Compare the Impact of Sodium Hypochlorite and Saline Irrigation Protocols With and Without Cryotherapy on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth. "Randomized Controlled Trial"

NCT07764666 | Enrolling By Invitation DMC

• 1 other identifier: FUE.REC(16)/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 and saline irrigation protocols with and without cryotherapy on post-operative pain following pulpotomy in permanent mandibular molar teeth.Will the use of sodium hypochlorite and saline irrigation protocols with and without cryotherapy have an effect on post-operative pain and overall success following pulpotomy in permanent mandibular molar compared to normal saline irrigation ?

Conditions

Post-operative Pain; Vital Pulp Therapy

Keywords

cryotherapy /pulpotomy /post operative pain

Outcome Measures

Primary Outcomes (1)

• post operative pain

  Postoperative pain reported by the patient after pulpotomy in groups is to be recorded by NRS (Numerical Rate Scale). Scale from 0-10 recorded every 24hours until the seventh day. The NRS for pain is a straight line with one end (point 0) meaning no pain and the other end (point 10) meaning the worst pain imaginable.

  Pain will be recorded preoperative and after 6 hours, 12 hours , 24 hours , 72 hours and 1 week using numerical rate scale (NRS)

Secondary Outcomes (1)

• Clinical and Digital radiograph overall success

  3 month ,6 month and 12 month

Study Arms (3)

2.5% NAOCL

EXPERIMENTAL

intervention group and the pulpotomy irrigation agent will be NAOCL2.5%.

Procedure: VPT /pulpotomy

cryotherapy enhanced with 2.5% NAOCL

EXPERIMENTAL

the intervention group and the pulpotomy irrigation agent will be cryotherapy with NAOCL2.5%.

Procedure: VPT/complete pulpotomy

cryotherapy enhanced with saline

EXPERIMENTAL

the intervention group and the pulpotomy irrigation agent will be cryotherapy with saline

Procedure: vital pulp therapy /complete pulpotomy

Interventions

VPT /pulpotomy 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.

2.5% NAOCL

VPT/complete pulpotomy 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.

cryotherapy enhanced with 2.5% NAOCL

vital pulp therapy /complete pulpotomy 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.

cryotherapy enhanced with saline

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

• Abdelrahman Refaat Khalaf Ahmed: lead

Study Sites (1)

Faculty of Oral and Dental Medicine future university, Cairo,

Cairo, Cairo Governorate, 11835, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

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: SPONSOR INVESTIGATOR
• PI Title: B.D.S dental college

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 14, 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)