Impact of Sodium Hypochlorite Irrigation at Different Concentrations, With and Without Cryotherapy, on Post Operative Pain in Permanent Mandibular Molar Teeth.

NCT07771816 | Enrolling By Invitation DMC

• 1 other identifier: FUE.REC(5)/1-2026
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study will compare the impact of sodium hypochlorite irrigation at different concentrations with and without cryotherapy on post operative pain in permanent mandibular molar teeth. Will cryotherapy combined with sodium hypochlorite irrigation at different concentrations reduce postoperative pain in compared to conventional sodium hypochlorite irrigation during pulpotomy of mandibular molar teeth with symptomatic irreversible pulpitis?

Conditions

Postoperative Pain; Vital Pulp Therapies

Keywords

cryotherapy; pulpotomy

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  numerical rate scale (NRS), ranging from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain.

  Pain will be assessed at baseline (preoperatively) and postoperatively at 6 hours, 12 hours , 24 hours , 72 hours and 1week after treatment.

Secondary Outcomes (1)

• overall success

  3 months, 6 months and 12 months after treatment

Study Arms (3)

1.5% NaOCl irrigation at room temperature.

EXPERIMENTAL

vital pulp therapy with 1.5% NaOCl irrigation at room temperature.

Procedure: vital pulp therapy

cryo treated 1.5% NaOCl irrigation.

EXPERIMENTAL

Vital pulp therapy with cryo treated 1.5% NaOCl irrigation.

Procedure: vital pulp therapy

cryo treated 2.5% NaOCl irrigation.

EXPERIMENTAL

Vital pulp therapy with cryo treated 2.5% NaOCl irrigation.

Procedure: vital pulp therapy

Interventions

vital pulp therapy PROCEDURE

Endodontic procedure: The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2) under an operating surgical microscope. The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp. Hemostasis will be achieved by irrigating the prepared cavity with volume 3ml of irrigant for up to 6 minutes over the pulp stump. If hemostasis cannot be achieved after 6 mins, the tooth should undergo pulpectomy and Root Canal treatment as per the clinician's normal practice.

1.5% NaOCl irrigation at room temperature.

Eligibility Criteria

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

You may qualify if:

• Tooth show positive response to sensitivity test.
• Haemostasias can be achieved after total pulpotomy.
• The tooth is restorable and free from advanced periodontal disease, cracks and splits.
• Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars teeth only will be involved.
• Patients of either gender aged from 15-40.
• Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
• Patients who will agree to the consent and will commit to follow-up period.
• Patients with mature root.
• Patients with no internal or external resorption and no periapical lesions.
• Soft tissues around the tooth are normal with no swelling or sinus tract.

You may not qualify if:

• Patients with immature roots.
• Haemostasias after 10 minutes can not be controlled after total pulpotomy
• Patients with any systemic disease that may affect normal healing.
• Patients with periapical lesions or infections.
• Pregnant females.
• Patients who could/would not participate in a 6 months follow-up.
• Patients with fistula or swelling
• Patients with necrotic pulp.
• Patients with old age.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

faculty of oral and dental medicine Future University in Egypt

Cairo, Cairo Governorate, 11835, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 18, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Beginning of 2026, a year after publication, with no end date

Locations

EG (1)