Comparison of Sodium Hypochlorite Gel and Solution With and Without Nanoparticles for Postoperative Pain After Pulpotomy in Permanent Mandibular Molars

Summary

This randomized clinical trial aims to compare the effect of 2% sodium hypochlorite gel and solution, with and without chitosan nanoparticles, on postoperative pain following pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis. Participants will be randomly allocated into four parallel groups receiving either 2% sodium hypochlorite solution, 2% sodium hypochlorite gel, 2% sodium hypochlorite solution containing chitosan nanoparticles, or 2% sodium hypochlorite gel containing chitosan nanoparticles as the haemostatic agent during pulpotomy. Postoperative pain will be assessed using an 11-point Numerical Rating Scale at 6, 12, 24, and 72 hours and 7 days after treatment. The study will also evaluate the overall clinical and radiographic success of pulpotomy during follow-up.

Conditions

• Vital Pulp Therapies
• Pulpotomy
• Irriversible Pulpitis
• Postoperative Pain

Interventions

PROCEDURE

Sodium Hypochlorite gel 2%

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). 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 a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into; • Group A which will be the intervention group and hemostasis is NaOCL gel 2%.

PROCEDURE

Sodium hypochlorite gel 2% with chitosan nano particles

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). 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 a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into; • Group B which will be the intervention group and hemostasis is NaOCL gel 2% with chotosan nanoparticles

PROCEDURE

Sodium hypochlorite solution 2% with chitosan nanoparticles

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). 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 a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into; • Group C which will be the intervention group and hemostasis is NaOCL solution 2% with chitosan nanoparticles

PROCEDURE

Sodium hypochlorite solution 2%

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). 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 a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into; • Group D which will be the intervention group and hemostasis is NaOCL solut 2%.

Sponsors & Collaborators

• Future University in Egypt

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2026-04-01

Completion

2027-03-01

Countries

• Egypt

Study Locations