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Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite

NCT07748676 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-08-06

No results posted yet for this study

Summary

The aim of this randomised control trial is to compare the effect of wound lavage using 2.5% Ca(OCl)₂ and 2.5% NaOCl on the outcome of partial pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis (SIP).Primary objective is to evaluate and compare clinical and radiographic outcome of partial pulpotomy following use of 2.5% Ca(OCl)₂ and 2.5% NaOCl in mature permanent mandibular molars with symptomatic irreversible pulpitis.secondary objective is to evaluate OHRQoL and pain experience after use of 2.5% Ca(OCl)₂ and 2.5% NaOCl during partial pulpotomy in permanent mandibular molars with clinical signs indicative of symptomatic irreversible pulpitis.

Conditions

  • Symptomatic Irreversible Pulpitis (SIP)
  • Extremely Deep Caries

Interventions

PROCEDURE

Partial pulpotomy using calcium hypochlorite as wound lavage agent

Following pulp exposure and clinical assessment of pulp health through bleeding, the patient was randomly assigned to 2.5% Ca(OCl)₂ group.Patients who did not exhibit pulp exposure after complete caries removal, or those with partially necrotic pulp, were excluded from the study. The pulp wound was irrigated with 5 ml 2.5% Ca(OCl)₂ for 30 s. Haemostasis was achieved by placing the cotton pellets soaked with 2.5% Ca(OCl)₂ over the pulpal wound for 2 min. This process was repeated further if required, for a maximum of 10 min. Patients whose bleeding could not be arrested within 10 min had to undergo CP or pulpectomy. ProRoot MTA will be placed to a thickness of 2-3 mm gently over the pulpal tissue, a layer of RMGIC will be placed over the MTA.Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.

PROCEDURE

Partial pulpotomy using sodium hypochlorite as wound lavage agent

Following pulp exposure and clinical assessment of pulp health through bleeding, the patient was randomly assigned to 2.5% NaOCl group.Patients who did not exhibit pulp exposure after complete caries removal, or those with partially necrotic pulp, were excluded from the study. The pulp wound was irrigated with 5 ml 2.5% NaOCl for 30 s. Haemostasis was achieved by placing the cotton pellets soaked with 2.5% NaOCl over the pulpal wound for 2 min. This process was repeated further if required, for a maximum of 10 min. Patients whose bleeding could not be arrested within 10 min had to undergo CP or pulpectomy. ProRoot MTA will be placed to a thickness of 2-3 mm gently over the pulpal tissue, a layer of RMGIC will be placed over the MTA.Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.

Sponsors & Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

    lead OTHER

Principal Investigators

  • Dr Mayank Arora, MDS · PGIDS, Rohtak, 124001

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-29
Primary Completion
2027-10-28
Completion
2027-10-28

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07748676 on ClinicalTrials.gov