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

NCT07748676 | Recruiting

• 1 other identifier: Roshni N V
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

partial pulpotomy

Outcome Measures

Primary Outcomes (1)

• Success rate at 12 months

  Criteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and 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. Absence of associated soft tissue swelling, sinus or fistula. Radiographic: - 1. Absence of any periapical or interradicular radiolucency. 2. Complete radiographic healing (PAI score 1 or 2 acc. to Ostravik et al). 3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.

  12 months

Secondary Outcomes (2)

• Postoperative pain

  Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

• OHRQoL assessment

  Baseline and at 24 hours, Day1,Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

Study Arms (2)

Partial pulpotomy using calcium hypochlorite as wound lavage agent

EXPERIMENTAL

Partial pulpotomy will be performed using calcium hypochlorite as wound lavage agent ,after establishing a clinical diagnosis of symptomatic irreversible pulpitis i.e. if the tooth showed symptoms triggered and lingered by cold stimuli.

Procedure: Partial pulpotomy using calcium hypochlorite as wound lavage agent

Partial pulpotomy using sodium hypochlorite as wound lavage agent

ACTIVE COMPARATOR

Partial pulpotomy will be performed using sodium hypochlorite as wound lavage agent ,after establishing a clinical diagnosis of symptomatic irreversible pulpitis i.e. if the tooth showed symptoms triggered and lingered by cold stimuli.

Procedure: Partial pulpotomy using sodium hypochlorite as wound lavage agent

Interventions

Partial pulpotomy using calcium hypochlorite as wound lavage agent PROCEDURE

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.

Partial pulpotomy using calcium hypochlorite as wound lavage agent

Partial pulpotomy using sodium hypochlorite as wound lavage agent PROCEDURE

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.

Partial pulpotomy using sodium hypochlorite as wound lavage agent

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients aged 18-40 years
• Mature permanent mandibular molars with extremely deep caries (caries penetrating the entire thickness of the dentine radiographically, without radiopaque zone separating lesion from the pulp) and clinical diagnosis of SIP with PAI score ≤ 2
• Periodontally healthy teeth (probing pocket depth ≤3 mm and mobility within normal limit)
• Patients having physical status of class 1 or 2 according to ASA classification
• Pulpal bleeding could be controlled within 10 min following pulp amputation

You may not qualify if:

• Non restorable teeth
• No pulp exposure even after complete caries excavation
• Necrotic or partially necrotic pulp upon exposure
• Presence of sinus tract or soft tissue swelling
• Radiographic signs of internal or external root resorption
• Pregnant women

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

Study Officials

• Dr Mayank Arora, MDS

  PGIDS, Rohtak, 124001

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Mayank Arora, MDS

CONTACT

+918295964200; dr.arora002@gmail.com

Dr. Roshni N V, PG student

CONTACT

+919048217877; roshninv1997@gmail.com

Study Design

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

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): October 28, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

IN (1)