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NCT Number: NCT07774130

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Vital Pulp Therapies Irriversible Pulpitis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Pulpotomy Signs and Symptoms

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University

Cairo, 11511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars.
  • Patients of either gender aged from 15-40.
  • Patients 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.
  • Tooth give positive response to sensitivity test.
  • Tooth is restorable and free from advanced periodontal disease, cracks and splits.
  • Hemostasis achieved after total pulpotomy.
  • Soft tissues around the tooth are normal with no swelling or sinus tract.

Exclusion criteria

  • • Hemostasis after 10 minutes can not be controlled after total pulpotomy.
  • Patients with immature roots.
  • 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.

Treatment and study plan

Sodium Hypochlorite gel 2%

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).

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%.

Sodium hypochlorite gel 2% with chitosan nano particles

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).

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

Sodium hypochlorite solution 2% with chitosan nanoparticles

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).

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

Sodium hypochlorite solution 2%

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).

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%.

Primary outcomes

  1. Post-operative pain

    Time frame: Pain will be recorded preoperative and after 6hours, 12hours, 24hours, 72hours and one week using numerical rate scale (NRS).

    • Postoperative pain reported by the patient after pulpotomy in both 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.

Secondary outcomes

  1. Clinical and Radiographic Overall success

    Time frame: 3, 6, 12, months

    Overall treatment success will be assessed clinically and radiographically at 3, 6, and 12 months after treatment. A participant will be considered successful only if both clinical and radiographic success criteria are met. Clinical success will be defined as the absence of spontaneous pain, swelling, sinus tract, tenderness, abnormal mobility, or abnormal periodontal probing depth. Radiographic success will be defined as the absence of new or increased periapical radiolucency. Failure of either the clinical or radiographic criteria will be considered treatment failure.

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Comparative Evaluation of Sodium Hypochlorite Gel and Solution, With and Without Nano-particles, on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth; "Randomized Clinical Trail"

Acronym: NaOCl Pulpotom

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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