3% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 3% sodium hypochlorite on the amputated pulp.

Procedure: effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

Test: 5% sodium hypochlorite

EXPERIMENTAL

After partial pulpotomy procedure, pulp wound will be irrigated with 5% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 5% sodium hypochlorite on the amputated pulp.

Procedure: effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

Interventions

effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. PROCEDURE

After caries removal and pulp exposure pulp tissue is amputated and hemostasis is achieved with 3% sodium hypochlorite in control group and 5% sodium hypochlorite in experimental group followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.

Control: 3% sodium hypochlorite; Test: 5% sodium hypochlorite

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mature permanent mandibular molars.
• Teeth with clinical diagnosis of symptomatic irreversible pulpitis
• Patients having normal periapical status with periapical index (PAI) score ≤ 2
• Periodontally healthy teeth
• Patients having physical status of class 1 or 2 according to ASA classification
• Pulpal bleeding can be controlled within 6 minutes.
• Presence of extremely deep carious lesion on radiograph -

You may not qualify if:

• \) Non restorable teeth 2) Necrotic pulp evident upon exposure 3) Negative response to vitality test 4) Presence of sinus tract 5) Presence of soft tissue swelling 6) Radiographic signs of internal or external root resorption 7) Pregnant women

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PIGDS

Rohtak, Haryana, 124001, India

Location

Study Officials

• Dr. Pankaj Sangwan, MDS

  PGIDS, Rohtak, Haryana 124001

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The operator, patient and the outcome assessor will be masked to the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: May 23, 2024
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

IN (1)